Colorectal CancerNCT06115837
Prognosis Stratification for pT4bN0M0 Colorectal Cancer Following Multivisceral Resection
An observational study of Colorectal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study was to identify the prognostic factors of affecting pT4bN0M0 colorectal cancer patients, so as to better stratify the prognostic differences among patients with the same stage. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- multivisceral resection
- Type of treatment
- Surgery or procedure
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 26 Sep 2023
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient experienced multivisceral resection for pT4bN0M0 colorectal cancer from January 2010 to December 2021.
Who may be able to join
- The patient was pathologically diagnosed as colorectal adenocarcinoma.
- Patients with pT4bN0M0 colorectal cancer.
- Patients with R0 resection.
Who cannot join
- Patients with distant metastasis.
- Patients with R1 or R2 resection.
- Patients with lymph node metastasis
- Recurrent colorectal cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognosis Stratification for pT4bN0M0 Colorectal Cancer Following Multivisceral Resection: A Multi-institutional Retrospective Analysis
The purpose of this study was to identify the prognostic factors of affecting pT4bN0M0 colorectal cancer patients, so as to better stratify the prognostic differences among patients with the same stage.
Read the detailed description
Patients with pT4b stage colorectal cancer (CRC) are a complex and special group due to the diversity of infiltrated organs, patients with the same stage often have different prognosis after multivisceral resection (MVR), some important prognostic factors have not been deeply explored, and additional prognostic factors are needed to improve the survival assessment of these patients. In this study, investigators attempted to evaluate the prognostic factors of pT4bN0M0 colorectal cancer, and then stratify the prognosis of such patients to distinguish the survival differences among different patients.
This study was a multicenter retrospective cohort study based on a multicenter database which contained hospitalization.The prognostic factors of pT4bN0M0 colorectal cancer patients were analyzed, and the prognostic grading system was constructed to accurately stratify the survival of pT4bN0M0 patients.
- Conditions
- Colorectal Cancer
- Being tested
- multivisceral resection
- Keywords
- Colorectal Cancer, Multivisceral resection, Prognosis
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multivisceral resectionProcedure or surgery
The prognostic factors were analyzed for pT4bN0M0 colorectal cancer after multivisceral resection
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival is defined as the time from the surgery to death or last follow-up, regardless of disease recurrence, which was measured in months.
Measured: The endpoint of the overall survival assessment is the last follow-up or patient death. Follow-up time is up to 72 months.
Cancer specific survival
Cancer specific survival is defined as the time from the diagnosis to death due to cancer progression, which was measured in months.
Measured: The endpoint of the cancer specific survival assessment is the patient death due to cancer. Follow-up time is up to 72 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Sep 2023
- Primary completion16 Sep 2023
- Study completion26 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianqiang Tang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115837
- Sponsor's protocol ID
- NCC2330
- Status last verified
- Oct 2023
- First submitted
- 30 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Quan J, Zuo K, Li G, Liu J, Mei S, Hu G, Qiu W, Zhuang M, Meng L, Wang X, Chang H, Tang J. Prognostic stratification of patients with pT4bN0M0 colorectal cancer following multivisceral resection: a multi-institutional case series analysis. Int J Surg. 2024 Sep 1;110(9):5323-5333. doi: 10.1097/JS9.0000000000001646.
PubMed 38768462
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis Stratification for pT4bN0M0 Colorectal Cancer Following Multivisceral Resection: A Multi-institutional Retrospective Analysis
- ClinicalTrials.gov ID
- NCT06115837
- Acronym / sponsor ID
- NCC2330
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Multivisceral resection, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 16 Sep 2023 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 3 Nov 2023 (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 purpose of this study was to identify the prognostic factors of affecting pT4bN0M0 colorectal cancer patients, so as to better stratify the prognostic differences among patients with the same stage.
Detailed description
Patients with pT4b stage colorectal cancer (CRC) are a complex and special group due to the diversity of infiltrated organs, patients with the same stage often have different prognosis after multivisceral resection (MVR), some important prognostic factors have not been deeply explored, and additional prognostic factors are needed to improve the survival assessment of these patients. In this study, investigators attempted to evaluate the prognostic factors of pT4bN0M0 colorectal cancer, and then stratify the prognosis of such patients to distinguish the survival differences among different patients.
This study was a multicenter retrospective cohort study based on a multicenter database which contained hospitalization.The prognostic factors of pT4bN0M0 colorectal cancer patients were analyzed, and the prognostic grading system was constructed to accurately stratify the survival of pT4bN0M0 patients.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient experienced multivisceral resection for pT4bN0M0 colorectal cancer from January 2010 to December 2021.
Key inclusion criteria (3 listed)
- The patient was pathologically diagnosed as colorectal adenocarcinoma.
- Patients with pT4bN0M0 colorectal cancer.
- Patients with R0 resection.
Key exclusion criteria (4 listed)
- Patients with distant metastasis.
- Patients with R1 or R2 resection.
- Patients with lymph node metastasis
- Recurrent colorectal cancer.
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 |
|---|---|---|
| multivisceral resectionThe prognostic factors were analyzed for pT4bN0M0 colorectal cancer after multivisceral resection | Procedure or surgery | – |
Primary outcome
Overall survival
Time frame: The endpoint of the overall survival assessment is the last follow-up or patient death. Follow-up time is up to 72 months.
Overall survival is defined as the time from the surgery to death or last follow-up, regardless of disease recurrence, which was measured in months.
Cancer specific survival
Time frame: The endpoint of the cancer specific survival assessment is the patient death due to cancer. Follow-up time is up to 72 months.
Cancer specific survival is defined as the time from the diagnosis to death due to cancer progression, which was measured in months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Derived from this study: PubMed 38768462Quan J, Zuo K, Li G, Liu J, Mei S, Hu G, Qiu W, Zhuang M, Meng L, Wang X, Chang H, Tang J. Prognostic stratification of patients with pT4bN0M0 colorectal cancer following multivisceral resection: a multi-institutional case series analysis. Int J Surg. 2024 Sep 1;110(9):5323-5333. doi: 10.1097/JS9.0000000000001646.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 3 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: The endpoint of the overall survival assessment is the last follow-up or patient death. Follow-up time is up to 72 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06115837, which also lists 1 linked publication.
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 3 Nov 2023.