- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06826014
TREC@TAMU 암 예방 레지스트리 및 저장소
암의 텍사스 지역 우수성 (TREC) @Texas A & M University Cancer Prevention Registry and Repository
This study collects health and genetic information to implement cancer prevention and treatment strategies.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Kenneth S Ramos, MD
- 전화번호: 7136777740
- 이메일: kramos@tamu.edu
연구 연락처 백업
- 이름: Rick Silva, PhD
- 전화번호: (713) 677-7422
- 이메일: ricksilva@tamu.edu
연구 장소
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Texas
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Bryan, Texas, 미국, 77802
- 모병
- Texas A&M Family Care
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수석 연구원:
- Kenneth S Ramos, MD, PhD
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부수사관:
- Rick Silva, PhD
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부수사관:
- Fen Wang, PhD
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부수사관:
- Marcia Ory, PhD
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연락하다:
- De Lona A Bacote, MS
- 전화번호: 7136777735
- 이메일: dabacote@tamu.edu
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연락하다:
- Gabriel Neal, MD
- 전화번호: 9794360399
- 이메일: gneal@tamu.edu
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: OTHER
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Frequency and nature of ADRs on the Naranjo Scale Questionnaire
기간: 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. |
5 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Self-reported Health status and any significant changes
기간: 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. |
5 years
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .