NCT05513716

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
1.4 years until next milestone

Study Start

First participant enrolled

February 4, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2025

Completed
Last Updated

January 1, 2025

Status Verified

December 1, 2024

Enrollment Period

1.4 years

First QC Date

August 22, 2022

Last Update Submit

December 31, 2024

Conditions

Colorectal Cancer Metastatic

Keywords

Colorectal Cancer Peritoneal Metastatic

Outcome Measures

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.

    24 months

Secondary Outcomes (3)

  • Proportion differences of genetic mutations

    24 months

  • Correlations of results

    24 months

  • Association with molecular subtypes and categorical variables

    24 months

Study Arms (1)

All patients

Colorectal cancer patients

Other: Retrospective tissue sample analysis

Interventions

Retrospective tissue sample analysisOTHER

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

All patients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Colorectal cancer peritoneal metastases

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christie Hospital NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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

Central Study Contacts

Richa Garvia, Ms

CONTACT

0161 446 3000removed_due_to_spam@email.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2022

First Posted

August 24, 2022

Study Start

February 4, 2024

Primary Completion

July 3, 2025

Study Completion

July 3, 2025

Last Updated

January 1, 2025

Record last verified: 2024-12

Locations

GB(1)