Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06290856
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-26
Brief Title:
Clinical Utility of Selected Circulating Tumor DNA Assays in Patients With Advanced Malignancy
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Clinical Utility of Selected Circulating Tumor DNA Assays in Patients With Advanced Malignancy
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 andor monitoring for secondaryacquired 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
Metastatic Colorectal Cancer Are the ctDNA assays useful in detecting primary resistance andor monitoring for secondaryacquired 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None