Validation of the MiCK Assay

Mesothelioma, Small Cell Lung Cancer, NSCLC Clinical Trial

— MiCK Assay  

Official title:

Mayo Clinic Validation of the MiCK Assay

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01770665
• Other study ID #: MAYO1000
• Status: Terminated
• Phase: N/A
• First received: January 16, 2013
• Last updated: September 14, 2016
• Start date: June 2012
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: DiaTech Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Mayo Clinic IRB
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: September 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mesothelioma
• Mesothelioma, Small Cell Lung Cancer, NSCLC
• Small Cell Lung Carcinoma

Locations

Country	Name	City	State
United States	Mayo Validation Support Services 3050 Superior Drive NW	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
DiaTech Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response and survival		1 year	No