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Clinical Trials/NCT05513716
NCT05513716
Recruiting
N/A

Molecular Characterisation of Colorectal Cancer Peritoneal Metastases: Genomic and Transcriptomic Analysis With Correlation of Clinical Outcomes

The Christie NHS Foundation Trust1 site in 1 country200 target enrollmentFebruary 4, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Colorectal Cancer Metastatic
Sponsor
The Christie NHS Foundation Trust
Enrollment
200
Locations
1
Primary Endpoint
Proportion of genetic mutations
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

This project aims to characterise the tumour cell and tumour microenvironment of colorectal cancer peritoneal metastases, understand molecular changes leading to colorectal peritoneal metastasis, identify potential biomarkers and novel treatment strategies.

Detailed Description

The peritoneum is the second most common site for recurrence in colorectal cancer (CRC). Cancer spread to the peritoneum (colorectal cancer peritoneal metastases, CRPM) cause severe symptoms in patients and lead to shortened survival. The only definitive treatment available is a complex and aggressive surgical procedure involving radical removal of organs and the internal lining of the abdomen. The biology of CRPM and correlations with clinical outcomes has been reported in small numbers of patients. There has been limited research on how extended cancer mutations lead to metastases and how this can affect treatment or survival. Understanding how genetic mutations evolve in CRPM and the role of the tumour microenvironment are important for optimising treatment and prevent the spread of cancer. This study proposes completing cancer genetic profiling on archived tissue removed routinely from patients who previously have had surgery for CRPM. High through-put laboratory techniques for analysing the genetic profile of CRC and CRPM has the power to identify mutation patterns than might predict for treatments and survival outcomes. The results of genetic tests can then be compared to clinical characteristics, such as survival and treatments received. Genes in primary colorectal cancer can be compared to those in CRPM to describe what changes during the metastatic process. This study will help make progress towards better and personalised treatment options, identifying predictors of treatment success and long-term survival. Improved treatments and better selection of patients may ultimately improve quality of life and help patients live longer.

Registry
clinicaltrials.gov
Start Date
February 4, 2024
End Date
July 3, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Proportion of genetic mutations

Time Frame: 24 months

Descriptive analysis of the proportion of genetic mutations identified in colorectal cancer and their matched peritoneal metastases: concordance and discordance rates.

Secondary Outcomes

  • Association with molecular subtypes and categorical variables(24 months)
  • Proportion differences of genetic mutations(24 months)
  • Correlations of results(24 months)

Study Sites (1)

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