Colorectal CancerNCT05086601
A Cohort of Molecular Characteristics and Prognosis of Colorectal Cancer
An observational study of Colorectal Cancer and Surgery, run by Fudan University at 1 site in China.
Trial summary
This study aims to establish a colorectal cancer cohort, collect clinicopathological information, collect biological samples for multi-omics testing, and perform relevant analysis, to predict the prognosis of colorectal cancer, guide the diagnosis and treatment of colorectal cancer and the formulation of health… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer, Surgery
- What is being tested?
- colorectal cancer surgery
- Type of treatment
- Surgery or procedure
- How many people
- 15,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 9 Sep 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients pathologically diagnosed as colorectal cancer, and receiving any surgery of primary tumor, including palliative resection, simple enterostomy and exploratory surgery
Who may be able to join
- Pathologically diagnosed as colorectal cancer
- Receiving any surgery of primary tumor, including palliative resection, simple enterostomy and exploratory surgery
Who cannot join
- The patient refused to join the study
- The patient refused to collect the biological sample
- The patient refused to follow up
Trial locations and contacts
1 site in 1 country.
Qingyang Feng, Dr. contact
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Qingyang Feng, Dr., +86-021-64041990, fqy198921@163.com
Jianmin Xu, Prof., xujmin@aliyun.com
About this study
This study aims to establish a colorectal cancer cohort, collect clinicopathological information, collect biological samples for multi-omics testing, and perform relevant analysis, to predict the prognosis of colorectal cancer, guide the diagnosis and treatment of colorectal cancer and the formulation of health policies.
Read the detailed description
In this study, the investigators will establish a database to collect clinical pathological information, based on the medical data system of participating medical centers. The investigators will also collect corresponding tumor specimens and perform multiple omics tests such as genome, transcriptome, and proteome. The investigators will aggregate these data into a special database, and use appropriate methods to conduct big data analysis, to predict prognosis, guide diagnosis and treatment, and assist in formulating health policies.
- Conditions
- Colorectal Cancer, Surgery
- Being tested
- colorectal cancer surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colorectal cancer surgeryProcedure or surgery
Any surgery for primary tumor of colorectal cancer, including palliative resection, simple bowel stoma and exploratory surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival time
For patients received radical resection of colorectal cancer, disease-free survival time is defined as time from the surgery to any recurrence of disease or death, recorded in months.
Measured: 2 yeas after surgery
Secondary outcomes (2)
Overall survival time
Overall survival time is defined as time from the surgery to death, recorded in months.
Measured: 2 yeas after surgery
Pathological TNM stage
The pathological TNM stage included the pathological T stage, pathological N stage and M stage. The pathological T and N stage is decided according to the removed specimen of the primary tumor by the pathologist after surgery. The M stage is decided according to the imaging tests as CT, MRI and PET-CT.
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 Dec 2020
- Primary completion9 Sep 2022 (estimated)
- Study completion9 Sep 2022 (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.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086601
- Sponsor's protocol ID
- CRCC2021
- Status last verified
- Mar 2021
- First submitted
- 23 Sep 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort of Molecular Characteristics and Prognosis of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05086601
- Acronym / sponsor ID
- CRCC2021
- Conditions
- Colorectal Cancer, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 9 Sep 2022 (estimated)
- Study completion
- 9 Sep 2022 (estimated)
- First posted
- 21 Oct 2021 (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.
This study aims to establish a colorectal cancer cohort, collect clinicopathological information, collect biological samples for multi-omics testing, and perform relevant analysis, to predict the prognosis of colorectal cancer, guide the diagnosis and treatment of colorectal cancer and the formulation of health policies.
Detailed description
In this study, the investigators will establish a database to collect clinical pathological information, based on the medical data system of participating medical centers. The investigators will also collect corresponding tumor specimens and perform multiple omics tests such as genome, transcriptome, and proteome. The investigators will aggregate these data into a special database, and use appropriate methods to conduct big data analysis, to predict prognosis, guide diagnosis and treatment, and assist in formulating health policies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients pathologically diagnosed as colorectal cancer, and receiving any surgery of primary tumor, including palliative resection, simple enterostomy and exploratory surgery
Key inclusion criteria (2 listed)
- Pathologically diagnosed as colorectal cancer
- Receiving any surgery of primary tumor, including palliative resection, simple enterostomy and exploratory surgery
Key exclusion criteria (3 listed)
- The patient refused to join the study
- The patient refused to collect the biological sample
- The patient refused to follow up
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 |
|---|---|---|
| colorectal cancer surgeryAny surgery for primary tumor of colorectal cancer, including palliative resection, simple bowel stoma and exploratory surgery. | Procedure or surgery | – |
Primary outcome
Disease-free survival time
Time frame: 2 yeas after surgery
For patients received radical resection of colorectal cancer, disease-free survival time is defined as time from the surgery to any recurrence of disease or death, recorded in months.
2 secondary outcomes
Overall survival time
Time frame: 2 yeas after surgery
Pathological TNM stage
Time frame: 1 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Qingyang Feng, Dr. contact
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 Surgery, run by Fudan 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 3 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: status not confirmed, as of the sponsor's last update on 21 Oct 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianmin Xu, Prof. (+86-021-64041990, xujmin@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival time (time frame: 2 yeas after surgery). 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 21 Oct 2021.