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

A Pilot Study Investigating the Feasibility to Perform Prospective Circulating Tumor DNA (ctDNA) Profiling in Patients With Colorectal Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04726800

Acronym

CITCCA

Enrollment

300

Registered

2021-01-27

Start date

2020-10-01

Completion date

2026-12-01

Last updated

2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

predictive marker, prognostic marker, ctDNA, colon cancer, rectal cancer

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

* 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

Design outcomes

Primary

Measure	Time frame
Feasibility and logistics of measuring ctDNA	2 years
Frequency of positive ctDNA postoperatively in relation to tumour stage and oncological outcome.	3 years
Frequency of positive ctDNA preoperative converted to negative postoperatively.	3 years

Countries

Norway, Sweden

Contacts

PRINCIPAL_INVESTIGATORAnna Martling, Professor

Karolinska Institutet

Outcome results