Metastatic Colorectal CancerNCT06290856
Clinical Utility of Selected Circulating Tumor DNA Assays in Patients With Advanced Malignancy
An observational study of Metastatic Colorectal Cancer and Pancreas Adenocarcinoma, run by Oslo University Hospital at 1 site in Norway.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, Pancreas Adenocarcinoma, Cholangiocarcinoma
- What is being tested?
- Multiplex PCR-test for circulating tumor DNA
- How many people
- 16 participants
- Where
- 1 siteNorway
- Study dates
- 15 Jan 2024to 15 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Advanced malignancy
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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?
- Being tested
- Multiplex PCR-test for circulating tumor DNA
- Keywords
- circulating tumor DNA
- Medical subject headings
- Colorectal Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiplex PCR-test for circulating tumor DNADiagnostic test
All recruited patients will be tested for
| Study group | Role | What they receive |
|---|---|---|
| Advanced gastrointestinal malignancy | Pancreatic cancer, Colorectal cancer, Cholangiocarcinoma Receives: Diagnostic Test: Multiplex PCR-test for circulating tumor DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical validity of ctDNA tests
Number of participants where the ctDNA results leads to changes in diagnostic work-up, treatment initiation or change of treatment.
Measured: 1 week
Secondary outcomes (1)
Resources needed for ctDNA assays in routine diagnostics
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start15 Jan 2024
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
Why it stopped: The platform used for detecting ctDNA was not sensitive enough.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragnhild Nome, Oslo University Hospital
- Investigators
- Ragnhild Nome, MD,PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290856
- Sponsor's protocol ID
- 651397
- Status last verified
- Jan 2026
- First submitted
- 26 Feb 2024
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of Selected Circulating Tumor DNA Assays in Patients With Advanced Malignancy
- ClinicalTrials.gov ID
- NCT06290856
- Acronym / sponsor ID
- 651397
- Keywords
- circulating tumor DNA
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The platform used for detecting ctDNA was not sensitive enough.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced gastrointestinal malignancy | – | Diagnostic Test: Multiplex PCR-test for circulating tumor DNAPancreatic cancer, Colorectal cancer, Cholangiocarcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced malignancy
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiplex PCR-test for circulating tumor DNAAll recruited patients will be tested for | Diagnostic test | Advanced gastrointestinal malignancy |
Primary outcome
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 secondary outcome
Resources needed for ctDNA assays in routine diagnostics
Time frame: 1 week
Results and safety
The study was stopped early (reason given: The platform used for detecting ctDNA was not sensitive enough.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Metastatic Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ragnhild Nome, MD,PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer and Pancreas Adenocarcinoma, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The platform used for detecting ctDNA was not sensitive enough.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical validity of ctDNA tests (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.