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NCT04130971 Clinical Trial

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

Colorectal Neoplasms Clinical Trial

— Predict  

Official title:
Predict - a Translational Study to Predict Tumour Response to Neoadjuvant Treatment

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04130971
Other study ID # Predict
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2019
Est. completion date December 31, 2027

Study information
Verified date November 2023
Source Sahlgrenska University Hospital, Sweden
Contact Eva Angenete
Phone 0760514441
Email eva.angenete@vgregion.se
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 800
Est. completion date December 31, 2027
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Colorectal cancer Exclusion Criteria: - Not colorectal cancer

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention, just observation
No intervention, just observation of the differences between groups and within patients.

Locations
Country Name City State
Sweden Dept. of Surgery, Sahlgrenska University Hospital/Ostra Gothenburg

Sponsors (2)
Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tumour response to treatment Tumour microenviroment changes 1-2 months after initiated treatment
Secondary Normal tissue response to treatment Extra cellular matrix changes 1month -3 years after treatment
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