Health TrialsbyHealthPanel

Molecular Characterisation of Colorectal Cancer Peritoneal Metastases

ConditionColorectal Cancer Metastatic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Christie NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

None

Trial population

Colorectal cancer peritoneal metastases

Trial design

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

  • Retrospective tissue sample analysis

    Other intervention

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: All patients1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
24 months

Secondary outcomes

1

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.

Time frame
24 months
2

Correlations of results

Correlation of results from genetic tests with clinical patient data. Identification of genetic mutations which are associated with differences in survival.

Time frame
24 months
3

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.

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Christie NHS Foundation Trust

Lead sponsor

University of Manchester

Collaborator

Source ClinicalTrials.gov
Apply now