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

Recruiting

• Conditions: Colorectal Neoplasms
• Interventions: Other: No intervention, just observation

• Registration Number: NCT04130971
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• Colorectal cancer

Exclusion Criteria

• Not colorectal cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with long course chemoradiotherapy	No intervention, just observation	-
Patients with short course radiotherapy and deferred surgery	No intervention, just observation	-
Patients without neoadjuvant treatment	No intervention, just observation	-
Patients with short course radiotherapy	No intervention, just observation	-

Primary Outcome Measures

Name	Time	Method
Tumour response to treatment	1-2 months after initiated treatment	Tumour microenviroment changes

Secondary Outcome Measures

Name	Time	Method
Normal tissue response to treatment	1month -3 years after treatment	Extra cellular matrix changes

Trial Locations

Locations (1)

Dept. of Surgery, Sahlgrenska University Hospital/Ostra; 🇸🇪 Gothenburg, Sweden