TREC@TAMU Cancer Prevention Registry and Repository

Texas Regional Excellence in Cancer (TREC) @Texas A&M University Cancer Prevention Registry and Repository

This study collects health and genetic information to implement cancer prevention and treatment strategies.

Study Overview

• Status: Recruiting
• Conditions: Disease; Cancer; Genetics; Diet; Lifestyle Factors

Detailed Description

This research will explore how genetics, diet, exercise, and jobs influence the risk of developing cancers that can be treated early. The goal is to find out if this knowledge can help doctors and health insurers improve their methods for preventing cancers that cannot be treated.

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Kenneth S Ramos, MD; Phone Number: 7136777740; Email: kramos@tamu.edu
• Study Contact Backup: Name: Rick Silva, PhD; Phone Number: (713) 677-7422; Email: ricksilva@tamu.edu

Study Locations

• United States
  • Texas
    • Bryan, Texas, United States, 77802
      • Recruiting
      • Texas A&M Family Care
      • Contact: Gabriel Neal, MD; Phone Number: 979-436-0399; Email: gneal@tamu.edu
      • Principal Investigator: Kenneth S Ramos, MD, PhD
      • Sub-Investigator: Rick Silva, PhD
      • Sub-Investigator: Fen Wang, PhD
      • Sub-Investigator: Marcia Ory, PhD
      • Contact: De Lona A Bacote, MS; Phone Number: 7136777735; Email: dabacote@tamu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

TREC@TAMU Registry will recruit as many participants as possible. The estimated enrollment in five years is expected to be 2500, but investigators will not limit recruitment if that number is exceeded.

Description

Inclusion Criteria:

• 18 years of age and older, and,
• People participating in the Cancer Prevention and Research Institute of Texas (CPRIT) A coordinated cancer screening research program in Bryan and Navasota Family Medicine Clinics and,
• People with COPD, liver disease, cervical intraepithelial neoplasia (CIN) lesions, having had a colonoscopy or a low dose computed tomography (LDCT) lung scan or cervical exam in the last 12 months or scheduled for one, and,
• Able to give and comprehend the consent process, and,
• Able to consent to donate blood and urine samples, genetic material through buccal swabs for future research, and,
• Able to understand that their specimens, health record, and changes in health status will be followed for a five-year period and shared in deidentified form with the research community, and,
• All sexes and gender identities.

Exclusion Criteria:

• Declines to participate or interact with staff/share their medical status.
• A diagnosis of Alzheimer's disease or related dementias in a medical record indicates a progressive, debilitating condition that impairs memory, thought processes, and functioning Individuals who are unable or unwilling to provide consent will be excluded

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and nature of ADRs on the Naranjo Scale Questionnaire	Measure the frequency and nature of adverse drug reactions by obtaining a complete medical history and physical examination and validating the patient's current concomitant medication list during the office visit. Patient medical information would be input into the ActX platform, which functions as a computable EHR medical record analysis, evaluation of polypharmacy status, and monitoring of ADRs using the Naranjo Scale will be conducted for the duration of the study.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Health status and any significant changes	The EQ-5D-5L survey, designed to collect data on health status and significant changes, will be administered to every patient in the registry at each clinic visit and at least every six months for five years after enrollment. The EQ-5D-5L consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension features five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Patients indicate their health state by ticking the box next to the most appropriate statement for each dimension. This choice generates a one-digit number representing the selected level for that dimension. The numbers from the five dimensions can be combined into a five-digit number that characterizes the patient's health state.	5 years

Collaborators and Investigators

• Sponsor: Texas A&M University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2030

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: genetics; cancer
• Other Study ID Numbers: STUDY2024-0008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No