Clinical trial · Observational
Tumor-Derived FGF19
Translational Utility of Tumor-Derived FGF19 in a Novel Blood-Based Endocrine Suppression Approach
NCT06068257CI-TRIAL-00119847completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Identify and test thresholds, specificity and sensitivity for a potential cancer associated biomarker protein, FGF19, (and associated markers) for detection in human blood in the blood of breast and colorectal in cancer patients, and see if occurs at higher rates than healthy controls
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Healthy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To Identify and test thresholds, specificity and sensitivity for FGF19, (and associated markers) for detection in human blood of breast and colorectal in cancer patients, and see if occurs at higher rates than healthy controls.
- timeFrame
- 1 year
- description
- The primary marker that the investigators will look for is FGF19, a factor of normally restricted spatially to parts of the intestine and gall bladder, especially following a meal. The investigators will test in cancer patients whether FGF19 (or other associated markers) are higher in the blood of subset of cancer patients. The investigator pose the question of whether FGF19 is actively secreted into blood by human tumors. In further examine its use as a blood biomarker, the investigators will address whether higher levels of FGF19 cutoffs can be detected in the blood of colorectal cancer or breast cancer patients over that of control participants. Successful completion of this goal will, for the first time, establish whether tumor production of FGF19 in human colorectal or breast tumors contributes to elevated levels in either, all or a subset of patients compared to blood levels in people without cancer.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.