Clinical trial NCT04726800: Circulating Tumour DNA (ctDNA) as a Prognostic and Predictive Marker in Colorectal Cancer - a Pilot Study
Official title: A Pilot Study Investigating the Feasibility to Perform Prospective Circulating Tumor DNA (ctDNA) Profiling in Patients With Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colorectal Cancer
Keywords: predictive marker
prognostic marker
ctDNA
colon cancer
rectal cancer
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Feasibility and logistics of measuring ctDNA
timeFrame: 2 years
measure: Frequency of positive ctDNA postoperatively in relation to tumour stage and oncological outcome.
timeFrame: 3 years
measure: Frequency of positive ctDNA preoperative converted to negative postoperatively.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Akershus Univeristy Hospital
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Skövde
country: Sweden
facility: Skaraborg Hospital
city: Stockholm
country: Sweden
facility: Capio Sankt Göran Hospital
city: Stockholm
country: Sweden
facility: Danderyd University Hospital
city: Stockholm
country: Sweden
facility: Ersta Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Stockholm
country: Sweden
facility: South Hospital
Study officials:
affiliation: Karolinska Institutet
name: Anna Martling, Professor
role: PRINCIPAL_INVESTIGATOR
References: