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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03972956
Recruitment Status : Not yet recruiting
First Posted : June 4, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Tao Fu, Renmin Hospital of Wuhan University

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.

Condition or disease Intervention/treatment
Colorectal Cancer Gastric Cancer Inflammatory Bowel Diseases Gastric Ulcer Hemorrhoids Hernia Other: No intervention will be given to patients.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Samples Procurement for Patients With Colorectal Cancer, Gastric Cancer, and Non-malignant Disease Undergoing Surgery
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : November 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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.




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Biospecimens will be analyzed to study, but not limited to, genomics, epigenomics, and proteomics.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Participants who are planning to undergo surgery.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03972956


Contacts
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Contact: Tao Fu, MD +8613720120190 tfu001@whu.edu.cn

Locations
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China, Hubei
Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430060
Sponsors and Collaborators
Renmin Hospital of Wuhan University
Investigators
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Principal Investigator: Tao Fu, MD Renmin Hospital of Wuhan University

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Responsible Party: Tao Fu, Director of Department of GI Surgery II, Renmin Hospital of Wuhan University
ClinicalTrials.gov Identifier: NCT03972956    
Other Study ID Numbers: SAMPGICUS
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Stomach Neoplasms
Inflammatory Bowel Diseases
Hemorrhoids
Stomach Ulcer
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
Vascular Diseases
Cardiovascular Diseases
Peptic Ulcer
Duodenal Diseases