Validation of the MiCK Assay

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2013 by DiaTech Oncology.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
DiaTech Oncology Identifier:
First received: January 16, 2013
Last updated: April 18, 2014
Last verified: January 2013
Testing Mayo Clinic cancer patients with the results being correlated with prior patient therapy, performance status, and extent of disease.

Mesothelioma, Small Cell Lung Cancer, NSCLC

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Mayo Clinic Validation of the MiCK Assay

Resource links provided by NLM:

Further study details as provided by DiaTech Oncology:

Primary Outcome Measures:
  • Complete response and survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Human cancerous tumor.

Estimated Enrollment: 30
Study Start Date: June 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
all cancer types

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
20 subjects diagnosed with mesothelioma and 10 diagnosed with any malignancy.

Inclusion Criteria:

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

Exclusion Criteria:

  • patients that a sample cannot obtained for testing.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01770665

Contact: Mary Karaus 507-538-8472

United States, Minnesota
Mayo Validation Support Services 3050 Superior Drive NW Recruiting
Rochester, Minnesota, United States, 55901
Contact: Mary Karaus    507-538-8472   
Principal Investigator: Julian Molina, MD, PhD         
Principal Investigator: Dennis Wigle, MD, PhD         
Sponsors and Collaborators
DiaTech Oncology
Study Director: Mary Karaus Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: DiaTech Oncology Identifier: NCT01770665     History of Changes
Other Study ID Numbers: MAYO1000
Study First Received: January 16, 2013
Last Updated: April 18, 2014
Health Authority: United States: Mayo Clinic IRB

Additional relevant MeSH terms:
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Mesothelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms processed this record on November 30, 2015