Tumor Budding in Patients With Colorectal Cancer Under Different MMR Status

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: Rectal Cancer; Tumor Budding
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 480

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Department of Colorectal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University

Participation Criteria

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:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rectal cancer; patients underwent curative surgery	Procedure: total mesorectal exicision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
5-year event-free survival rate	5 years after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-year overall survival rate		5 years after the surgery
Local recurrence	Defined as an intrapelvic recurrence following a primary rectal cancer resection, with or without distal metastasis	5 years after the surgery

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

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: Rectal cancer; Tumor budding
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• 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