Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
Study NCT ID:
NCT06290856
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Utility of Selected Circulating Tumor DNA Assays in Patients With Advanced Malignancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D018281', 'term': 'Cholangiocarcinoma'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma samples (STRECK tubes) prepared for cell free DNA extraction will be collected and frozen.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2024-02-26', 'studyFirstSubmitQcDate': '2024-02-26', 'lastUpdatePostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.'}], 'secondaryOutcomes': [{'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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['circulating tumor DNA'], 'conditions': ['Metastatic Colorectal Cancer', 'Pancreas Adenocarcinoma', 'Cholangiocarcinoma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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?\n\n•\n\nMetastatic 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?\n\nCan the information of liver metastases or prognostic markers (s-CEA, s-CRP) guide timing of ctDNA sampling?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Advanced malignancy', 'eligibilityCriteria': 'Inclusion Criteria:\n\nNewly 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.'}, 'identificationModule': {'nctId': 'NCT06290856', 'briefTitle': 'Clinical Utility of Selected Circulating Tumor DNA Assays in Patients With Advanced Malignancy', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Clinical Utility of Selected Circulating Tumor DNA Assays in Patients With Advanced Malignancy', 'orgStudyIdInfo': {'id': '651397'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Advanced gastrointestinal malignancy', 'description': 'Pancreatic cancer, Colorectal cancer, Cholangiocarcinoma', 'interventionNames': ['Diagnostic Test: Multiplex PCR-test for circulating tumor DNA']}], 'interventions': [{'name': 'Multiplex PCR-test for circulating tumor DNA', 'type': 'DIAGNOSTIC_TEST', 'description': 'All recruited patients will be tested for', 'armGroupLabels': ['Advanced gastrointestinal malignancy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Ragnhild Nome, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Oslo university Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'centralContacts': [{'name': 'Ragnhild Nome, MD, PhD', 'role': 'CONTACT', 'email': 'ragnom@ous-hf.no', 'phone': '98602658'}], 'overallOfficials': [{'name': 'Ragnhild Nome, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator. MD, PhD', 'investigatorFullName': 'Ragnhild Nome', 'investigatorAffiliation': 'Oslo University Hospital'}}}}