Screening of Cancer Through Novel Female Specific Biomarkers
NCT ID: NCT03951428
Last Updated: 2019-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2019-05-15
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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All Participants
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* are either healthy or have a recent diagnosis of breast, endometrial or lung cancer and have not yet begun treatment (your doctor will provide the stage of cancer at time of enrollment)
* are willing and able to comply with the study requirements
* have a negative pregnancy test prior to enrolling in this study
* Have provided all current medication usage and accurately reported disease history (both current and past) and completed the health profile provided at time of enrollment
* currently menstruating
Exclusion Criteria
* have any active sexually transmitted diseases•if you become pregnant while on the study, you must withdraw from the study.
* have received an investigational drug within four weeks prior to the study or who plan to use other investigational drugs duringthis study.
* have severe medical condition(s) that in the view of the investigator prohibits participation in the study.
18 Years
FEMALE
Yes
Sponsors
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Baylor Scott and White Health
OTHER
LifeStory Health Inc.
INDUSTRY
Responsible Party
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Locations
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Vasicek Cancer Treatment Center
Temple, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LSHBSWMBC
Identifier Type: -
Identifier Source: org_study_id
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