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Validation of the MiCK Assay (MiCK Assay)

This study has been terminated.
(Assay being revised and re-validated.)
Information provided by (Responsible Party):
DiaTech Oncology Identifier:
First received: January 16, 2013
Last updated: September 14, 2016
Last verified: September 2016
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.

Enrollment: 21
Study Start Date: June 2012
Study Completion Date: September 2016
Primary Completion Date: January 2015 (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   (Adult, Senior)
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

United States, Minnesota
Mayo Validation Support Services 3050 Superior Drive NW
Rochester, Minnesota, United States, 55901
Sponsors and Collaborators
DiaTech Oncology
Study Director: Mary Karaus Mayo Clinic
  More Information

Responsible Party: DiaTech Oncology Identifier: NCT01770665     History of Changes
Other Study ID Numbers: MAYO1000 
Study First Received: January 16, 2013
Last Updated: September 14, 2016
Health Authority: United States: Mayo Clinic IRB

Additional relevant MeSH terms:
Small Cell Lung Carcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial processed this record on October 20, 2016