NCT05076305

Brief Summary

The treatment of locally advanced and recurrent rectal cancers is highly individualized to each patient and their pattern of disease, and this decision is often made at the Multidisciplinary Team (MDT) meeting . The PelvEx collaborative was designed with the intent to provide greater international consensus on appropriate treatment decisions for this cohort. However, we propose that international variation exists in how certain patients will be evaluated, assessed and ultimately treated despite having the same disease. We plan to measure this variation in order to provide a greater understanding of the differences that exist.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 19, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 13, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

October 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

October 13, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

April 19, 2021

Last Update Submit

October 12, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Regional/geographic variation in MDT treatment allocations

    Treatment consensus reached for each individual case

    Through study completion, an average of three months

  • Assessment of resectability

    Was the malignancy felt to be resectable by MDT consensus at that institution

    Through study completion, an average of three months

Secondary Outcomes (1)

  • Assessment of staging

    Through study completion, an average of three months

Interventions

To assess the geographic variation that exists in the management of locally advanced and recurrent rectal cancers.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with locally advanced or recurrent pelvic maligancy who have been treated at a participating PelvEx centre.

You may qualify if:

  • Complex case from participating PelvEx centre
  • Complete clinical information available to allow for informed MDT assessment
  • DICOM files for sharing of imaging related to treatment decisions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Vincent's Hospital

Dublin, D4, Ireland

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Matthew Fahy

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Gastrointestinal Surgeon

Study Record Dates

First Submitted

April 19, 2021

First Posted

October 13, 2021

Study Start

October 15, 2021

Primary Completion

December 1, 2021

Study Completion

February 1, 2022

Last Updated

October 13, 2021

Record last verified: 2021-10

Locations