Clinical trial NCT05610592: Tumor Budding in Patients With Colorectal Cancer Under Different MMR Status
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tumor Budding
Rectal Cancer
Keywords: Tumor budding
Rectal cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-11-09
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rectal cancer patients underwent curative surgery

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 5-year event-free survival rate
timeFrame: 5 years after the surgery
Secondary outcomes:
measure: 5-year overall survival rate
timeFrame: 5 years after the surgery
measure: Local recurrence
timeFrame: 5 years after the surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
References: