Tumor Budding in Patients With Colorectal Cancer Under Different MMR Status
November 8, 2022 updated by: Yanhong Deng, Sun Yat-sen University
Prognostic Impact of Tumor Budding and Tumor-infiltrating Lymphocytes in Patients With Colorectal Cancer Under Different MMR Status: A Single-Center, Open-Label, Retrospective, Observational Cohort Study
This study investigates the ability of tumor budding to identify prognosis in different MMR states and different levels of tumor lymphocyte infiltration.
Tumor budding is usually defined as an isolated single cancer cell or a cluster of up to four cancer cells located at the front of an infiltrating tumor.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
As a component of the tumor microenvironment, tumor budding is associated with the epidermal mesenchymal transition of tumor cells and may predict disease progression and poor survival.
The current assessment of tumor budding levels is mainly based on the ITBCC grading system.
The dMMR phenotype of colorectal cancer is associated with the generation of non-self-recognizing neoantigens by the immune system, with tumor-associated extensive inflammatory cell infiltration, and often the dMMR phenotype of colorectal cancer has a lower level of outgrowth, possibly with the generation of local immune responses capable of eradicating tumor budding cells.
The prognostic value of the conventional tumor budding grading system has been validated mainly in stage I and II colorectal cancers and does not consider the effect of MMR status on tumor budding.
This retrospective study is designed to investigate whether the high grade of tumor budding under high immune response status implies immune escape of tumor cells and brings worse survival outcome, establish a more independent risk grading system to maximize the prognostic value of tumor budding in dMMR phenotype of colorectal cancer in combination with tumor-infiltrating lymphocytes.
Study Type
Observational
Enrollment (Actual)
480
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Department of Colorectal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 76 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Rectal cancer patients underwent curative surgery
Description
Inclusion Criteria:
- Confirmed colorectal adenocarcinoma cancer pathologically
- Underwent primary surgery
- With records for tumor budding staining
- Willing and able to provide written informed consent for participation in this study
- Non-complicated primary tumor (complete obstruction, perforation, bleeding)
Exclusion Criteria:
- With distant metastases at the time of initial diagnosis
- Without a complete pathological date
- Hereditary colorectal cancer
- Subjects with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Rectal cancer
patients underwent curative surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
5-year event-free survival rate
Time Frame: 5 years after the surgery
|
5 years after the surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
5-year overall survival rate
Time Frame: 5 years after the surgery
|
5 years after the surgery
|
|
|
Local recurrence
Time Frame: 5 years after the surgery
|
Defined as an intrapelvic recurrence following a primary rectal cancer resection, with or without distal metastasis
|
5 years after the surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2009
Primary Completion (Actual)
November 1, 2022
Study Completion (Actual)
November 1, 2022
Study Registration Dates
First Submitted
November 4, 2022
First Submitted That Met QC Criteria
November 8, 2022
First Posted (Actual)
November 9, 2022
Study Record Updates
Last Update Posted (Actual)
November 9, 2022
Last Update Submitted That Met QC Criteria
November 8, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIHSYSU-31
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
Anonymous information may be provided upon reasonable request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.