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Status unknownNCT05076305Updated Oct 13, 2021

PelvEx 4: Advanced Pelvic Malignancy and the Role of the Multi-disciplinary Team Meeting

An observational study in Multidisciplinary Communication, Locally Advanced Rectal Cancer and Recurrent Rectal Cancer, sponsored by St Vincent's University Hospital, Ireland. Status unknown at 1 site in Ireland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-10-13.

Sponsored by St Vincent's University Hospital, Ireland · Observational

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the detailed description

The PelvEx collaborative is an international research collaborative that was designed with the aim of collating data on patients undergoing pelvic exenteration from all corners of the globe. These extensive procedures, despite their associated morbidity, have revolutionised the approach to advanced pelvic malignancy and provide hope to patients whose cancers would have once been deemed inoperable. Despite the increasing frequency with which surgeons are performing these more radical resections (1), relatively few of these procedures are carried out when compared with more traditional surgical operations. Furthermore, this cohort of patients and the wide-ranging procedures which they undergo represent a heterogenous group. These factors combine to make it more difficult for academic surgeons to draw meaningful conclusions from their study, and further illustrate the need for prospective international collaboration in order to inform appropriate treatment strategies.

However, despite the great demand for international collaboration, it is vital that there is an appreciation of the variation in the approach to managing these complex cases between hospitals, countries and continents. While surgeons would like to believe that in any case where their local multi-disciplinary team meeting has made an informed treatment decision that it is the single most appropriate option, geographic variation in beliefs, attitudes, terminology and patient preferences may influence those decisions at an individual level. Nowhere is this more relevant than in the approach to advanced pelvic malignancy. One study analysing regional variation in the management of locally advanced and recurrent rectal cancer noted a significantly lower rate of pelvic exenteration in France when compared with Australia, despite intercountry blinding of radiological findings (2). These differences are influenced by a host of psychosocial factors that are as yet to be fully elucidated.

The goal of the present analysis is to provide further insight in to the geographical variation that exists in the assessment of the patients who are potential candidates for a pelvic exenteration in the hope that it will improve our understanding of these differences and increase the validity of the conclusions that can be drawn from our research on a prospective collaborative basis.

This will be performed by having "real-world" cases selected by our participating centres, anonymising the case and radiological information necessary and by presenting these cases over a series of weeks at MDT meetings all over the world. The data will then be analysed to assess the differences in the ways that certain groups/countries approach the management of these complex and highly varied cases.

02

Conditions studied

  • Multidisciplinary Communication
  • Locally Advanced Rectal Cancer
  • Recurrent Rectal Cancer
  • Multidisciplinary Team Meeting (MDT)
  • Treatment Decisions

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03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's planned enrollment of 12 is below the median of 160 across 413 observational studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

St Vincent's University Hospital, Ireland is the lead sponsor of 20 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Eligibility criteria

Inclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12 participants (estimated)
Patient registry
No

Interventions

  • OtherNo specific intervention; cases are retrospective and patients have already been treated.

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

06

What researchers measure

Primary outcomes

  1. Regional/geographic variation in MDT treatment allocations

    Treatment consensus reached for each individual case

    Time frame: Through study completion, an average of three months

  2. Assessment of resectability

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

    Time frame: Through study completion, an average of three months

Secondary outcomes

  1. Assessment of staging

    Concordance between centres on the TNM staging of disease

    Time frame: Through study completion, an average of three months

07

Study locations

1 site
  • St. Vincent's Hospital
    Dublin, D4, Ireland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05076305
Lead sponsor
St Vincent's University Hospital, Ireland
Collaborators
PelvEx collaborative
Responsible party
Professor Des Winter (Consultant Gastrointestinal Surgeon, St Vincent's University Hospital, Ireland) — Principal investigator
First posted
Oct 13, 2021
Start date
Oct 15, 2021 (estimated)
Primary completion
Dec 1, 2021 (estimated)
Completion
Feb 1, 2022 (estimated)
Last update
Oct 13, 2021

Study contacts

Matthew Fahy
Contact
mfahy94@gmail.com
0874510237

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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