Feasibility study of biomarker development for response prediction by large scale DNA mutational analysis of metastatic lesions.

Completed

• Conditions: metastatic cancer; metastatic solid tumors; 10017991

• Registration Number: NL-OMON39548
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

Metastatic colorectal carcinoma or other solid tumors
Failed at least one line of palliative chemotherapy
Irinotecan naïve
Eligible, as per local protocol, for palliative treatment with standard of care irinotecan
Measurable metastatic lesion(s) according to RECIST 1.1. criteria
Safe biopsy of a radiological measurable lesion possible
Adults age 18 years or up
Written informed consent

Exclusion Criteria

Patients with other malignancies than metastatic colorectal cancer or other solid tumors
Patients eligible for first-line treatment
Patients who were already subjected to treatment with irinotecan
Patients with disease not measurable according to RECIST 1.1. criteria
Safe biopsy of radiological measurable lesion not possible
Patients younger than 18 years old
Patients not willing to sign informed consent

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Exploration of the correlation between percentage change in volumetric<br /><br>measurement of the index lesion and the mutational profile after the first two<br /><br>cycles of chemotherapy.</p><br>