- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03051191
Pathogenic Mechanisms of Cancer and Cardiovascular Diseases
Exploring the Pathogenic Mechanisms Shared by Cancer and Cardiovasuclar Diseases
연구 개요
상세 설명
It has been reported that subjects with cardiovascular diseases (CVD) have higher incidence of cancers compared with general population. Because of the genetic and traditional commonalities between the underlying causes of CVD and cancers, the investigators hypothesized that shared molecular mechanism play a pivotal role in the pathogenesis of CVD including heart failure (HF) and cancers.
MicroRNAs (miRNAs) are small, single-stranded non-coding RNA sequences of about 18-22 nucleotides that interact with specific target messenger RNAs. They are known to be involved in the various processes including development, homeostasis, cell differentiation, proliferation, apoptosis and various diseases by modulating post-transcriptional and translational processes. Some of miRNAs have been reported to be involved in the pathogenesis of cancers. Cell free DNAs (cfDNA) is extracellular nucleic acids found in cell-free plasma in humans. Elevated level of cfDNA was reported in patients with cancer and CVD. 16S ribosomal RNA (rRNA) genes are distinct in microbiota, which can be utilized to quantify the bacterial DNA in the systemic circulation. 16S rRNA genes are also shown to be elevated in patients with CVD. These findings imply the possibility that translocated microbiota might play pivotal roles in the pathogenesis of CVD and cancers. The quantity and composition of gut microbiota have been shown to be altered in various diseases including obesity, diabetes mellitus, hypertension and CVD. The previous findings from fecal transplantation experiments, which showed the disease phenotype was transferred from one to another subject (animal or human), strongly suggest the possibility that microbiota play some pathogenic roles in those diseases.
To address this hypothesis, the investigators are going to cross-sectionally explore the expression pattern of miRNA and cfDNA and the composition of gut microbiota extensively in patients with or without atherosclerotic CVD (ACVD), non-ischemic HF (NIHF), and cancers. The investigators will recruit the participants from the patients who regularly visit the outpatient clinic in Sakakibara Heart Institute or The Cancer Institute Hospital of Japanese Foundation of Cancer Research. The investigators will recruit the patients without ACVD or NIHF and with/without cancers (Group 1/2), those with ACVD and with/without cancers (Group 3/4), and those with NIHF and with/without cancers (Group 5/6). Their peripheral blood will be drawn and stools will be collected. miRNA in exosome will be extracted from plasma and explored by miRNA microarray. cfDNA pattern will be extensively explored by microarray. By comparing the expression pattern of miRNA and cfDNA, and the composition of gut microbiota by 16s rRNA gene shotgun analysis, the investigators will be seeking to find the molecular mechanisms shared by those diseases.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Fuchu, 일본, 183-0003
- Sakakibara Heart Institute
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Tokyo, 일본, 135-8550
- The Cancer Institute Hospital for Japanese Foundation for Cancer Research
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- subjects who regularly visit outpatient clinic in Sakakibara Heart Institute or The Cancer Institute Hospital of Japanese Foundation of Cancer Research.
Exclusion Criteria:
- subjects who have multiple cancers
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 단면
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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1: No ACVD/NIHF or cancers
The patients who do not have ACVD, NIHF or cancers
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micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
다른 이름들:
|
|
2: Cancers but no ACVD/NIHF
The patients who have cancers but no ACVD/NIHF
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micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
다른 이름들:
|
|
3: ACVD and cancers
The patients who have ACVD and cancers
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micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
다른 이름들:
|
|
4: ACVD but no cancers
The patients who have ACVD but no cancers
|
micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
다른 이름들:
|
|
5: NIHF and cancers
The patients who have NIHF and cancers
|
micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
다른 이름들:
|
|
6: NIHF but no cancers
The patients who have NIHF but no cancers
|
micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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miRNA
기간: At enrollment
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Expression pattern of miRNA in blood
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At enrollment
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Cell free DNA from host
기간: At enrollment
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Quantity of cell free DNA derived from host in blood
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At enrollment
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Cell free DNA from microbiota
기간: At enrollment
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Expression pattern of cell free DNA distinct from microbiota in blood
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At enrollment
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bacterial composition in stool
기간: At enrollment
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the bacterial composition analyzed by shot gun analysis of 16s rRNA genes in stool
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At enrollment
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공동 작업자 및 조사자
수사관
- 수석 연구원: Tsutomu Yoshikawa, Sakakibara Heart Institute
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
- SHIP02
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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