NCT05364788

Brief Summary

Patients ≥ 18 years old who have been diagnosed with appendiceal cancer with peritoneal metastases, have had cytoreductive surgery, have availability of archival tumour tissue and have consented to our institutional biobank program or have a waiver of consent for deceased patients who have not had the opportunity to provide biobank consent (requested at the time of ethics review). Descriptive analysis of the proportion of genetic mutations identified in appendiceal cancers. This is given by the percentage of pathogenic mutations in the peritoneal metastasis compared to the primary tumour.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-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

May 3, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2022

Completed
1.8 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

May 3, 2022

Last Update Submit

December 31, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Characterise the genes of appendiceal cancer.

    Descriptive analysis of the proportion of genetic mutations identified in appendiceal cancers. This is given by the percentage of pathogenic mutations in the peritoneal metastasis compared to the primary tumour.

    2 years

Secondary Outcomes (1)

  • Descriptive analysis in proportions

    2 years

Study Arms (1)

All participants

Appendiceal Cancer Patients

Other: Retrospective tissue sample analysis

Interventions

Acquisition of archival Formalin Fixed Paraffin Embedded (FFPE) human tissue from appendix cancer primary tumour and peritoneal metastases, which are stored in NHS pathology - taken from standard care biopsies.

All participants

Eligibility Criteria

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

Patients who have been diagnosed with appendiceal cancer with peritoneal metastases

You may qualify if:

  • 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 appendiceal cancer with peritoneal metastases,
  • have had cytoreductive surgery
  • have availability of archival tumour tissue

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Archival Formalin Fixed Paraffin Embedded (FFPE) human tissue from appendix cancer primary tumour and peritoneal metastases.

MeSH Terms

Conditions

Appendiceal Neoplasms

Condition Hierarchy (Ancestors)

Cecal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesCecal DiseasesIntestinal Diseases

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

May 3, 2022

First Posted

May 6, 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