Molecular Characterisation of Colorectal Cancer Peritoneal Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Retrospective tissue sample analysis.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer Metastatic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Molecular Characterisation of Colorectal Cancer Peritoneal Metastases: Genomic and Transcriptomic Analysis With Correlation of Clinical Outcomes
Overview
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.
Interventions
- 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
Primary outcome measures
- Proportion of genetic mutations [Time frame: 24 months]
Secondary outcome measures (3)
- Proportion differences of genetic mutations [Time frame: 24 months]
- Correlations of results [Time frame: 24 months]
- Association with molecular subtypes and categorical variables [Time frame: 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
United Kingdom · 1 center
- Christie Hospital NHS Foundation Trust — Manchester
Identifiers
NCT: NCT05513716 · CFTSp216