Validation of the MiCK Assay

NCT ID: NCT01770665

Last Updated: 2016-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Mesothelioma, Small Cell Lung Cancer, NSCLC

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mesothelioma

No interventions assigned to this group

all cancer types

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* patients that a sample cannot obtained for testing.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pierian Biosciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary Karaus

Role: STUDY_DIRECTOR

Mayo Clinic

Locations

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Mayo Validation Support Services 3050 Superior Drive NW

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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MAYO1000

Identifier Type: -

Identifier Source: org_study_id

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