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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05513716
Other study ID # CFTSp216
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 4, 2024
Est. completion date July 3, 2025

Study information

Verified date September 2023
Source The Christie NHS Foundation Trust
Contact Ashley Osborne, Mr
Phone 0161 446 3000
Email ashley.osborne2@nhs.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date July 3, 2025
Est. primary completion date July 3, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
The Christie NHS Foundation Trust University of Manchester

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of genetic mutations Descriptive analysis of the proportion of genetic mutations identified in colorectal cancer and their matched peritoneal metastases: concordance and discordance rates. 24 months
Secondary Proportion differences of genetic mutations 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
Secondary Correlations of results Correlation of results from genetic tests with clinical patient data. Identification of genetic mutations which are associated with differences in survival. 24 months
Secondary Association with molecular subtypes and categorical variables 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
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