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

NCT06290856 | Terminated

• 1 other identifier: 651397
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Colorectal Cancer; Pancreas Adenocarcinoma; Cholangiocarcinoma

Keywords

circulating tumor DNA

Outcome Measures

Primary Outcomes (1)

• 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.

  1 week

Secondary Outcomes (1)

• Resources needed for ctDNA assays in routine diagnostics

  1 week

Study Arms (1)

Advanced gastrointestinal malignancy

Pancreatic cancer, Colorectal cancer, Cholangiocarcinoma

Diagnostic Test: Multiplex PCR-test for circulating tumor DNA

Interventions

Multiplex PCR-test for circulating tumor DNA DIAGNOSTIC_TEST

All recruited patients will be tested for

Advanced gastrointestinal malignancy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Advanced malignancy

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo university Hospital

Oslo, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples (STRECK tubes) prepared for cell free DNA extraction will be collected and frozen.

MeSH Terms

Conditions

Colorectal Neoplasms; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Ragnhild Nome, MD,PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator. MD, PhD

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: January 15, 2024
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)