Actively Recruiting

Phase Not Applicable
Age: 16Years +
All Genders
ID02292641

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

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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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