Pilot study to evaluate the significance of detection of mutated, free circulating tumor DNA in adult patients with RAS wild-type and mutant colorectal cancer

Pilot study to evaluate the significance of detection of mutated, free circulating tumor DNA in adult patients with RAS wild-type and mutant colorectal cancer - ARTUR

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00017627

Enrollment

Registered

2019-07-10

Start date

2018-09-14

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C18 C19 C20

Interventions

Group 1: Colorectal Cancer, RAS wild-type and mutant, localized and metastatic Index test: Detection and quantitation of ctDNA using multiplex ddPCR using a custom panel of genes most frequently mutat

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed colorectal cancer 2. Localized or metastatic disease 3. Primary diagnosis or relapse or progression 4. Tissue sample available for mutation analysis at screening

Exclusion criteria

Exclusion criteria: Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix and basal or squamous cell carcinoma of the skin

Design outcomes

Primary

Measure	Time frame
Detection (yes/no) of tumor-specific mutations by multiplex ddPCR in ctDNA isolated from plasma for patients with and without tumor-specific mutations detected in tumor tissue	—

Secondary

Measure	Time frame
Response to treatment assessed by routine follow-up imaging studies, Routine biomarker assessment (CEA, CA19-9), progression-free survival and Overall survival and relation to preceding dynamic changes in the amount of ctDNA harboring tumor mutations Explorative secondary endpoint in selected patients: Detection of tumor-specific mutations in ctDNA isolated from plasma using NGS assays and relation to results of ddPCR	—

Measure

Time frame

Response to treatment assessed by routine follow-up imaging studies, Routine biomarker assessment (CEA, CA19-9), progression-free survival and Overall survival and relation to preceding dynamic changes in the amount of ctDNA harboring tumor mutations Explorative secondary endpoint in selected patients: Detection of tumor-specific mutations in ctDNA isolated from plasma using NGS assays and relation to results of ddPCR

—

Countries

Germany

Contacts

Public ContactNikolas von Bubnoff

UNIVERSITÄTSKLINIKUM - Schleswig-Holstein - Klinik für Hämatologie und Onkologie - Campus Lübeck

Nikolas.vonBubnoff@uksh.de0451 – 500 44151

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026