Validation of the MiCK Assay

Terminated

• Conditions: Mesothelioma, Small Cell Lung Cancer, NSCLC

• Registration Number: NCT01770665
• Lead Sponsor: Pierian Biosciences

Brief Summary

Testing Mayo Clinic cancer patients with the results being correlated with prior patient therapy, performance status, and extent of disease.

Detailed Description

This study will be conducted in two phases.

During the Feasibility Phase, specimens from any tumor will be sent to the central DiaTech MiCK assay laboratory to determine the ease of sample acquisition, processing, transport, and assay interpretation.

Once DiaTech has completed analyses for the feasibility phase specimens and has confirmed that the sample acquisition, processing, transport, and assay interpretation are appropriate, we will proceed with the Demonstration Phase.

During the Mesothelioma Demonstration Phase, 20 mesothelioma samples will be assayed and the results will be correlated with prior patient therapy, performance status, and extent of disease.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-01-16
• Study First Submitted QC: 2013-01-16
• Study First Posted: 2013-01-18
• Primary Completion: 2015-01
• Status Verified: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-14
• Last Update Posted: 2016-09-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• 20 subjects diagnosed with mesothelioma and 10 diagnosed with any malignancy.

Exclusion Criteria

• patients that a sample cannot obtained for testing.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete response and survival	1 year

Trial Locations

Locations (1)

Mayo Validation Support Services 3050 Superior Drive NW; 🇺🇸 Rochester, Minnesota, United States