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Recruiting

NCT Number: NCT06826014

TREC@TAMU Cancer Prevention Registry and Repository

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

Recruiting

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Key information

Conditions

Cancer Diet Disease Genetics Lifestyle Factors Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Texas A&M Family Care

Bryan, Texas, 77802, United States

Location status: Recruiting

Location contact

De Lona A Bacote, MS

CONTACT

[email protected]

7136777735

Fen Wang, PhD

SUB_INVESTIGATOR

Gabriel Neal, MD

CONTACT

[email protected]

979-436-0399

Kenneth S Ramos, MD, PhD

PRINCIPAL_INVESTIGATOR

Marcia Ory, PhD

SUB_INVESTIGATOR

Rick Silva, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Frequency and nature of ADRs on the Naranjo Scale Questionnaire

    Time frame: 5 years

    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.

Secondary outcomes

  1. Self-reported Health status and any significant changes

    Time frame: 5 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kenneth S Ramos, MD

CONTACT

[email protected]

7136777740

Rick Silva, PhD

CONTACT

[email protected]

(713) 677-7422

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Feb 13, 2025
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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