CClinicalTrials.gg
Active, not recruitingNCT04726800CITCCAUpdated Aug 21, 2026

Circulating Tumour DNA (ctDNA) as a Prognostic and Predictive Marker in Colorectal Cancer - a Pilot Study

An observational study in Colorectal Cancer, sponsored by Anna Martling. Active, not recruiting at 8 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Anna Martling · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 80 Years
Sex
All
01

Study summary

In clinical practice, there are currently no biomarkers that can guide colorectal cancer treatment in the primary and curative setting. Improved biomarker-based adjuvant treatments would be of greatest value in order to reduce the risk of relapse. There are reasons to believe that measurements of circulating tumor DNA (ctDNA) in plasma could be used to monitor minimal residual disease after surgery. To address this question, a pilot study was conducted with the purpose to demonstrate the feasibility to perform prospective profiling of ctDNA in a cohort of patients with colorectal cancer stage I-III using the already created Nordic infrastructure for clinical research built up for the ALASCCA trial. If the pilot study proves successful, a large randomised controlled Nordic multicenter study is planned where patients with positive ctDNA 4-6 weeks after radical surgery will be randomised to chemotherapy and/or a biologic agent.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • predictive marker
  • prognostic marker
  • ctDNA
  • colon cancer
  • rectal cancer
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.

This study's planned enrollment of 300 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Anna Martling is the lead sponsor of 2 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The pilot study will include patients diagnosed with colorectal cancer stage I-III invited to participate in the ALASCCA study.

Inclusion criteria

  • Colon or rectal cancer tumor stage I-III planned for radical surgery
  • Clean Colonoscopy or Computed Tomography (CT) colon within 3 months preoperatively or postoperatively but before randomization
  • Patient able to understand and sign written informed consent

Exclusion criteria

Exclusion Criteria:

  • Distant metastases
  • Other cancers (excluding colorectal cancer or other skin cancer than melanoma) within 3 years from screening
  • Significant medical illness that would interfere with study participation
  • Pregnancy or breastfeeding females
  • Current participation in another clinical trial that will be in conflict with the present study
  • Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Feasibility and logistics of measuring ctDNA

    Time frame: 2 years

  2. Frequency of positive ctDNA postoperatively in relation to tumour stage and oncological outcome.

    Time frame: 3 years

  3. Frequency of positive ctDNA preoperative converted to negative postoperatively.

    Time frame: 3 years

07

Study locations

8 sites
  • Akershus Univeristy Hospital
    Oslo, Norway
  • Sahlgrenska University Hospital
    Gothenburg, Sweden
  • Skaraborg Hospital
    Skövde, Sweden
  • Capio Sankt Göran Hospital
    Stockholm, Sweden
  • Danderyd University Hospital
    Stockholm, Sweden
  • Ersta Hospital
    Stockholm, Sweden
  • Karolinska University Hospital
    Stockholm, Sweden
  • South Hospital
    Stockholm, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04726800
Lead sponsor
Anna Martling
Responsible party
Anna Martling (Professor, Senior Consultant Surgeon, Karolinska Institutet) — Sponsor-investigator
First posted
Jan 27, 2021
Start date
Oct 1, 2020
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Aug 21, 2026

Study contacts

Anna Martling, Professor
principal investigator · Karolinska Institutet

Oversight

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

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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