Cancer Clinical Trial
Official title:
Screening and Early Detection of Cancer Through Identification of Novel Female Specific Biomarkers Through Self-Collected Menstrual Blood
NCT number | NCT03951428 |
Other study ID # | LSHBSWMBC |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 15, 2019 |
Est. completion date | December 31, 2019 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2019 |
Est. primary completion date | November 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Vasicek Cancer Treatment Center | Temple | Texas |
Lead Sponsor | Collaborator |
---|---|
LifeStory Health Inc. | Baylor Scott and White Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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