Pathogenic Mechanisms of Cancer and Cardiovascular Diseases

NCT03051191 | Completed

• 1 other identifier: SHIP02
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

Subjects with cardiovascular diseases (CVD) have higher incidence of cancers compared to general population. The investigators hypothesized that shared molecular mechanism play a pivotal role in the pathogenesis of CVD including heart failure (HF) and cancers. To address this hypothesis, the investigators are going to explore the expression pattern of micro RNA (miRNA) and cell free DNA (cfDNA) derived from host, gut microbiota and gut microbiota composition extensively in patients with or without CVD, non-ischemic HF (NIHF), and cancers. The participants will be recruited from the outpatient clinic in Sakakibara Heart Institute or Japanese Foundation for Cancer Research. By comparing the expression pattern of miRNA, cfDNA, or gut microbiota composition, the investigators are seeking to find the pathogenic mechanisms shared by those diseases.

Conditions

Pathogenesis; Cardiovascular Diseases; Cancer

Keywords

atherosclerotic cardiovascular diseases; nonischemic heart failure; cancer

Outcome Measures

Primary Outcomes (4)

• miRNA

  Expression pattern of miRNA in blood

  At enrollment

• Cell free DNA from host

  Quantity of cell free DNA derived from host in blood

  At enrollment

• Cell free DNA from microbiota

  Expression pattern of cell free DNA distinct from microbiota in blood

  At enrollment

• bacterial composition in stool

  the bacterial composition analyzed by shot gun analysis of 16s rRNA genes in stool

  At enrollment

Study Arms (6)

1: No ACVD/NIHF or cancers

The patients who do not have ACVD, NIHF or cancers

Diagnostic Test: micro RNA

2: Cancers but no ACVD/NIHF

The patients who have cancers but no ACVD/NIHF

Diagnostic Test: micro RNA

3: ACVD and cancers

The patients who have ACVD and cancers

Diagnostic Test: micro RNA

4: ACVD but no cancers

The patients who have ACVD but no cancers

Diagnostic Test: micro RNA

5: NIHF and cancers

The patients who have NIHF and cancers

Diagnostic Test: micro RNA

6: NIHF but no cancers

The patients who have NIHF but no cancers

Diagnostic Test: micro RNA

Interventions

micro RNA DIAGNOSTIC_TEST

micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.

Also known as: cell free DNA, 16S rRNA genes of gut microbiota

1: No ACVD/NIHF or cancers; 2: Cancers but no ACVD/NIHF; 3: ACVD and cancers; 4: ACVD but no cancers; 5: NIHF and cancers; 6: NIHF but no cancers

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects who regularly visit outpatient clinic in Sakakibara Heart Institute or The Cancer Institute Hospital of Japanese Foundation of Cancer Research.

You may qualify if:

• subjects who regularly visit outpatient clinic in Sakakibara Heart Institute or The Cancer Institute Hospital of Japanese Foundation of Cancer Research.

You may not qualify if:

• subjects who have multiple cancers

Sponsors & Collaborators

• Sakakibara Heart Institute: lead
• Japanese Foundation for Cancer Research: collaborator

Study Sites (2)

Sakakibara Heart Institute

Fuchū, 183-0003, Japan

Location

The Cancer Institute Hospital for Japanese Foundation for Cancer Research

Tokyo, 135-8550, Japan

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma containing cell free DNA

MeSH Terms

Conditions

Cardiovascular Diseases; Neoplasms

Interventions

Noninvasive Prenatal Testing

Intervention Hierarchy (Ancestors)

Liquid Biopsy; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Genetic Testing; Specimen Handling; Prenatal Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Tsutomu Yoshikawa

  Sakakibara Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 13, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 22, 2020

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)