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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04726800
Recruitment Status : Active, not recruiting
First Posted : January 27, 2021
Last Update Posted : February 20, 2024
Sponsor:
Information provided by (Responsible Party):
Anna Martling, Karolinska Institutet

Study Description
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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.

Condition or disease
Colorectal Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study Investigating the Feasibility to Perform Prospective Circulating Tumor DNA (ctDNA) Profiling in Patients With Colorectal Cancer
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 ]

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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04726800


Locations
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Norway
Akershus Univeristy Hospital
Oslo, Norway
Sweden
Sahlgrenska University Hospital
Göteborg, 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
Sponsors and Collaborators
Anna Martling
Investigators
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Principal Investigator: Anna Martling, Professor Karolinska Institutet
More Information
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Responsible Party: Anna Martling, Professor, Senior Consultant Surgeon, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04726800    
Other Study ID Numbers: 2019-04884
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: February 20, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Martling, Karolinska Institutet:
predictive marker
prognostic marker
ctDNA
colon cancer
rectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases