Clinical trial · Observational
Clinical Utility of Selected Circulating Tumor DNA Assays in Patients With Advanced Malignancy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The platform used for detecting ctDNA was not sensitive enough.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Pancreas Adenocarcinoma | Pancreatic Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multiplex PCR-test for circulating tumor DNA | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Advanced gastrointestinal malignancy
- description
- Pancreatic cancer, Colorectal cancer, Cholangiocarcinoma
- interventionNames
- Diagnostic Test: Multiplex PCR-test for circulating tumor DNA
Primary outcomes (1)
- measure
- Clinical validity of ctDNA tests
- timeFrame
- 1 week
- description
- Number of participants where the ctDNA results leads to changes in diagnostic work-up, treatment initiation or change of treatment.
Secondary outcomes (1)
- measure
- Resources needed for ctDNA assays in routine diagnostics
- timeFrame
- 1 week
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available