Cancer Clinical Trial
Official title:
Screening and Early Detection of Cancer Through Identification of Novel Female Specific Biomarkers Through Self-Collected Menstrual Blood
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.
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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