Actively Recruiting
Investigating the Origins of Pelvic Recurrence in Colorectal Cancer Using a New Radiological Staging Classification System
Led by Imperial College London · Updated on 2024-10-17
383
Participants Needed
4
Research Sites
260 weeks
Total Duration
On this page
Sponsors
I
Imperial College London
Lead Sponsor
P
Pelican Cancer Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with recurrent colorectal cancer in the pelvis to improve surgical and treatment planning. The study focuses on evaluating a new imaging assessment proforma that details anatomic pelvic compartments and causes of disease recurrence. This research aims to better understand risk factors for recurrence by reviewing original tumor staging scans and surgical specimens. The study is prospective and retrospective, led by Imperial College London, and involves advanced colorectal cancers undergoing pelvic exenterative surgery. Participants will undergo a new radiological staging classification system using high-resolution MRI to assess tumor distribution in the pelvis. This new system is being evaluated to help surgeons decide which patients are suitable for radical surgery and to improve surgical planning. The imaging assessment proformas will be implemented to classify pelvic compartments and recurrence types, guiding treatment decisions. The study includes follow-up periods extending to three years to monitor outcomes. During the study, researchers will collect and analyze imaging scans, histopathology reports, and treatment data. Participants will be followed for up to three years to measure outcomes such as surgical success rates, recurrence types, quality of life after treatment, and healthcare costs. The study will compare MRI findings with clinical outcomes and histopathology to validate the staging system. Various assessments will be done at intervals from one to five years to evaluate prognosis, treatment effects, and inter-observer agreement on MRI classifications.
CONDITIONS
Brief Title
Beyond TME Origins
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Had a primary colorectal adenocarcinoma confirmed by biopsy
- Confirmed diagnosis of recurrent pelvic colorectal cancer
- Previously completed surgery for primary adenocarcinoma of colon, sigmoid colon, or rectum
- Able to undergo high-resolution MRI for staging before treatment decisions
- Provided written informed consent to participate
- Aged 16 years or older
You will not qualify if you...
- Have irresectable metastatic disease outside the pelvis
- Original baseline staging and preoperative restaging scans are unavailable
- Original preoperative, surgical, or adjuvant treatment details are undocumented or unavailable
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants undergo imaging assessment using a new radiological staging classification system to plan surgery for advanced and recurrent colorectal cancer.
Visits scheduled according to treatment planning and surgical care
Duration - Up to 5 years
Participants are monitored for clinical outcomes, quality of life, and radiology-pathology comparisons after treatment.
Periodic follow-up visits over several years
Trial Site Locations
Total: 4 locations
1
Oslo University Hospital
Oslo, Norway, N-0424
Actively Recruiting
2
St Mark's Hospital
Harrow, London, United Kingdom
Actively Recruiting
3
Churchill Hospital
Oxford, Oxfordshire, United Kingdom
Actively Recruiting
4
Royal Marsden Hospital NHS Foundation Trust
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
C
Caroline Martin
S
Syvella Ellis
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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