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出境医 / 临床实验 / Samples Procurement for Colorectal Cancer, Gastric Cancer, and Non-malignant Disease
Samples Procurement for Colorectal Cancer, Gastric Cancer, and Non-malignant Disease
Study Description
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. |
Study Design
| 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 |
| Actual Study Start Date : | December 23, 2020 |
| Estimated Primary Completion Date : | December 23, 2023 |
| Estimated Study Completion Date : | December 23, 2026 |
Arms 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.
|
Outcome Measures
Primary Outcome Measures :
- 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.
Eligibility Criteria
| 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.
Contacts and Locations
Contacts
| Contact: Tao Fu, MD | +8613720120190 | tfu001@whu.edu.cn |
Locations
| China, Hubei | |
| Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University | Recruiting |
| Wuhan, Hubei, China, 430060 | |
| Contact: Tao Fu, MD 86-13720120190 futao1975@tom.com | |
Sponsors and Collaborators
Renmin Hospital of Wuhan University
Investigators
| Principal Investigator: | Tao Fu, MD | Renmin Hospital of Wuhan University |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 30, 2019 | ||||
| First Posted Date | June 4, 2019 | ||||
| Last Update Posted Date | March 23, 2021 | ||||
| Actual Study Start Date | December 23, 2020 | ||||
| Estimated Primary Completion Date | December 23, 2023 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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.
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Samples Procurement for Colorectal Cancer, Gastric Cancer, and Non-malignant Disease | ||||
| Official Title | Samples Procurement for Patients With Colorectal Cancer, Gastric Cancer, and Non-malignant Disease Undergoing Surgery | ||||
| 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description:
Biospecimens will be analyzed to study, but not limited to, genomics, epigenomics, and proteomics.
|
||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Participants who are planning to undergo surgery. | ||||
| Condition |
|
||||
| Intervention | 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.
|
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| Study Groups/Cohorts |
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
1000 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 23, 2026 | ||||
| Estimated Primary Completion Date | December 23, 2023 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years to 80 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts |
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| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03972956 | ||||
| Other Study ID Numbers | SAMPGICUS | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Tao Fu, Renmin Hospital of Wuhan University | ||||
| Study Sponsor | Renmin Hospital of Wuhan University | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Renmin Hospital of Wuhan University | ||||
| Verification Date | March 2021 | ||||
