Molecular Characterisation of Colorectal Cancer Peritoneal Metastases (COLOMET II)

December 31, 2024 updated by: The Christie NHS Foundation Trust

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Colorectal cancer peritoneal metastases

Description

Participants are eligible to be included in the study only if all of the following criteria apply:

  1. Patients ≥ 18 years old who have been diagnosed with colorectal cancer and have colorectal peritoneal metastases,
  2. have had cytoreductive surgery at the Christie
  3. have availability of archival tumour tissue (paired CRC and CRPM)

Exclusion Criteria:

  • None

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All patients
Colorectal cancer patients
Other: Retrospective tissue sample analysis
Archival formalin-fixed, paraffin-embedded (FFPE) tumour tissue from colorectal cancer peritoneal metastasis and paired primary tumours, where available - taken as standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion differences of genetic mutations
Time Frame: 24 months
The descriptive difference in proportion of genetic mutations identified in primary colorectal tumours compared to mutations in colorectal cancer peritoneal metastases. Generate hypotheses about changes that occur during the metastatic process.
24 months
Correlations of results
Time Frame: 24 months
Correlation of results from genetic tests with clinical patient data. Identification of genetic mutations which are associated with differences in survival.
24 months
Association with molecular subtypes and categorical variables
Time Frame: 24 months
Association between molecular subtypes and categorical variables to be measured by Fisher's exact or X2 tests. Associations with continuous variables will be evaluated by Kruskal-Wallis tests or ANOVA. Kaplan-Meier methods will calculate survival outcomes. Univariate and multivariate cox proportional hazard regression models stratified by tumour subtype will identify predictive factors of clinical outcomes. Results with a p-value <0.05 will be considered statistically different.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Christie NHS Foundation Trust

Collaborators

University of Manchester

Investigators

  • Study Chair: Nadina Tinsley, Dr, University Of Manchester
  • Principal Investigator: Omer Aziz, Mr, The Christie NHS Foundation Trust

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)

February 4, 2024

Primary Completion (Estimated)

July 3, 2025

Study Completion (Estimated)

July 3, 2025

Study Registration Dates

First Submitted

August 22, 2022

First Submitted That Met QC Criteria

August 22, 2022

First Posted (Actual)

August 24, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 31, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFTSp216

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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