Clinical trial NCT05513716: Molecular Characterisation of Colorectal Cancer Peritoneal Metastases
Official title: Molecular Characterisation of Colorectal Cancer Peritoneal Metastases: Genomic and Transcriptomic Analysis With Correlation of Clinical Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer Metastatic
Keywords: Colorectal Cancer Peritoneal Metastatic
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Manchester
First posted: 2022-08-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Colorectal cancer peritoneal metastases

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of genetic mutations
timeFrame: 24 months
Secondary outcomes:
measure: Proportion differences of genetic mutations
timeFrame: 24 months
measure: Correlations of results
timeFrame: 24 months
measure: Association with molecular subtypes and categorical variables
timeFrame: 24 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Foundation Trust
Study officials:
References: