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Recruiting NCT04130971

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

Observational Colorectal Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention, just observation.
Who it may be relevant to
Registry conditions: Colorectal Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Tumour response to treatment [Time frame: 1-2 months after initiated treatment]
Secondary outcome measures (1)
  • Normal tissue response to treatment [Time frame: 1month -3 years after treatment]

Eligibility criteria

Inclusion criteria

  • Colorectal cancer

Exclusion criteria

  • Not colorectal cancer

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Dept. of Surgery, Sahlgrenska University Hospital/Ostra — Gothenburg

Identifiers

NCT: NCT04130971 · Predict

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗