Tumor-Derived FGF19

NCT06068257 | Completed

• 1 other identifier: STUDY00005156
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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

Colorectal Cancer; Breast Cancer; Healthy

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants currently diagnosed with breast cancer and colorectal cancer, as well as, healthy participants who are currently cancer-free.

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Central Florida: lead

Study Sites (1)

Burnett School Biomedical Sciences

Orlando, Florida, 32816, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

This study collects blood from breast cancer patients, colorectal patients, and healthy (no cancer) controls to identify biomarkers.

MeSH Terms

Conditions

Colorectal Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Deborah Altomare, PhD

  University of Central Florida College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: October 5, 2023
• Study Start: June 6, 2023
• Primary Completion: June 4, 2026
• Study Completion: July 1, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

US (1)