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Evaluation of Primex's PGX Assay to Assess the Clinical Utility of Pharmacogenomics

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ClinicalTrials.gov Identifier: NCT02336269
Recruitment Status : Recruiting
First Posted : January 12, 2015
Last Update Posted : January 12, 2015
Sponsor:
Collaborator:
Research & Development Institute, Inc.
Information provided by (Responsible Party):
Primex Clinical Laboratories, Inc.

Brief Summary:
Primex's PGX assay is an in vitro, semi automated assay, intended for the determination of certain genes involved in drug metabolism utilizing buccal swabs. Detection of certain genotypes is used as an aid in the selection of appropriate medications based on the individuals' specific genotype and should be used in conjunction with other clinical information. The results from this tests constitutes one parameter in a multicriterion medication selection process, encompassing both clinical and laboratory-based assessments.

Condition or disease
Patients on Medications Metabolized Via CYP450

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 100000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Protocol For The Evaluation of Primex's PGX Assay
Study Start Date : October 2013
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2019



Primary Outcome Measures :
  1. Clinical Utility of Primex's PGX assay as measured by medication change/no-change by the physician based on Primex's PGX assay results as an aid in the prediction of drug response [ Time Frame: 6 Months ]

Biospecimen Retention:   Samples With DNA
Buccal swab


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

A minimum of 10,000 buccal swab samples will be identified for inclusion in the study as follows:

  • A minimum of 8700 specimens from subjects who are on multiple medications of which at least 2 are affected by the pathways tested and the physician made changed to their drug regimen based on the assay interpretations
  • A minimum of 5200 specimens from subjects who are on multiple medications of which at least 2 are affected by the pathways tested and the physician made no changes based on the assay interpretations
  • A minimum of 1100 apparently healthy subjects.

Study subjects may be enrolled prospectively, from collection sites.

Criteria

Inclusion Criteria:

  • Buccal swab sample prospectively collected under Informed Consent
  • Remnant Buccal swab sample meeting the FDA requirements for use of leftover specimen
  • Samples from at least one of the following groups:
  • specimens from subjects who are on multiple medications of which at least 2 are affected by the pathways tested and the physician made changed to their drug regimen based on the assay interpretations
  • subjects who are on multiple medications of which at least 2 are affected by the pathways tested and the physician made no changes based on the assay interpretations
  • Subjects with Chronic disease
  • Subjects with different ethnic backgrounds
  • Subjects from different geographical areas
  • Apparently healthy subjects
  • Clinical information required per CRF is available

Exclusion Criteria:

- Samples that do not meet all inclusion criteria


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336269


Contacts
Contact: Zohrab Bostanian, MS 8182244235 zbostanian@rdi-web.com
Contact: Erik Avaniss Aghajani 8187790496 erik@primexlab.com

Locations
United States, California
Research and Development Institute Recruiting
Van Nuys, California, United States, 91406
Contact: Zohrab Bostanian, MS    818-224-4235    zbostanian@rdi-web.com   
Sponsors and Collaborators
Primex Clinical Laboratories, Inc.
Research & Development Institute, Inc.

Responsible Party: Primex Clinical Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT02336269     History of Changes
Other Study ID Numbers: RDI-PGX-80801.01
First Posted: January 12, 2015    Key Record Dates
Last Update Posted: January 12, 2015
Last Verified: January 2015

Keywords provided by Primex Clinical Laboratories, Inc.:
Pharmacogenomics