Testing a blood test for detecting colorectal and breast cancer
Translational Utility of Tumor-Derived FGF19 in a Novel Blood-Based Endocrine Suppression Approach
This study is testing a blood test that looks for a specific marker to see if it can help detect colorectal and breast cancer earlier and make screening easier for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Central Florida Academic / other |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT06068257 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify and evaluate the effectiveness of FGF19, a potential cancer biomarker, in detecting colorectal and breast cancer through blood samples. The research focuses on establishing thresholds, specificity, and sensitivity of FGF19 levels in cancer patients compared to healthy controls. By developing a blood-based test, the study seeks to provide a more convenient and accessible screening option for patients who may not participate in traditional screening methods like colonoscopy or mammograms. The ultimate goal is to improve early cancer detection and reduce mortality rates associated with late-stage diagnoses.
Who should consider this trial
Good fit: Ideal candidates include adults with breast cancer, colorectal cancer, or healthy individuals who can undergo a fasting blood draw.
Not a fit: Patients who are unable or unwilling to provide informed consent, as well as those who are not adults or are prisoners, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a reliable blood test that enhances early detection of colorectal and breast cancer, potentially saving lives.
How similar studies have performed: While blood-based cancer detection tests are still largely untested, the study builds on promising preliminary findings regarding FGF19 in animal models, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The study will enroll adult persons with breast cancer or colorectal cancer or no cancer (healthy controls) who are able to do a fasting blood draw. (Pregnant women may choose to be in the study. The study procedures do not pose a risk to the safety of the unborn child or the woman.) Exclusion Criteria: * The study will not enroll persons who are unable or unwilling to provide informed consent. * Adults unable to consent, individuals who are not yet adults, and prisoners will be excluded from this study.
Where this trial is running
Orlando, Florida
- Burnett School Biomedical Sciences — Orlando, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Deborah Altomare, PhD — University of Central Florida College of Medicine
- Study coordinator: Amoy Fraser, PhD, CCRP, PMP
- Email: amoy.fraser@ucf.edu
- Phone: 407-266-8742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.