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

NCT04130971 | Recruiting

• 1 other identifier: Predict
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Tumour response to treatment

  Tumour microenviroment changes

  1-2 months after initiated treatment

Secondary Outcomes (1)

• Normal tissue response to treatment

  1month -3 years after treatment

Study Arms (4)

Patients without neoadjuvant treatment

Other: No intervention, just observation

Patients with short course radiotherapy

Other: No intervention, just observation

Patients with long course chemoradiotherapy

Other: No intervention, just observation

Patients with short course radiotherapy and deferred surgery

Other: No intervention, just observation

Interventions

No intervention, just observation OTHER

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

Patients with long course chemoradiotherapy; Patients with short course radiotherapy; Patients with short course radiotherapy and deferred surgery; Patients without neoadjuvant treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with a diagnosis of colorectal cancer are eligible.

You may qualify if:

• Colorectal cancer

You may not qualify if:

• Not colorectal cancer

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Göteborg University: collaborator

Study Sites (1)

Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Gothenburg, SE 416 85, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biopsies prior and after treatment

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Eva Angenete

CONTACT

0760514441; eva.angenete@vgregion.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 18, 2019
• Study Start: February 1, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

SE (1)