Validation of the MiCK Assay

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by DiaTech Oncology
Sponsor:
Information provided by (Responsible Party):
DiaTech Oncology
ClinicalTrials.gov Identifier:
NCT01770665
First received: January 16, 2013
Last updated: April 18, 2014
Last verified: January 2013
  Purpose

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


Condition
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)
Groups/Cohorts
Mesothelioma
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.

  Eligibility

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.

Criteria

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 ClinicalTrials.gov identifier: NCT01770665

Contacts
Contact: Mary Karaus 507-538-8472 karaus.mary@mayo.edu

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

Additional Information:
No publications provided

Responsible Party: DiaTech Oncology
ClinicalTrials.gov 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:
Lung Neoplasms
Mesothelioma
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on July 29, 2014