Tumor Budding in Patients With Colorectal Cancer Under Different MMR Status

Sponsor
Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT05610592
Collaborator
(none)
480
1
166
2.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: total mesorectal exicision

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 Design

Study Type:
Observational
Actual Enrollment :
480 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
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
Actual Study Start Date :
Jan 1, 2009
Actual Primary Completion Date :
Nov 1, 2022
Actual Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Rectal cancer

patients underwent curative surgery

Procedure: total mesorectal exicision

Outcome Measures

Primary Outcome Measures

  1. 5-year event-free survival rate [5 years after the surgery]

Secondary Outcome Measures

  1. 5-year overall survival rate [5 years after the surgery]

  2. Local recurrence [5 years after the surgery]

    Defined as an intrapelvic recurrence following a primary rectal cancer resection, with or without distal metastasis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  1. Confirmed colorectal adenocarcinoma cancer pathologically

  2. Underwent primary surgery

  3. With records for tumor budding staining

  4. Willing and able to provide written informed consent for participation in this study

  5. Non-complicated primary tumor (complete obstruction, perforation, bleeding)

Exclusion Criteria:
  1. With distant metastases at the time of initial diagnosis

  2. Without a complete pathological date

  3. Hereditary colorectal cancer

  4. Subjects with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University Guangzhou Guangdong China 510000

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yanhong Deng, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT05610592
Other Study ID Numbers:
  • GIHSYSU-31
First Posted:
Nov 9, 2022
Last Update Posted:
Nov 9, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yanhong Deng, Professor, Sun Yat-sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 9, 2022