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

NCT04726800 | Active Not Recruiting DMC

• 1 other identifier: 2019-04884
• Study Type: observational
• Target: 300
• Locations: 2 countries
• Sites: 8

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.

Conditions

Colorectal Cancer

Keywords

predictive marker; prognostic marker; ctDNA; colon cancer; rectal cancer

Outcome Measures

Primary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anna Martling: lead

Study Sites (8)

Akershus Univeristy Hospital

Oslo, Norway

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Skaraborg Hospital

Skövde, Sweden

Location

Capio Sankt Göran Hospital

Stockholm, Sweden

Location

Danderyd University Hospital

Stockholm, Sweden

Location

Ersta Hospital

Stockholm, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

South Hospital

Stockholm, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Participants will be asked to donate 30ml blood before surgery (baseline), after surgery at 4-6 weeks, 3-, 6-, 12- and 24 months postoperatively to measure cell-free DNA (cfDNA) in plasma. All biospecimens will be shipped to the biobank at Karolinska Institutet for further processing. DNA will be extracted from tumor tissue and whole blood. Targeted sequencing of tumor tissue and germline DNA will be performed using in solution hybridization-based capture at Clinical Genomics, SciLife Lab, Stockholm. Blood in the CITCCA pilot will be profiled prospectively with a two-week turnover, using the ProBio infrastructure, mimicking a real clinical scenario where minimal residual disease (MRD) information will be available in a condense report format.

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Anna Martling, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Senior Consultant Surgeon

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 27, 2021
• Study Start: October 1, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

SE (7); NO (1)