Samples Procurement for Colorectal Cancer, Gastric Cancer, and Non-malignant Disease

April 28, 2022 updated by: Tao Fu, Renmin Hospital of Wuhan University

Samples Procurement for Patients With Colorectal Cancer, Gastric Cancer, and Non-malignant Disease Undergoing Surgery

The purposes of this study are to collect and store samples including blood, normal and tumor tissue from patients with colorectal cancer or gastric cancer, to collect and store samples including blood and/or normal gastrointestinal tissue (if available) from patients with non-malignant disease (including, but not limited to, inflammatory bowel disease (IBD), gastric ulcer, hemorrhoids or hernia), and to create a database for the collected samples and allow access to relevant clinical information for current and future protocols.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Recruiting
        • Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants who are planning to undergo surgery.

Description

Inclusion Criteria:

  • Any patient diagnosed with colorectal cancer, gastric cancer, non-malignant disease that requires undergoing surgery.
  • Must be willing and able to provide informed consent.

Exclusion Criteria:

  • Subjects whose comorbidities would preclude diagnostic or therapeutic intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Colorectal cancer or gastric cancer patient
Patients suffering from CRC or gastric cancer scheduled to have surgical resection of colon/rectum or stomach.
Other: No intervention will be given to patients.
Samples are collected at the time of a scheduled surgery that is part of normal treatment. This study will not have any impact on the care or treatment the patient receives.
Non-malignant disease patient
Patients suffering from non-malignant disease scheduled to have surgery.
Other: No intervention will be given to patients.
Samples are collected at the time of a scheduled surgery that is part of normal treatment. This study will not have any impact on the care or treatment the patient receives.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confirmation of diagnosis by pathologist
Time Frame: Up to 3 years
Once tissue is collected, those samples that have a confirmed diagnosis of disease by the pathologist will be used.
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Renmin Hospital of Wuhan University

Investigators

  • Principal Investigator: Tao Fu, MD, Renmin Hospital of Wuhan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2020

Primary Completion (Anticipated)

December 23, 2023

Study Completion (Anticipated)

December 23, 2026

Study Registration Dates

First Submitted

May 30, 2019

First Submitted That Met QC Criteria

May 31, 2019

First Posted (Actual)

June 4, 2019

Study Record Updates

Last Update Posted (Actual)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 28, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAMPGICUS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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