Multidisciplinary CommunicationNCT05076305
PelvEx 4: Advanced Pelvic Malignancy and the Role of the Multi-disciplinary Team Meeting
An observational study of Multidisciplinary Communication and Locally Advanced Rectal Cancer, run by St Vincent's University Hospital, Ireland at 1 site in Ireland.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multidisciplinary Communication, Locally Advanced Rectal Cancer, Recurrent Rectal Cancer
- What is being tested?
- No specific intervention; cases are retrospective and patients have already been treated.
- How many people
- 12 participants
- Where
- 1 siteIreland
- Study dates
- 15 Oct 2021to 1 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with locally advanced or recurrent pelvic maligancy who have been treated at a participating PelvEx centre.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PelvEx 4: Advanced Pelvic Malignancy and the Role of the Multi-disciplinary Team Meeting - An International Assessment of MDT Decisions
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.
- Conditions
- Multidisciplinary Communication, Locally Advanced Rectal Cancer, Recurrent Rectal Cancer, Multidisciplinary Team Meeting (MDT), Treatment Decisions
- Being tested
- No specific intervention; cases are retrospective and patients have already been treated.
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No specific intervention; cases are retrospective and patients have already been treated.Other
To assess the geographic variation that exists in the management of locally advanced and recurrent rectal cancers.
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional/geographic variation in MDT treatment allocations
Treatment consensus reached for each individual case
Measured: Through study completion, an average of three months
Assessment of resectability
Was the malignancy felt to be resectable by MDT consensus at that institution
Measured: Through study completion, an average of three months
Secondary outcomes (1)
Assessment of staging
Concordance between centres on the TNM staging of disease
Measured: Through study completion, an average of three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start15 Oct 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multidisciplinary CommunicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Vincent's University Hospital, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- PelvEx collaborative
- Responsible party
- Principal investigator, Professor Des Winter, St Vincent's University Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076305
- Sponsor's protocol ID
- STVINCENTS
- Status last verified
- Oct 2021
- First submitted
- 19 Apr 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PelvEx 4: Advanced Pelvic Malignancy and the Role of the Multi-disciplinary Team Meeting - An International Assessment of MDT Decisions
- ClinicalTrials.gov ID
- NCT05076305
- Acronym / sponsor ID
- STVINCENTS
- Conditions
- Multidisciplinary Communication, Locally Advanced Rectal Cancer, Recurrent Rectal Cancer, Multidisciplinary Team Meeting (MDT), Treatment Decisions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- St Vincent's University Hospital, IrelandUniversity, hospital or other
- Collaborators
- PelvEx collaborative
- Study start
- 15 Oct 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced or recurrent pelvic maligancy who have been treated at a participating PelvEx centre.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No 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. | Other | – |
Primary outcome
Regional/geographic variation in MDT treatment allocations
Time frame: Through study completion, an average of three months
Treatment consensus reached for each individual case
Assessment of resectability
Time frame: Through study completion, an average of three months
Was the malignancy felt to be resectable by MDT consensus at that institution
1 secondary outcome
Assessment of staging
Time frame: Through study completion, an average of three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multidisciplinary Communication and Locally Advanced Rectal Cancer, run by St Vincent's University Hospital, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew Fahy (0874510237, mfahy94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional/geographic variation in MDT treatment allocations (time frame: Through study completion, an average of three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.