- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04130971
Predicting Colorectal Cancer - Tissue Samples to Evaluate Tumour Characteristics and Treatment Response (Predict)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Eva Angenete
- Phone Number: 0760514441
- Email: eva.angenete@vgregion.se
Study Locations
-
-
-
Gothenburg, Sweden, SE 416 85
- Recruiting
- Dept. of Surgery, Sahlgrenska University Hospital/Ostra
-
Contact:
- Eva Angenete, MD,PhD
- Phone Number: +46313438410
- Email: eva.angenete@vgregion.se
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Colorectal cancer
Exclusion Criteria:
- Not colorectal cancer
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients without neoadjuvant treatment
|
No intervention, just observation of the differences between groups and within patients.
|
Patients with short course radiotherapy
|
No intervention, just observation of the differences between groups and within patients.
|
Patients with long course chemoradiotherapy
|
No intervention, just observation of the differences between groups and within patients.
|
Patients with short course radiotherapy and deferred surgery
|
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
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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