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NCT Number: NCT05513716

Molecular Characterisation of Colorectal Cancer Peritoneal Metastases

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.

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Key information

Conditions

Colorectal Cancer Metastatic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Christie Hospital NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location status: Recruiting

Location contact

Richa Garvia

CONTACT

[email protected]

01614463000

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

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

Exclusion criteria

  • None

Treatment and study plan

Retrospective tissue sample analysis

Other

Archival formalin-fixed, paraffin-embedded (FFPE) tumour tissue from colorectal cancer peritoneal metastasis and paired primary tumours, where available - taken as standard care

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Richa Garvia, Ms

CONTACT

[email protected]

0161 446 3000

Sponsors and collaborators

Lead sponsor

The Christie NHS Foundation Trust

Other

Collaborators

  • University of Manchester

Registry information

Official study title

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

Acronym: COLOMET II

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2022
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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