Condition or disease | Intervention/treatment |
---|---|
Cancer | Diagnostic Test: Menstrual Blood Screening Test |
The sponsor will first analyze menstrual blood (MB) samples in three discreet studies: breast, endometrial, lung. According to American Institute for Cancer Research, "Endometrial cancer is the most common cancer of the female reproductive organs. More cases of endometrial cancer occur each year than ovarian and cervical cancers combined." 20% to 25% will be diagnosed with endometrial cancer before menopause. Based on the patient recruitment potential and high impact on women's health, these three cancer types are suitable models to evaluate the expediency of utilizing MB as an ideal source for identification of cancer markers.
Health profiles are completed by all participants and where applicable and possible, patient medical records, health tracking device data, etc. will be included. Blood samples will be collected as indicated on the collection protocol outlined by LifeStory Health's (LSH's) Protocol and Instructions for Use. Samples will be collected in the participant's home according to LSH's Collection Protocol using EBF-Inc.'s 903 dried blood spot (DBS) collection device prior shipment to the research center. Samples should be sent within 3 days of collection. Up to one-hundred and fifty micro-liters (150 uL) of menstrual blood can be collected from donors using the collection device.Samples will be processed according to LSH's protocol and any methods outlined in this development plan.
The study will receive samples from 60 female participants, totaling 30 samples from early-stage cancer patients and 30 samples from healthy women. After initial determination of potential cancer markers for all three cancer types, the sponsor will select a single cancer type with the most promising results ("Cancer 1") and carry out additional, statistically higher-powered, studies on all four stages of this selected cancer. After the identities of potential MB biomarkers for a single cancer type are re-confirmed and established at the highest level of confidence, simple assays will be developed for cost-effective detection of target proteoforms for early detection of cancer.
Overall conduct of the study is the responsibility of the recruiting facilities/physicians. LifeStory Health provides operational oversight. The Baylor Scott and White Research Division (BSW) is responsible for oversight of the Regional Centers. LifeStory Health is responsible for data collection,management and analysis. Study patient safety and study performance are monitored by BSW. This study is being conducted with LifeStory Health and principal investigator, Anna Villarreal, CEO and Founder of LifeStory Health Inc.This randomized, double blind, controlled trial will enroll 60 patients.
Study Type : | Observational |
Estimated Enrollment : | 60 participants |
Observational Model: | Case-Control |
Time Perspective: | Retrospective |
Official Title: | Screening and Early Detection of Cancer Through Identification of Novel Female Specific Biomarkers Through Self-Collected Menstrual Blood |
Estimated Study Start Date : | May 15, 2019 |
Estimated Primary Completion Date : | November 1, 2019 |
Estimated Study Completion Date : | December 31, 2019 |
Group/Cohort | Intervention/treatment |
---|---|
All Participants |
Diagnostic Test: Menstrual Blood Screening Test
The sponsor will be testing women's menstrual blood to investigate the feasibility and efficacy of assessing three early stage cancers via self-collected menstrual blood using FDA approved devices.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Three sites will serve as participant recruitment:
Baylor Scott & White Medical Center - Hillcrest Baylor Scott & White Medical Center - Round Rock Scott & White Medical Center - Temple
Inclusion Criteria:
are 18 years or older
Exclusion Criteria:
Contact: Anna Villarreal, JD | 512-660-8201 | anna@annavillahealth.com | |
Contact: Dedra Preece, BS, CCRP | 254-724-5939 | Dedra.Preece@BSWHealth.org |
United States, Texas | |
Vasicek Cancer Treatment Center | Recruiting |
Temple, Texas, United States, 76508 | |
Contact: Dedra Preece, BS, CCRP 254-724-5939 Dedra.Preece@BSWHealth.org |
Tracking Information | |||||||
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First Submitted Date | May 13, 2019 | ||||||
First Posted Date | May 15, 2019 | ||||||
Last Update Posted Date | May 15, 2019 | ||||||
Estimated Study Start Date | May 15, 2019 | ||||||
Estimated Primary Completion Date | November 1, 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
Use UPLC UHR-MS and UPLC IM-MS to confirm previous findings of unique signatures in menstrual blood. The sponsor will additionally measure and new biomarkers in menstrual blood for early detection of breast, endometrial, and lung cancers. [ Time Frame: 8 weeks ] UHR-MS and IM-MS, in parallel, for proteomics analysis of MB. These two approaches offer complementary advantages for comprehensive proteomic studies and assure detection of low abundance and post-translationally modified proteins in complex mixtures.
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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 | Screening of Cancer Through Novel Female Specific Biomarkers | ||||||
Official Title | Screening and Early Detection of Cancer Through Identification of Novel Female Specific Biomarkers Through Self-Collected Menstrual Blood | ||||||
Brief Summary | Can reliable biomarkers be identified for detection of cancer at early stages using menstrual blood (MB)? Preliminary mass spectrometry (MS) results suggest that MB provides biomarkers for identification of disease such as cancers. | ||||||
Detailed Description |
The sponsor will first analyze menstrual blood (MB) samples in three discreet studies: breast, endometrial, lung. According to American Institute for Cancer Research, "Endometrial cancer is the most common cancer of the female reproductive organs. More cases of endometrial cancer occur each year than ovarian and cervical cancers combined." 20% to 25% will be diagnosed with endometrial cancer before menopause. Based on the patient recruitment potential and high impact on women's health, these three cancer types are suitable models to evaluate the expediency of utilizing MB as an ideal source for identification of cancer markers. Health profiles are completed by all participants and where applicable and possible, patient medical records, health tracking device data, etc. will be included. Blood samples will be collected as indicated on the collection protocol outlined by LifeStory Health's (LSH's) Protocol and Instructions for Use. Samples will be collected in the participant's home according to LSH's Collection Protocol using EBF-Inc.'s 903 dried blood spot (DBS) collection device prior shipment to the research center. Samples should be sent within 3 days of collection. Up to one-hundred and fifty micro-liters (150 uL) of menstrual blood can be collected from donors using the collection device.Samples will be processed according to LSH's protocol and any methods outlined in this development plan. The study will receive samples from 60 female participants, totaling 30 samples from early-stage cancer patients and 30 samples from healthy women. After initial determination of potential cancer markers for all three cancer types, the sponsor will select a single cancer type with the most promising results ("Cancer 1") and carry out additional, statistically higher-powered, studies on all four stages of this selected cancer. After the identities of potential MB biomarkers for a single cancer type are re-confirmed and established at the highest level of confidence, simple assays will be developed for cost-effective detection of target proteoforms for early detection of cancer. Overall conduct of the study is the responsibility of the recruiting facilities/physicians. LifeStory Health provides operational oversight. The Baylor Scott and White Research Division (BSW) is responsible for oversight of the Regional Centers. LifeStory Health is responsible for data collection,management and analysis. Study patient safety and study performance are monitored by BSW. This study is being conducted with LifeStory Health and principal investigator, Anna Villarreal, CEO and Founder of LifeStory Health Inc.This randomized, double blind, controlled trial will enroll 60 patients. |
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Study Type | Observational | ||||||
Study Design | Observational Model: Case-Control Time Perspective: Retrospective |
||||||
Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
Sampling Method | Non-Probability Sample | ||||||
Study Population |
Three sites will serve as participant recruitment: Baylor Scott & White Medical Center - Hillcrest Baylor Scott & White Medical Center - Round Rock Scott & White Medical Center - Temple |
||||||
Condition | Cancer | ||||||
Intervention | Diagnostic Test: Menstrual Blood Screening Test
The sponsor will be testing women's menstrual blood to investigate the feasibility and efficacy of assessing three early stage cancers via self-collected menstrual blood using FDA approved devices.
|
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Study Groups/Cohorts | All Participants
Intervention: Diagnostic Test: Menstrual Blood Screening Test
|
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Unknown status | ||||||
Estimated Enrollment |
60 | ||||||
Original Estimated Enrollment | Same as current | ||||||
Estimated Study Completion Date | December 31, 2019 | ||||||
Estimated Primary Completion Date | November 1, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | Yes | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT03951428 | ||||||
Other Study ID Numbers | LSHBSWMBC | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | LifeStory Health Inc. | ||||||
Study Sponsor | LifeStory Health Inc. | ||||||
Collaborators | Baylor Scott and White Health | ||||||
Investigators | Not Provided | ||||||
PRS Account | LifeStory Health Inc. | ||||||
Verification Date | May 2019 |