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

NCT03972956 | Recruiting

• 1 other identifier: SAMPGICUS
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer; Gastric Cancer; Inflammatory Bowel Diseases; Gastric Ulcer; Hemorrhoids; Hernia

Outcome Measures

Primary Outcomes (1)

• Confirmation of diagnosis by pathologist

  Once tissue is collected, those samples that have a confirmed diagnosis of disease by the pathologist will be used.

  Up to 3 years

Study Arms (2)

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.

Non-malignant disease patient

Patients suffering from non-malignant disease scheduled to have surgery.

Other: No intervention will be given to patients.

Interventions

No intervention will be given to patients. OTHER

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.

Colorectal cancer or gastric cancer patient; Non-malignant disease patient

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who are planning to undergo surgery.

You may qualify if:

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

You may not qualify if:

• Subjects whose comorbidities would preclude diagnostic or therapeutic intervention.

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead

Study Sites (1)

Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimens will be analyzed to study, but not limited to, genomics, epigenomics, and proteomics.

MeSH Terms

Conditions

Colorectal Neoplasms; Stomach Neoplasms; Inflammatory Bowel Diseases; Stomach Ulcer; Hemorrhoids; Hernia

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Tao Fu, MD

  Renmin Hospital of Wuhan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Fu, MD

CONTACT

+8613720120190; tfu001@whu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of GI Surgery II

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 4, 2019
• Study Start: December 23, 2020
• Primary Completion: December 23, 2023
• Study Completion (Estimated): December 23, 2026
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

CN (1)