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出境医 / 临床实验 / Clinical Application of ctDNA in Early Screening of Breast Cancer

Clinical Application of ctDNA in Early Screening of Breast Cancer

Study Description
Brief Summary:
The investigators aim to evaluate the possibility of clinical application of ctDNA detection in peripheral blood of normal people, benign breast disease patients and breast cancer patients, so as to act as the new techniques or indicators of early screening of breast cancer.

Condition or disease Intervention/treatment
Breast Cancer Diagnostic Test: Low depth whole genome sequencing

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Application of ctDNA in Early Screening of Breast Cancer
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2021
Arms and Interventions
Group/Cohort Intervention/treatment
Normal people Diagnostic Test: Low depth whole genome sequencing
Low depth whole genome sequencing of the peripheral blood samples from different groups.

Benign breast disease patients Diagnostic Test: Low depth whole genome sequencing
Low depth whole genome sequencing of the peripheral blood samples from different groups.

Breast cancer patients in early stage Diagnostic Test: Low depth whole genome sequencing
Low depth whole genome sequencing of the peripheral blood samples from different groups.

Outcome Measures
Primary Outcome Measures :
  1. ctDNA test model for early screening of breast cancer [ Time Frame: 2 years ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Three groups: normal people, benign breast disease patients and breast cancer patients in early stage.
Criteria

Inclusion Criteria:

  • Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.
  • Age of at least 18 and at most 70 years.
  • Normal people who works as the volunteers.
  • Benign breast disease patients should be diagnosed with confirmed pathology after surgery.
  • Breast cancer patients should be diagnosed with confirmed pathology after surgery, and with no clinical evidence of local recurrence or distant metastases. Complete staging work-up within 3 months prior to registration, which should be earlier than TNM IIA stage.
  • Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.

Exclusion Criteria:

  • Known hypersensitivity reaction to the investigational compounds or incorporated substances.
  • Local recurrence and/or metastasis of breast cancer.
  • Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration.
  • Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix).
  • Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study.
  • Concurrent treatment with other experimental drugs or any other anti-cancer therapy.
  • Males.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Yidong Zhou, Doctor 86-10-69155200 zhouyd@pumch.cn
Contact: Ru Yao, Doctor 86-10-69152001 yaoru@pumch.cn

Sponsors and Collaborators
Peking Union Medical College Hospital
Tracking Information
First Submitted Date June 2, 2019
First Posted Date June 4, 2019
Last Update Posted Date June 4, 2019
Estimated Study Start Date June 1, 2019
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 2, 2019)
ctDNA test model for early screening of breast cancer [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Application of ctDNA in Early Screening of Breast Cancer
Official Title Clinical Application of ctDNA in Early Screening of Breast Cancer
Brief Summary The investigators aim to evaluate the possibility of clinical application of ctDNA detection in peripheral blood of normal people, benign breast disease patients and breast cancer patients, so as to act as the new techniques or indicators of early screening of breast cancer.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Three groups: normal people, benign breast disease patients and breast cancer patients in early stage.
Condition Breast Cancer
Intervention Diagnostic Test: Low depth whole genome sequencing
Low depth whole genome sequencing of the peripheral blood samples from different groups.
Study Groups/Cohorts
  • Normal people
    Intervention: Diagnostic Test: Low depth whole genome sequencing
  • Benign breast disease patients
    Intervention: Diagnostic Test: Low depth whole genome sequencing
  • Breast cancer patients in early stage
    Intervention: Diagnostic Test: Low depth whole genome sequencing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 2, 2019)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 1, 2021
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.
  • Age of at least 18 and at most 70 years.
  • Normal people who works as the volunteers.
  • Benign breast disease patients should be diagnosed with confirmed pathology after surgery.
  • Breast cancer patients should be diagnosed with confirmed pathology after surgery, and with no clinical evidence of local recurrence or distant metastases. Complete staging work-up within 3 months prior to registration, which should be earlier than TNM IIA stage.
  • Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.

Exclusion Criteria:

  • Known hypersensitivity reaction to the investigational compounds or incorporated substances.
  • Local recurrence and/or metastasis of breast cancer.
  • Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration.
  • Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix).
  • Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study.
  • Concurrent treatment with other experimental drugs or any other anti-cancer therapy.
  • Males.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03973034
Other Study ID Numbers PUMCH-BREAST-ctDNA screening
Has Data Monitoring Committee Not Provided
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 Not Provided
Responsible Party Peking Union Medical College Hospital
Study Sponsor Peking Union Medical College Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Peking Union Medical College Hospital
Verification Date June 2019

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