Colorectal CancerNCT03972956
Samples Procurement for Colorectal Cancer, Gastric Cancer, and Non-malignant Disease
An observational study of Colorectal Cancer and Gastric Cancer, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Gastric Cancer, Inflammatory Bowel Diseases
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2020to 23 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Participants who are planning to undergo surgery.
Who may be able to join
- Any patient diagnosed with colorectal cancer, gastric cancer, non-malignant disease that requires undergoing surgery.
- Must be willing and able to provide informed consent.
Who cannot join
- Subjects whose comorbidities would preclude diagnostic or therapeutic intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Tao Fu, MD, 86-13720120190, futao1975@tom.com
About this study
Official title: 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.
- Conditions
- Colorectal Cancer, Gastric Cancer, Inflammatory Bowel Diseases, Gastric Ulcer, Hemorrhoids, Hernia
- Being tested
- No intervention will be given to patients.
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms, Inflammatory Bowel Diseases, Stomach Ulcer, Hemorrhoids, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Colorectal cancer or gastric cancer patient | Patients suffering from CRC or gastric cancer scheduled to have surgical resection of colon/rectum or stomach. Receives: Other: No intervention will be given to patients. | |
| Non-malignant disease patient | Patients suffering from non-malignant disease scheduled to have surgery. Receives: Other: No intervention will be given to patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmation of diagnosis by pathologist
Once tissue is collected, those samples that have a confirmed diagnosis of disease by the pathologist will be used.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start23 Dec 2020
- Primary completion23 Dec 2023 (estimated)
- Study completion23 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Fu, Renmin Hospital of Wuhan University
- Investigators
- Tao Fu, MD, Principal investigator, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972956
- Sponsor's protocol ID
- SAMPGICUS
- Status last verified
- Apr 2022
- First submitted
- 30 May 2019
- Last updated
- 29 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Samples Procurement for Patients With Colorectal Cancer, Gastric Cancer, and Non-malignant Disease Undergoing Surgery
- ClinicalTrials.gov ID
- NCT03972956
- Acronym / sponsor ID
- SAMPGICUS
- Conditions
- Colorectal Cancer, Gastric Cancer, Inflammatory Bowel Diseases, Gastric Ulcer, Hemorrhoids, Hernia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 23 Dec 2023 (estimated)
- Study completion
- 23 Dec 2026 (estimated)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colorectal cancer or gastric cancer patient | – | Other: No intervention will be given to patients.Patients suffering from CRC or gastric cancer scheduled to have surgical resection of colon/rectum or stomach. |
| Non-malignant disease patient | – | Other: No intervention will be given to patients.Patients suffering from non-malignant disease scheduled to have surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants who are planning to undergo surgery.
Key inclusion criteria (2 listed)
- Any patient diagnosed with colorectal cancer, gastric cancer, non-malignant disease that requires undergoing surgery.
- Must be willing and able to provide informed consent.
Key exclusion criteria (1 listed)
- Subjects whose comorbidities would preclude diagnostic or therapeutic intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Colorectal cancer or gastric cancer patient, Non-malignant disease patient |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tao Fu, MD principal investigator
Renmin Hospital of Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Gastric Cancer, run by Renmin Hospital of Wuhan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Fu, MD (+8613720120190, tfu001@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmation of diagnosis by pathologist (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.