NCT02845973

Brief Summary

The aim of the study is to identify and verify one or more gut bacteria of which the abundance in feces may help to early diagnosis colorectal cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,325

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

5.4 years

First QC Date

July 17, 2016

Last Update Submit

November 24, 2019

Conditions

Colorectal Neoplasms

Keywords

gut microbiota

Outcome Measures

Primary Outcomes (1)

  • differences in abundance of gut microbiota

    differences in abundance of gut microbiota for participants with different clinical outcomes confirmed by qPCR(quantitive polymerase chain reaction)

    1 year

Secondary Outcomes (1)

  • evidence of colorectal neoplasia

    1 year

Other Outcomes (1)

  • diet difference in patients with different clinical outcomes

    1 year

Study Arms (2)

test cohort

The test cohort was from Fudan University Shanghai Cancer Center (August 2016 to December 2016) and ECRJ-East Campus of Renji hospital (January 2012 to March 2017);

Biological: gut microbiota

validation cohort

The validation cohort was from Shanghai Tenth People's Hospital (October 2015 to November 2016) and WCRJ-West Campus of Renji hospital (July 2016 to March 2017)

Biological: gut microbiota

Interventions

gut microbiotaBIOLOGICAL
test cohortvalidation cohort

Eligibility Criteria

Age40 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chinese people

You may qualify if:

  • Patients age from 40 to 85 years old
  • Patients with endoscopic or pathological confirmed healthy, adenoma, inflammation, early or late stage of colorectal cancer
  • Patients with valid CEA(carcino embryonic antigen) and OB(occult blood) test result in 1 year before or after the coloscopy or surgery

You may not qualify if:

  • Patients with history of colorectal cancer
  • Patients with long term use of antibiotics or probiotics
  • Patients with uncontrolled diabetes, hypertension or hepatitis
  • Patients with a history of subtotal gastrectomy or partial bowel resection
  • Patients who are not able to cooperate
  • Patients with medical conditions who are not appropriate to participate the study
  • Patients who are taking aspirin, NSAIDs (nonsteroidal antiinflammatory drugs), COX2(cyclo-oxygen-ase 2) inhibitors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Institute of Digestive Disease

Shanghai, 200001, China

Location

Related Publications (1)

  • Xie YH, Gao QY, Cai GX, Sun XM, Sun XM, Zou TH, Chen HM, Yu SY, Qiu YW, Gu WQ, Chen XY, Cui Y, Sun D, Liu ZJ, Cai SJ, Xu J, Chen YX, Fang JY. Fecal Clostridium symbiosum for Noninvasive Detection of Early and Advanced Colorectal Cancer: Test and Validation Studies. EBioMedicine. 2017 Nov;25:32-40. doi: 10.1016/j.ebiom.2017.10.005. Epub 2017 Oct 4.

    PMID: 29033369RESULT

Biospecimen

Retention: SAMPLES WITH DNA

feces of participants

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Gastrointestinal Microbiome

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

MicrobiotaMicrobiological PhenomenaBiotaBiodiversityEcosystemEnvironmentEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Gastroenterology and Hepatology

Study Record Dates

First Submitted

July 17, 2016

First Posted

July 27, 2016

Study Start

January 1, 2012

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

November 26, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)