Screening of Cancer Through Novel Female Specific Biomarkers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03951428|
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
|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|
|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|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951428
|Contact: Anna Villarreal, JDfirstname.lastname@example.org|
|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|