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RecruitingNCT04130971PredictUpdated Nov 7, 2023

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

An observational study in Colorectal Neoplasms, sponsored by Sahlgrenska University Hospital. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-07.

Sponsored by Sahlgrenska University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Feb 2019; still recruiting 7 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Neoplasms
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 800 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Sahlgrenska University Hospital is the lead sponsor of 259 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients with a diagnosis of colorectal cancer are eligible.

Inclusion criteria

  • Colorectal cancer

Exclusion criteria

Exclusion Criteria:

  • Not colorectal cancer
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • OtherNo intervention, just observation

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

06

What researchers measure

Primary outcomes

  1. Tumour response to treatment

    Tumour microenviroment changes

    Time frame: 1-2 months after initiated treatment

Secondary outcomes

  1. Normal tissue response to treatment

    Extra cellular matrix changes

    Time frame: 1month -3 years after treatment

07

Study locations

1 of 1 sites recruiting
  • Dept. of Surgery, Sahlgrenska University Hospital/Ostra
    Gothenburg, SE 416 85, Sweden
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04130971
Lead sponsor
Sahlgrenska University Hospital
Collaborators
Göteborg University
Responsible party
Eva Angenete (PI, Sahlgrenska University Hospital) — Principal investigator
First posted
Oct 18, 2019
Start date
Feb 1, 2019
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Nov 7, 2023

Study contacts

Eva Angenete
Contact
eva.angenete@vgregion.se
0760514441

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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