NCT05696002

Brief Summary

Retrospective and prospective observational study of patients undergoing advanced pelvic oncological resection for maligancy including multi visceral resection, beyond TME resection and sacrectomy/flap reconstruction/urinary reconstruction at Glasgow Royal Infirmary. Goal is to study and report outcomes for patients to characterise and understand major complications, natural history of resectional patients and identify areas for future interventional study.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Jan 2023

Longer than P75 for all trials

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

Study Progress48%
Jan 2023Jan 2030

First Submitted

Initial submission to the registry

January 10, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

January 14, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

5 years

First QC Date

January 10, 2023

Last Update Submit

January 13, 2023

Conditions

Rectal CancerPelvic CancerGynecologic CancerColon Cancer

Keywords

Pelvic exenterationAbdominoperineal resectionReconstructive flapRectal cancer

Outcome Measures

Primary Outcomes (4)

  • Cancer-specific survival

    Months

    10 years

  • Overall survival

    Months

    10 years

  • Post-operative complications

    Frequency

    10 years

  • Quality of life (survey)

    Score

    10 years

Study Arms (1)

Advanced pelvic oncological resection

Complex resection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Tertiary referral centre

You may qualify if:

  • Advanced pelvic oncological resection defined as more than 1 pelvic organ resected

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Department of Surgery, Glasgow Royal Infirmary

Glasgow, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Not currently, but in the future, plans to study circulating immune cell/cytokine measurements, ctDNA, peritoneal macrophage/neutrophils, and existing protocols for biobanking of tumour samples/organoids

MeSH Terms

Conditions

Rectal NeoplasmsPelvic NeoplasmsColonic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Colin Steele, PhD FRCS

    Glasgow Royal Infirmary

    STUDY DIRECTOR

Central Study Contacts

Norman Galbraith, PhD MRCS

CONTACT

07449784948norman.galbraith@glasgow.ac.uk

Colin Steele, PhD FRCS

CONTACT

07449784948colin.steele@glasgow.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
NES/CSO Clinical Lecturer in Surgery

Study Record Dates

First Submitted

January 10, 2023

First Posted

January 25, 2023

Study Start

January 14, 2023

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2030

Last Updated

January 25, 2023

Record last verified: 2023-01

Locations

GB(1)