Predicting Colorectal Cancer - Tissue Samples to Evaluate Tumour Characteristics and Treatment Response (Predict)

November 3, 2023 updated by: Eva Angenete, Sahlgrenska University Hospital, Sweden

Predict - a Translational Study to Predict Tumour Response to Neoadjuvant Treatment

All adult patients with colorectal cancer presenting within the Sahlgrenska University Hospital or treated at any time at Sahlgrenska University Hospital are eligible and will be asked to participate. We already have biopsies taken at surgery in patients that receive surgery, but this study will include all patients and the biopsies will be taken during endoscopy for diagnosis of the primary tumour. Biopsies will then be taken during follow-up exams prior surgery but after neoadjuvant treatment. Biopsies will also be taken during surgery and in cases where surgery is not necessary biopsies will be taken regularly during follow-up exams.

Blood samples and in relevant cases urinary samples and mouth swabs will be taken at all timepoints when biopsies are taken. If it is not possible to take biopsies prior treatment blood samples will still be drawn.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Gothenburg, Sweden, SE 416 85
        • Recruiting
        • Dept. of Surgery, Sahlgrenska University Hospital/Ostra
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients with a diagnosis of colorectal cancer are eligible.

Description

Inclusion Criteria:

  • Colorectal cancer

Exclusion Criteria:

  • Not colorectal cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients without neoadjuvant treatment
Other: No intervention, just observation
No intervention, just observation of the differences between groups and within patients.
Patients with short course radiotherapy
Other: No intervention, just observation
No intervention, just observation of the differences between groups and within patients.
Patients with long course chemoradiotherapy
Other: No intervention, just observation
No intervention, just observation of the differences between groups and within patients.
Patients with short course radiotherapy and deferred surgery
Other: No intervention, just observation
No intervention, just observation of the differences between groups and within patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumour response to treatment
Time Frame: 1-2 months after initiated treatment
Tumour microenviroment changes
1-2 months after initiated treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Normal tissue response to treatment
Time Frame: 1month -3 years after treatment
Extra cellular matrix changes
1month -3 years after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Collaborators

Göteborg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

October 16, 2019

First Submitted That Met QC Criteria

October 16, 2019

First Posted (Actual)

October 18, 2019

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREDICT (CardioDx)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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