NCT01855061

Biomarker Development for Response Prediction by DNA Mutational Analysis

Feasibility Study of Biomarker Development for Response Prediction by Large Scale DNA Mutational Analysis of Metastatic Lesions

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 79 (actual)
• Sponsor: P.O. Witteveen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether it is possible to predict response to chemotherapy in patients with metastatic cancer who are treated with irinotecan by determining the mutational profile of the tumor.

Conditions

• Neoplasm Metastasis

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Histological biopsy of the "index lesion" (a radiological measurable lesion on which biopsy is performed) at baseline, as well as when showing progressive disease. Histological biopsies will be subjected to DNA sequencing to assess the mutational profile, as well as to analysis of carboxylesterase activity.
PROCEDURE	Blood samples	Blood samples will be taken at baseline to determine patient's genetic background variation (germline DNA).
PROCEDURE	Pharmacokinetics	Blood samples will be taken for pharmacokinetic analysis of the active irinotecan metabolite (SN-38).
PROCEDURE	Midazolam clearance test	Patients who are being treated in Rotterdam will be subjected to blood draws for validation of the earlier developed midazolam phenotyping test (midazolam clearance test), which may be an indicator for pharmacokinetics of irinotecan.

Timeline

• Start date: 2011-05-01
• Primary completion: 2015-11-01
• Completion: 2016-08-01
• First posted: 2013-05-16
• Last updated: 2018-03-09

Locations

3 sites across 1 country: Netherlands