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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Anna Martling
• Investigators: Principal Investigator: Anna Martling, Professor, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: rectal cancer; colon cancer; ctDNA; predictive marker; prognostic marker
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2019-04884

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No