Clinical Utility of Selected Circulating Tumor DNA Assays in Patients With Advanced Malignancy

January 27, 2026 updated by: Ragnhild Nome, Oslo University Hospital
Circulating tumor DNA assays are becoming relevant for routine diagnostics, but many related aspects are yet unresolved. With this project, the investigators aim to develop pragmatic molecular diagnostic pathways of liquid biopsies relevant in advanced gastrointestinal malignancies with focus on clinical utility and sensible use of resources. They want to evaluate the ctDNA assays on a fully automated "low-cost" multiplex platform which is already implemented in routine molecular diagnostics of solid biopsies. The project will evaluate to what extent these ctDNA assays are relevant for clinical decision-making.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Advanced pancreatic cancer (PDAC) and cholangiocarcinoma (CCA): -Could the Idylla ctKRAS test select the ~10% of PDAC patients with KRASwt eligible for more extensive diagnostics? In PDAC and CCA, is it possible to detect patient samples with KRAS G12C or BRAF mutation for study inclusion? Could the ΔCq-value of the tests be used as a semi-quantitative tumor marker? What is the clinical value compared to the current tumor marker CA19-9?

•

Metastatic Colorectal Cancer: Are the ctDNA assays useful in detecting primary resistance and/or monitoring for secondary/acquired resistance to EGFR antibody treatment? How does the sensitivity, specificity and turnaround time of the ctDNA assays compare to tissue-based analysis? Could the Idylla ctDNA assays accelerate detection of KRAS G12C or BRAF mutations, and hence facilitate study inclusion in the first line setting? Could the ctDNA assays guide rechallenge with EGFR treatment?

Can the information of liver metastases or prognostic markers (s-CEA, s-CRP) guide timing of ctDNA sampling?

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Advanced malignancy

Description

Inclusion Criteria:

Newly referred patients with advanced pancreatic cancer (~20/year), Cholangiocarcinoma (~20/year), metastatic colorectal cancer (mCRC) (~50/year) and anti-EGFR-treated mCRC patients (~10/year) to Oslo University Hospital are eligible for inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Advanced gastrointestinal malignancy
Pancreatic cancer, Colorectal cancer, Cholangiocarcinoma
Diagnostic test: Multiplex PCR-test for circulating tumor DNA
All recruited patients will be tested for

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical validity of ctDNA tests
Time Frame: 1 week
Number of participants where the ctDNA results leads to changes in diagnostic work-up, treatment initiation or change of treatment.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resources needed for ctDNA assays in routine diagnostics
Time Frame: 1 week
Ratio of certain clinical features (i.e. location of metastasis; liver versus lung) or biochemical markers (elevated CRP, CEA etc versus normal markers) that is associated with a positive ctDNA result. The rationale is that ctDNA usually is higher with liver metastases compared to lung and that elevated biochemical markers are associated with more progressive disease and hence more inclined to give positive ctDNA results. Cost efficient use relies on positive ctDNA results as the opposite result is non-informative.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Ragnhild Nome, MD,PhD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Actual)

July 15, 2024

Study Completion (Actual)

July 15, 2024

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 651397

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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