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

Recruiting

• Conditions: C18; C19; C20; Malignant neoplasm of colon; Malignant neoplasm of rectosigmoid junction; Malignant neoplasm of rectum

• Registration Number: DRKS00017627
• Lead Sponsor: IVERSITÄTSKLINIKUM Freiburg - Klinik für Innere Medizin I - Hämatologie, Onkologie und Stammzelltransplantation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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<br>Explorative secondary endpoint in selected patients:<br>Detection of tumor-specific mutations in ctDNA isolated from plasma using NGS assays and relation to results of ddPCR