Screening of Cancer Through Novel Female Specific Biomarkers

NCT03951428 | Unknown DMC FDA Device

• 1 other identifier: LSHBSWMBC
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  8 weeks

Study Arms (1)

All Participants

Diagnostic Test: Menstrual Blood Screening Test

Interventions

Menstrual Blood Screening Test DIAGNOSTIC_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.

All Participants

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• are 18 years or older
• 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

You may not qualify if:

• have a generalized infection (bacterial, viral or fungal), or obvious localized infections in the vaginal area
• 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.

Sponsors & Collaborators

• LifeStory Health Inc.: lead
• Baylor Scott and White Health: collaborator

Study Sites (1)

Vasicek Cancer Treatment Center

Temple, Texas, 76508, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Anna Villarreal, JD

CONTACT

512-660-8201; anna@annavillahealth.com

Dedra Preece, BS, CCRP

CONTACT

254-724-5939; Dedra.Preece@BSWHealth.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 15, 2019
• Study Start: May 15, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 31, 2019
• Last Updated: May 15, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)