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Trial Title:
Molecular Characterisation of Colorectal Cancer Peritoneal Metastases
NCT ID:
NCT05513716
Condition:
Colorectal Cancer Metastatic
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Colorectal Cancer Peritoneal Metastatic
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
Retrospective tissue sample analysis
Description:
Archival formalin-fixed, paraffin-embedded (FFPE) tumour tissue from colorectal cancer
peritoneal metastasis and paired primary tumours, where available - taken as standard
care
Arm group label:
All patients
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.
Criteria for eligibility:
Study pop:
Colorectal cancer peritoneal metastases
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Start date:
February 4, 2024
Completion date:
July 3, 2025
Lead sponsor:
Agency:
The Christie NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
University of Manchester
Agency class:
Other
Source:
The Christie NHS Foundation Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05513716
