NCT03998644

Brief Summary

Recruit of healthy, precancer and colorectal cancer patients and record necessary information of demographic and also other messages. All the volunteers were asked to provide samples including stool, blood, urine and tissues. This protocol is performed with the permission of the ethics committee and all the participants were provided with informed consent.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2016

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

June 26, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 2, 2019

Status Verified

June 1, 2019

Enrollment Period

5 years

First QC Date

December 26, 2016

Last Update Submit

June 30, 2019

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Gut microbiota structure and function difference between colorectal cancer, precancer and healthy controls

    The results were based on the 16S rRNA metagenomic sequencing.

    average of 5 years

Secondary Outcomes (1)

  • Metabolic difference of blood samples between colorectal cancer, precancer and healthy controls

    average of 5 years

Study Arms (3)

healthy

Subjects without colorectal disorders.

precancerous

Subjects with risk factors that may contribute to the carcinogenesis.

colorectal cancer

Patients who were identified by standard procedures to suffer with colorectal cancer.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Three different groups were created by healthy volunteers, precancerous and colorectal cancer patients. The information of these individuals will be analyzed and some conclusions will be drawn.

You may qualify if:

  • individuals who were clear and signed the informed consent.
  • Male and female.
  • Age \>18

You may not qualify if:

  • Any one who can not provide accurate information.
  • Any one who denies the study.
  • Younger than 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Huanlong Qin, Ph.D

CONTACT

86-021-66301161huanlqin@126.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 26, 2016

First Posted

June 26, 2019

Study Start

December 1, 2015

Primary Completion

December 1, 2020

Study Completion

December 1, 2025

Last Updated

July 2, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)