암 가족력이 강한 환자의 암 조기 발견을 위한 전신자기공명영상 및 액체생검 분석
암 조기 발견을 위한 전신 MRI 및 액체 생검
This study evaluates patient acceptability of whole body magnetic resonance imaging (WBM) and liquid biopsies (LB) in detecting early stage cancer in patients with a strong family history of cancer. Collecting family history and testing for genes passed on from parent to child (germline testing) can be used to predict the likelihood of a patient developing cancer. Currently, detection of early cancers focuses on screening specific organ systems such as breast and colon cancer. Magnetic resonance imaging (MRI) uses a large magnet and radio waves to look at organs and structures inside the body. Health care professionals use MRI scans to diagnose a variety of conditions, from torn ligaments to cancer. Liquid biopsy is test that analyzes blood samples to determine if cancer cells are present. This study may help researchers determine the feasibility of WBM and liquid biopsies to detect early stage cancer in patients that have a strong family history of cancer.
연구 개요
상태
상세 설명
PRIMARY OBJECTIVE:
I. To assess the acceptability of the approach of LB and WBM.
SECONDARY OBJECTIVES:
I. Determine the prevalence of WBM findings requiring additional imaging or invasive testing.
II. Determine the effect of germline testing, LB, and WBM on psychological distress and health-related quality of life (HR-QOL) at 6 months after testing compared with baseline.
EXPLORATORY OBJECTIVE:
I. Determine correlation between high-risk LB findings and cancer detected on WBM.
OUTLINE: This is an observational study.
Patients undergo WBM without contrast, blood sample collection for liquid biopsy, and complete surveys on study. Germline testing may also be performed on blood sample collected as standard of care or using the Precision Medicine protocol (Institutional Review Board [IRB] 96144).
연구 유형
등록 (실제)
단계
- 초기 1단계
연락처 및 위치
연구 장소
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-
California
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Duarte, California, 미국, 91010
- City of Hope Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age >= 50 years, or age within 10 years of first degree relative with cancer at age of diagnosis (as long as age is >= 18)
- Have a strong family history of cancer ( >= 2 first-degree relatives with cancer, one first and second degree relative with cancer in one lineage (side of family), or at least three first or second degree relatives with cancer in one lineage (side of the family). Non-melanoma skin cancer excluded from family history eligibility
- Have a family history of early-onset cancer (age >40) in at least one first-degree relative
- Willing to have 50 mL of blood (approximately 3.5 tablespoons) drawn (40 ml if germline testing already performed)
- Able to undergo MRI (no implants, metal, or claustrophobia that would preclude MRI)
- Any cancer diagnosis within past 5 years, excluding non-melanoma skin cancer
- Positron emission tomography/computed tomography (PET/CT) or other whole body imaging modality (including combination of CT chest and abdomen) within 3 years
- No signs/symptoms of possible cancer (e.g. hemoptysis, breast mass, blood per rectum, unexplained weight loss)
- Willing to undergo standard of care genetic counseling and germline testing, or has already undergone genetic counseling and germline testing
- Documented informed consent of the participant
Exclusion Criteria:
- Unable to provide informed consent
- Contraindications to MRI (implants, metal, or claustrophobia that would preclude MRI)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Whole Body MRI and Liquid Biopsy
Patients undergo WBM without contrast and blood sample collection for liquid biopsy |
Undergo blood sample collection
다른 이름들:
Complete surveys Undergo germline testing
다른 이름들:
Undergo liquid biopsy testing
다른 이름들:
Undergo whole body MRI without contrast
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Acceptability of germline testing, liquid biopsy and whole body magnetic resonance imaging (WBM)
기간: Up to 6 months after WBM
|
Acceptability, as measured by the survey question "How satisfied are you with the research study overall?" and is defined as a score of 4 ("moderately acceptable) or 5 ("highly acceptable"). |
Up to 6 months after WBM
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Prevalence of WBM findings requiring additional imaging or invasive testing
기간: Up to 6 months after WBM
|
Prevalence of WBM findings requiring additional imaging or invasive testing, described as a per participant percentage. |
Up to 6 months after WBM
|
|
Psychological distress (Germline testing)A
기간: Up to 6 months after WBM
|
The effect of germline testing on psychological distress, as measured by STAI survey composite score between baseline and 6 months after testing. |
Up to 6 months after WBM
|
|
Psychological distress (Germline testing)B
기간: Up to 6 months after WBM
|
The effect of germline testing on psychological distress, as measured by cancer worry scale survey scores between baseline and 6 months after testing. |
Up to 6 months after WBM
|
|
Psychological distress (Liquid Biopsy)A
기간: Up to 6 months after WBM
|
The effect of LB on psychological distress, as measured by STAI survey composite score between baseline and 6 months after testing. |
Up to 6 months after WBM
|
|
Psychological distress (Liquid Biopsy)B
기간: Up to 6 months after WBM
|
The effect of LB on psychological distress, as measured by cancer worry scale survey scores between baseline and 6 months after testing. |
Up to 6 months after WBM
|
|
Psychological distress (WBM)A
기간: Up to 6 months after WBM
|
The effect of Whole Body MRI on Psychological distress, as measured by STAI survey composite score between baseline and 6 months after testing. |
Up to 6 months after WBM
|
|
Psychological distress (WBM)B
기간: Up to 6 months after WBM
|
The effect of Whole Body MRI on Psychological distress, as measured by cancer worry scale survey scores between baseline and 6 months after testing. |
Up to 6 months after WBM
|
|
Health Related Quality of Life (HRQOL/Germline)
기간: Up to 6 months after WBM
|
The effect of germline testing on HRQOL, as measured by the change in SF12 survey composite score between baseline and 6 months after testing. |
Up to 6 months after WBM
|
|
Health Related Quality of Life (HRQOL/LB)
기간: Up to 6 months after WBM
|
The effect of LB on HRQOL, as measured by the change in SF12 survey composite score between baseline and 6 months after testing. |
Up to 6 months after WBM
|
|
Health Related Quality of Life (HRQOL/WBM)
기간: Up to 6 months after WBM
|
The effect of WBM on HRQOL, as measured by the change in SF12 survey composite score between baseline and 6 months after testing. |
Up to 6 months after WBM
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Correlation between high-risk liquid biopsy findings and cancer detected on WBM
기간: Up to 6 months after WBM
|
Liquid biopsy (LB) test sensitivity and specificity calculated by comparing the LB results with the WBM results, with WBM results considered the gold standard. Confusion matrix statistics, such as positive predictive value, negative predictive value, and test accuracy examined. Results reported with their corresponding 95% confidence intervals. |
Up to 6 months after WBM
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Dan Raz, City of Hope Medical Center
간행물 및 유용한 링크
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 21574
- P30CA033572 (미국 NIH 보조금/계약)
- 21574 (기타 식별자: City of Hope Medical Center)
- NCI-2022-01829 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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