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出境医 / 临床实验 / Proton Accelerated Partial Breast Irradiation (APBI)

Proton Accelerated Partial Breast Irradiation (APBI)

Study Description
Brief Summary:

This prospective, non-randomized phase II study will evaluate the cosmetic outcome of using pencil beam scanning proton therapy for partial breast irradiation in patients diagnosed with early stage breast cancer. In addition the study will evaluate the acute and late toxicities, and the rates of ipsilateral breast tumor recurrence, both in situ and invasive disease.

To qualify for the trial, patients must be 50 years or older and have stage 0 (carcinoma in situ) or stage IA or IIA invasive carcinoma of the breast with no evidence of metastatic disease. The tumor size must be 3cm or less. Women must have undergone a partial mastectomy with margins free of invasive cancer and at least a 2mm margin for in situ disease. Patients must have clinically node negative disease. Patients with invasive disease must also have nodal assessment performed with either sentinel lymph node biopsy or axillary lymph node dissection and patients must have pathologically node negative disease. Accelerated partial breast irradiation (APBI) will utilize pencil beam scanning proton therapy. Partial breast irradiation will be delivered twice a day, at least 6 hours apart, over 5 treatment days.

This trial is designed to accrue 21 patients over a period of three years.


Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Proton Accelerated Partial Breast Irradiation Phase 2

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study to Evaluate the Cosmetic Outcome of Using Pencil Beam Scanning Proton Therapy for Accelerated Partial Breast Irradiation in Early Stage Breast Cancer
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : May 31, 2024
Arms and Interventions
Arm Intervention/treatment
Experimental: Early Stage Breast Cancer
Patients to be treated with Accelerated Partial Breast Irradiation utilizing pencil beam scanning proton therapy. Treatment will be delivered twice a day, at least 6 hours apart, over 5 treatment days.
 Radiation: Proton Accelerated Partial Breast Irradiation
38.5 Cobalt Gray Equivalent (CGE) given over 10 fractions
Outcome Measures
Primary Outcome Measures :
  1. Cosmetic outcome (change in appearance as compared to untreated breast) [ Time Frame: Through Study Completion, an average of 2 years ]
    Breast Cancer Treatment Outcome Scale [8 (no difference) through 32 (large difference)]

  2. Cosmetic outcome (change in appearance as compared to untreated breast) [ Time Frame: Through Study Completion, an average of 2 years ]
    Physician and Nurse Harvard Cosmesis Scale [1 (excellent) through 4 (poor)]


Secondary Outcome Measures :
  1. Rates of acute (within 3 months of treatment) toxicity [ Time Frame: Through Study Completion, an average of 2 years ]
    Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  2. Rates of late (> 3 months after treatment) toxicity [ Time Frame: Through Study Completion, an average of 2 years ]
    Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  3. Rate of ipsilateral breast tumor recurrence, including both in situ and invasive disease. [ Time Frame: Through Study Completion, an average of 2 years ]
    Presence of invasive or ductal carcinoma in-situ in ipsilateral breast as confirmed by biopsy

  4. Rate of regional recurrence [ Time Frame: Through Study Completion, an average of 2 years ]
    Presence of tumor in the ipsilateral axillary, infraclavicular, supraclavicular or internal mammary lymph nodes.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must consent to be in the study and must have signed an approved consent form conforming with institutional guidelines.
  • Patients must be ≥ 50 years old.
  • Patients should have a life expectancy of at least 10 years taking into consideration comorbid conditions.
  • Surgical treatment of the breast must have been partial mastectomy. The margins of the resected specimen must be histologically free of tumor for invasive disease and with at least a 2mm margin for in situ disease. Reexcision of surgical margins is permitted to obtain negative margins. Postoperative mammogram of the surgical specimen or breast must be performed to confirm that all abnormal calcifications were removed at the time of surgery. Surgical clips must be placed at the partial mastectomy site by the surgeon at the time of excision.
  • Patients must have American Joint Committee on Cancer 8th edition pathology stage Tis, T1, or T2 and N0 as assessed by sentinel lymph node biopsy or axillary lymph node dissection for invasive disease. The tumor size must be 3cm or less in greatest dimension.
  • On histologic examination, the tumor must be ductal carcinoma in situ (low or intermediate grade), invasive ductal carcinoma (any grade), or invasive lobular carcinoma.
  • Patients must have unicentric disease with limited or focal lymphovascular space invasion (LVSI).
  • Patients must have an estrogen reception (ER) analysis performed and the primary tumor should be ER positive.
  • The target partial mastectomy cavity must be clearly delineated and the target partial mastectomy cavity/whole breast reference volume must be ≤ 30% based on the post- operative scan. The partial mastectomy cavity must be > 5mm from the skin. This can be confirmed at time of CT simulation for radiation treatment planning.
  • Patients must enroll within 42 days following the last surgery for breast cancer (partial mastectomy or re-excision of margins).
  • Proton APBI should start within 12 weeks from the time of surgery.

Exclusion Criteria:

  • Male
  • Patients < 50 years of age.
  • Tumor > 3cm in greatest dimension or American Joint Committee on Cancer 8th edition pathologic stage T3 or T4 or node positive disease.
  • If patients have invasive carcinoma and no nodal assessment was performed, specifically the patient did not undergo sentinel lymph node biopsy or axillary lymph node dissection.
  • Patients with persistently positive margins despite attempted re-excision.
  • Proven multicentric disease or extensive LVSI.
  • Clear delineation of the extent of the target partial mastectomy cavity is not possible.
  • Patients who have undergone oncoplastic reconstruction.
  • Any patients who received neoadjuvant chemotherapy or hormonal therapy prior to surgical excision of the tumor.
  • Any patients who require adjuvant chemotherapy following lumpectomy.
  • Patients whose primary tumor is ER negative.
  • Patients with high grade ductal carcinoma in situ.
  • Patients with known BRCA1 or BRCA2 mutation.
  • Prior breast or thoracic radiation and any prior breast surgery in the ipsilateral breast.
  • Patients with history of collagen vascular disease including scleroderma, lupus, polymyositis, or dermatomyositis.
  • Pregnancy.
Contacts and Locations

Locations
Layout table for location information
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
Tracking Information
First Submitted Date  ICMJE April 22, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date July 7, 2020
Estimated Study Start Date  ICMJE July 1, 2020
Estimated Primary Completion Date May 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
  • Cosmetic outcome (change in appearance as compared to untreated breast) [ Time Frame: Through Study Completion, an average of 2 years ]
    Breast Cancer Treatment Outcome Scale [8 (no difference) through 32 (large difference)]
  • Cosmetic outcome (change in appearance as compared to untreated breast) [ Time Frame: Through Study Completion, an average of 2 years ]
    Physician and Nurse Harvard Cosmesis Scale [1 (excellent) through 4 (poor)]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
  • Rates of acute (within 3 months of treatment) toxicity [ Time Frame: Through Study Completion, an average of 2 years ]
    Common Terminology Criteria for Adverse Events (CTCAE) v5.0
  • Rates of late (> 3 months after treatment) toxicity [ Time Frame: Through Study Completion, an average of 2 years ]
    Common Terminology Criteria for Adverse Events (CTCAE) v5.0
  • Rate of ipsilateral breast tumor recurrence, including both in situ and invasive disease. [ Time Frame: Through Study Completion, an average of 2 years ]
    Presence of invasive or ductal carcinoma in-situ in ipsilateral breast as confirmed by biopsy
  • Rate of regional recurrence [ Time Frame: Through Study Completion, an average of 2 years ]
    Presence of tumor in the ipsilateral axillary, infraclavicular, supraclavicular or internal mammary lymph nodes.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Proton Accelerated Partial Breast Irradiation
Official Title  ICMJE Phase II Study to Evaluate the Cosmetic Outcome of Using Pencil Beam Scanning Proton Therapy for Accelerated Partial Breast Irradiation in Early Stage Breast Cancer
Brief Summary

This prospective, non-randomized phase II study will evaluate the cosmetic outcome of using pencil beam scanning proton therapy for partial breast irradiation in patients diagnosed with early stage breast cancer. In addition the study will evaluate the acute and late toxicities, and the rates of ipsilateral breast tumor recurrence, both in situ and invasive disease.

To qualify for the trial, patients must be 50 years or older and have stage 0 (carcinoma in situ) or stage IA or IIA invasive carcinoma of the breast with no evidence of metastatic disease. The tumor size must be 3cm or less. Women must have undergone a partial mastectomy with margins free of invasive cancer and at least a 2mm margin for in situ disease. Patients must have clinically node negative disease. Patients with invasive disease must also have nodal assessment performed with either sentinel lymph node biopsy or axillary lymph node dissection and patients must have pathologically node negative disease. Accelerated partial breast irradiation (APBI) will utilize pencil beam scanning proton therapy. Partial breast irradiation will be delivered twice a day, at least 6 hours apart, over 5 treatment days.

This trial is designed to accrue 21 patients over a period of three years.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Radiation: Proton Accelerated Partial Breast Irradiation
38.5 Cobalt Gray Equivalent (CGE) given over 10 fractions
Study Arms  ICMJE Experimental: Early Stage Breast Cancer
Patients to be treated with Accelerated Partial Breast Irradiation utilizing pencil beam scanning proton therapy. Treatment will be delivered twice a day, at least 6 hours apart, over 5 treatment days.
Intervention: Radiation: Proton Accelerated Partial Breast Irradiation
Publications *
  • Howlader N, N.A., Krapcho M, Miller D, Bishop K, Kosary CL, Yu M, Ruhl J, Tatalovich Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA (eds). . SEER Cancer Statistics Review, 1975-2014, National Cancer Institute. . 2017; Available from: https://seer.cancer.gov/csr/1975_2014/
  • van Dongen JA, Voogd AC, Fentiman IS, Legrand C, Sylvester RJ, Tong D, van der Schueren E, Helle PA, van Zijl K, Bartelink H. Long-term results of a randomized trial comparing breast-conserving therapy with mastectomy: European Organization for Research and Treatment of Cancer 10801 trial. J Natl Cancer Inst. 2000 Jul 19;92(14):1143-50.
  • Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41.
  • Byun, D.J., et al., Omission of Adjuvant Radiation Therapy Following Breast Conservation Surgery for Ductal Carcinoma In Situ: Analysis of the National Cancer Data Base. International Journal of Radiation Oncology • Biology • Physics. 96(2): p. E38.
  • Feigelson HS, Carroll NM, Weinmann S, Haque R, Yu CL, Butler MG, Waitzfelder B, Wrenn MG, Capra A, McGlynn EA, Habel LA. Treatment patterns for ductal carcinoma in situ from 2000-2010 across six integrated health plans. Springerplus. 2015 Jan 17;4:24. doi: 10.1186/s40064-014-0776-7. eCollection 2015.
  • Fisher J, Scott C, Stevens R, Marconi B, Champion L, Freedman GM, Asrari F, Pilepich MV, Gagnon JD, Wong G. Randomized phase III study comparing Best Supportive Care to Biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoing breast irradiation: Radiation Therapy Oncology Group (RTOG) 97-13. Int J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1307-10.
  • Fernando IN, Ford HT, Powles TJ, Ashley S, Glees JP, Torr M, Grafton D, Harmer CL. Factors affecting acute skin toxicity in patients having breast irradiation after conservative surgery: a prospective study of treatment practice at the Royal Marsden Hospital. Clin Oncol (R Coll Radiol). 1996;8(4):226-33.
  • Krauss DJ, Kestin LL, Mitchell C, Martinez AA, Vicini FA. Changes in temporal patterns of local failure after breast-conserving therapy and their prognostic implications. Int J Radiat Oncol Biol Phys. 2004 Nov 1;60(3):731-40.
  • Polgár C, Fodor J, Major T, Németh G, Lövey K, Orosz Z, Sulyok Z, Takácsi-Nagy Z, Kásler M. Breast-conserving treatment with partial or whole breast irradiation for low-risk invasive breast carcinoma--5-year results of a randomized trial. Int J Radiat Oncol Biol Phys. 2007 Nov 1;69(3):694-702. Epub 2007 May 25.
  • Vicini F, Winter K, Wong J, Pass H, Rabinovitch R, Chafe S, Arthur D, Petersen I, White J, McCormick B. Initial efficacy results of RTOG 0319: three-dimensional conformal radiation therapy (3D-CRT) confined to the region of the lumpectomy cavity for stage I/ II breast carcinoma. Int J Radiat Oncol Biol Phys. 2010 Jul 15;77(4):1120-7. doi: 10.1016/j.ijrobp.2009.06.067. Epub 2009 Nov 10.
  • Chafe S, Moughan J, McCormick B, Wong J, Pass H, Rabinovitch R, Arthur DW, Petersen I, White J, Vicini FA. Late toxicity and patient self-assessment of breast appearance/satisfaction on RTOG 0319: a phase 2 trial of 3-dimensional conformal radiation therapy-accelerated partial breast irradiation following lumpectomy for stages I and II breast cancer. Int J Radiat Oncol Biol Phys. 2013 Aug 1;86(5):854-9. doi: 10.1016/j.ijrobp.2013.04.005. Epub 2013 May 29.
  • Vaidya JS, Bulsara M, Wenz F, Coombs N, Singer J, Ebbs S, Massarut S, Saunders C, Douek M, Williams NR, Joseph D, Tobias JS, Baum M. Reduced Mortality With Partial-Breast Irradiation for Early Breast Cancer: A Meta-Analysis of Randomized Trials. Int J Radiat Oncol Biol Phys. 2016 Oct 1;96(2):259-265. doi: 10.1016/j.ijrobp.2016.05.008. Epub 2016 May 13. Review.
  • Correa C, Harris EE, Leonardi MC, Smith BD, Taghian AG, Thompson AM, White J, Harris JR. Accelerated Partial Breast Irradiation: Executive summary for the update of an ASTRO Evidence-Based Consensus Statement. Pract Radiat Oncol. 2017 Mar - Apr;7(2):73-79. doi: 10.1016/j.prro.2016.09.007. Epub 2016 Sep 17.
  • Wang X, Amos RA, Zhang X, Taddei PJ, Woodward WA, Hoffman KE, Yu TK, Tereffe W, Oh J, Perkins GH, Salehpour M, Zhang SX, Sun TL, Gillin M, Buchholz TA, Strom EA. External-beam accelerated partial breast irradiation using multiple proton beam configurations. Int J Radiat Oncol Biol Phys. 2011 Aug 1;80(5):1464-72. doi: 10.1016/j.ijrobp.2010.04.052. Epub 2010 Aug 12.
  • Taghian AG, Kozak KR, Katz A, Adams J, Lu HM, Powell SN, DeLaney TF. Accelerated partial breast irradiation using proton beams: Initial dosimetric experience. Int J Radiat Oncol Biol Phys. 2006 Aug 1;65(5):1404-10. Epub 2006 May 26.
  • Wisenbaugh ES, Andrews PE, Ferrigni RG, Schild SE, Keole SR, Wong WW, Vora SA. Proton beam therapy for localized prostate cancer 101: basics, controversies, and facts. Rev Urol. 2014;16(2):67-75.
  • Hall EJ. Intensity-modulated radiation therapy, protons, and the risk of second cancers. Int J Radiat Oncol Biol Phys. 2006 May 1;65(1):1-7. Review.
  • Bush DA, Slater JD, Garberoglio C, Do S, Lum S, Slater JM. Partial breast irradiation delivered with proton beam: results of a phase II trial. Clin Breast Cancer. 2011 Aug;11(4):241-5. doi: 10.1016/j.clbc.2011.03.023. Epub 2011 Jun 12.
  • Galland-Girodet S, Pashtan I, MacDonald SM, Ancukiewicz M, Hirsch AE, Kachnic LA, Specht M, Gadd M, Smith BL, Powell SN, Recht A, Taghian AG. Long-term cosmetic outcomes and toxicities of proton beam therapy compared with photon-based 3-dimensional conformal accelerated partial-breast irradiation: a phase 1 trial. Int J Radiat Oncol Biol Phys. 2014 Nov 1;90(3):493-500. doi: 10.1016/j.ijrobp.2014.04.008. Epub 2014 May 29.
  • Kozak KR, Smith BL, Adams J, Kornmehl E, Katz A, Gadd M, Specht M, Hughes K, Gioioso V, Lu HM, Braaten K, Recht A, Powell SN, DeLaney TF, Taghian AG. Accelerated partial-breast irradiation using proton beams: initial clinical experience. Int J Radiat Oncol Biol Phys. 2006 Nov 1;66(3):691-8.
  • Moon SH, Shin KH, Kim TH, Yoon M, Park S, Lee DH, Kim JW, Kim DW, Park SY, Cho KH. Dosimetric comparison of four different external beam partial breast irradiation techniques: three-dimensional conformal radiotherapy, intensity-modulated radiotherapy, helical tomotherapy, and proton beam therapy. Radiother Oncol. 2009 Jan;90(1):66-73. doi: 10.1016/j.radonc.2008.09.027. Epub 2008 Nov 5.
  • Kanai T, Kawachi K, Kumamoto Y, Ogawa H, Yamada T, Matsuzawa H, Inada T. Spot scanning system for proton radiotherapy. Med Phys. 1980 Jul-Aug;7(4):365-9.
  • Stanton AL, Krishnan L, Collins CA. Form or function? Part 1. Subjective cosmetic and functional correlates of quality of life in women treated with breast-conserving surgical procedures and radiotherapy. Cancer. 2001 Jun 15;91(12):2273-81.
  • Olivotto IA, Whelan TJ, Parpia S, Kim DH, Berrang T, Truong PT, Kong I, Cochrane B, Nichol A, Roy I, Germain I, Akra M, Reed M, Fyles A, Trotter T, Perera F, Beckham W, Levine MN, Julian JA. Interim cosmetic and toxicity results from RAPID: a randomized trial of accelerated partial breast irradiation using three-dimensional conformal external beam radiation therapy. J Clin Oncol. 2013 Nov 10;31(32):4038-45. doi: 10.1200/JCO.2013.50.5511. Epub 2013 Jul 8.
  • Julian, T.B., et al., Early Toxicity Results with 3-D Conformal External Beam Therapy (CEBT) from the NSABP B-39/RTOG 0413 Accelerated Partial Breast Irradiation (APBI) Trial. International Journal of Radiation Oncology • Biology • Physics. 81(2): p. S7.
  • Vrieling C, Collette L, Fourquet A, Hoogenraad WJ, Horiot JC, Jager JJ, Pierart M, Poortmans PM, Struikmans H, Van der Hulst M, Van der Schueren E, Bartelink H. The influence of the boost in breast-conserving therapy on cosmetic outcome in the EORTC "boost versus no boost" trial. EORTC Radiotherapy and Breast Cancer Cooperative Groups. European Organization for Research and Treatment of Cancer. Int J Radiat Oncol Biol Phys. 1999 Oct 1;45(3):677-85.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: May 3, 2019) 		21
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2024
Estimated Primary Completion Date May 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The patient must consent to be in the study and must have signed an approved consent form conforming with institutional guidelines.
  • Patients must be ≥ 50 years old.
  • Patients should have a life expectancy of at least 10 years taking into consideration comorbid conditions.
  • Surgical treatment of the breast must have been partial mastectomy. The margins of the resected specimen must be histologically free of tumor for invasive disease and with at least a 2mm margin for in situ disease. Reexcision of surgical margins is permitted to obtain negative margins. Postoperative mammogram of the surgical specimen or breast must be performed to confirm that all abnormal calcifications were removed at the time of surgery. Surgical clips must be placed at the partial mastectomy site by the surgeon at the time of excision.
  • Patients must have American Joint Committee on Cancer 8th edition pathology stage Tis, T1, or T2 and N0 as assessed by sentinel lymph node biopsy or axillary lymph node dissection for invasive disease. The tumor size must be 3cm or less in greatest dimension.
  • On histologic examination, the tumor must be ductal carcinoma in situ (low or intermediate grade), invasive ductal carcinoma (any grade), or invasive lobular carcinoma.
  • Patients must have unicentric disease with limited or focal lymphovascular space invasion (LVSI).
  • Patients must have an estrogen reception (ER) analysis performed and the primary tumor should be ER positive.
  • The target partial mastectomy cavity must be clearly delineated and the target partial mastectomy cavity/whole breast reference volume must be ≤ 30% based on the post- operative scan. The partial mastectomy cavity must be > 5mm from the skin. This can be confirmed at time of CT simulation for radiation treatment planning.
  • Patients must enroll within 42 days following the last surgery for breast cancer (partial mastectomy or re-excision of margins).
  • Proton APBI should start within 12 weeks from the time of surgery.

Exclusion Criteria:

  • Male
  • Patients < 50 years of age.
  • Tumor > 3cm in greatest dimension or American Joint Committee on Cancer 8th edition pathologic stage T3 or T4 or node positive disease.
  • If patients have invasive carcinoma and no nodal assessment was performed, specifically the patient did not undergo sentinel lymph node biopsy or axillary lymph node dissection.
  • Patients with persistently positive margins despite attempted re-excision.
  • Proven multicentric disease or extensive LVSI.
  • Clear delineation of the extent of the target partial mastectomy cavity is not possible.
  • Patients who have undergone oncoplastic reconstruction.
  • Any patients who received neoadjuvant chemotherapy or hormonal therapy prior to surgical excision of the tumor.
  • Any patients who require adjuvant chemotherapy following lumpectomy.
  • Patients whose primary tumor is ER negative.
  • Patients with high grade ductal carcinoma in situ.
  • Patients with known BRCA1 or BRCA2 mutation.
  • Prior breast or thoracic radiation and any prior breast surgery in the ipsilateral breast.
  • Patients with history of collagen vascular disease including scleroderma, lupus, polymyositis, or dermatomyositis.
  • Pregnancy.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03940248
Other Study ID Numbers  ICMJE 2019-0088
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Teresa Meier, University of Cincinnati
Study Sponsor  ICMJE University of Cincinnati
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Cincinnati
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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