Patients on Medications Metabolized Via CYP450NCT02336269
Evaluation of Primex's PGX Assay to Assess the Clinical Utility of Pharmacogenomics
An observational study of Patients on Medications Metabolized Via CYP450, run by Primex Clinical Laboratories, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patients on Medications Metabolized Via CYP450
- How many people
- 100,000 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- Subjects with different ethnic backgrounds
- Subjects from different geographical areas
- Apparently healthy subjects
- Clinical information required per CRF is available
Who cannot join
- Samples that do not meet all inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Research and Development Institute
Van Nuys, California, 91406
Zohrab Bostanian, MS, 818-224-4235, zbostanian@rdi-web.com
About this study
Official title: Protocol For The Evaluation of Primex's PGX Assay
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.
Read the detailed description
The way a person responds to a drug (this includes both positive and negative reactions) is a complex trait that is influenced by many different genes. Without knowing all of the genes involved in drug response, scientists have found it difficult to develop genetic tests that could predict a person's response to a particular drug. Once scientists discovered that people's genes show small variations (or changes) in their nucleotide (DNA base) content, all of that changed-genetic testing for predicting drug response is now possible. Pharmacogenomics is a science that examines the inherited variations in genes that dictate drug response and explores the ways these variations can be used to predict whether a patient will have a good response to a drug, a bad response to a drug, or no response at all.
The Gene super family of Cytochrome P450 is primarily responsible for clearance of the different drugs and variations in different genes affect the metabolism of different classes of drugs. In our test we have concentrated on the genes and specific variations of those genes which have been studied best and already have existing and convincing data by peer reviewed journals.
Since one of the major classes of drugs that are affected by the Cytochrome P450 pathway are anti-coagulants, we have also added certain genes that are involved in coagulation variations of which might have additive affects on the coagulation status of the patient. Having this information can aid the physician in making better decisions when prescribing or dosing anti-coagulants.
Description of the Primex PGX Assay:
DNA is isolated from subject buccal swabs and is subjected to PCR and Real Time PCR for determination of the genetic variations detailed above. After the variations are determined, known effects of the variations (i.e. reduced activity or hyperactivity) are reported to a pharmacist and these effects in combination with the subjects medication list are used to further establish clinical significance or utility. The physician then can make a decision to change the medication as recommended. If the physician makes any changes to the subject's medication regimen, then in 3 months he/she will assess the changes and reports the findings; hence establishment of the clinical utility of our test.
Analytical Performance Objectives:
Assess the reproducibility of Primex's PGX assay with samples run in replicates of 3, twice a day, for a minimum 5 days.
Clinical Performance Evaluation Objectives:
Assess the clinical performance characteristics of Primex's PGX assay for the genotypes determined in the different genes of the CYP450 gene super family and genes related to coagulation by Life Technology's QuantSudio 12kFlex open array real time PCR system. There are no predicate devices therefore the clinical utility will be assessed by predicted phenotype and the number of effective changes made by the physicians to the subject's drug regimen.
Acceptance criteria for comparison of the Primex's PGX assay results to clinical changes made to the subject's drug regimen:
The clinical sensitivity and specificity of the Primex's PGX assay results to clinical changes made are a minimum of 65% and 90%, respectively. Results of the prior drug regimen changes before Primex's PGX testing will be provided and may be used for comparative analysis.
Investigator Feedback:
At the conclusion of the clinical study, the investigator will assess the clinical performance characteristics evaluated and acceptability of the Primex's PGX assay in a written report/letter to the sponsor.
- Keywords
- Pharmacogenomics
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study startOct 2013
- Primary completionOct 2017 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients on Medications Metabolized Via CYP450Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Primex Clinical Laboratories, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Research & Development Institute, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336269
- Sponsor's protocol ID
- RDI-PGX-80801.01
- Status last verified
- Jan 2015
- First submitted
- 5 Jan 2015
- Last updated
- 12 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol For The Evaluation of Primex's PGX Assay
- ClinicalTrials.gov ID
- NCT02336269
- Acronym / sponsor ID
- RDI-PGX-80801.01
- Keywords
- Pharmacogenomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Primex Clinical Laboratories, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Research & Development Institute, Inc.
- Study start
- Oct 2013
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 12 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The way a person responds to a drug (this includes both positive and negative reactions) is a complex trait that is influenced by many different genes. Without knowing all of the genes involved in drug response, scientists have found it difficult to develop genetic tests that could predict a person's response to a particular drug. Once scientists discovered that people's genes show small variations (or changes) in their nucleotide (DNA base) content, all of that changed-genetic testing for predicting drug response is now possible. Pharmacogenomics is a science that examines the inherited variations in genes that dictate drug response and explores the ways these variations can be used to predict whether a patient will have a good response to a drug, a bad response to a drug, or no response at all.
The Gene super family of Cytochrome P450 is primarily responsible for clearance of the different drugs and variations in different genes affect the metabolism of different classes of drugs. In our test we have concentrated on the genes and specific variations of those genes which have been studied best and already have existing and convincing data by peer reviewed journals.
Since one of the major classes of drugs that are affected by the Cytochrome P450 pathway are anti-coagulants, we have also added certain genes that are involved in coagulation variations of which might have additive affects on the coagulation status of the patient. Having this information can aid the physician in making better decisions when prescribing or dosing anti-coagulants.
Description of the Primex PGX Assay:
DNA is isolated from subject buccal swabs and is subjected to PCR and Real Time PCR for determination of the genetic variations detailed above. After the variations are determined, known effects of the variations (i.e. reduced activity or hyperactivity) are reported to a pharmacist and these effects in combination with the subjects medication list are used to further establish clinical significance or utility. The physician then can make a decision to change the medication as recommended. If the physician makes any changes to the subject's medication regimen, then in 3 months he/she will assess the changes and reports the findings; hence establishment of the clinical utility of our test.
Analytical Performance Objectives:
Assess the reproducibility of Primex's PGX assay with samples run in replicates of 3, twice a day, for a minimum 5 days.
Clinical Performance Evaluation Objectives:
Assess the clinical performance characteristics of Primex's PGX assay for the genotypes determined in the different genes of the CYP450 gene super family and genes related to coagulation by Life Technology's QuantSudio 12kFlex open array real time PCR system. There are no predicate devices therefore the clinical utility will be assessed by predicted phenotype and the number of effective changes made by the physicians to the subject's drug regimen.
Acceptance criteria for comparison of the Primex's PGX assay results to clinical changes made to the subject's drug regimen:
The clinical sensitivity and specificity of the Primex's PGX assay results to clinical changes made are a minimum of 65% and 90%, respectively. Results of the prior drug regimen changes before Primex's PGX testing will be provided and may be used for comparative analysis.
Investigator Feedback:
At the conclusion of the clinical study, the investigator will assess the clinical performance characteristics evaluated and acceptability of the Primex's PGX assay in a written report/letter to the sponsor.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- Samples that do not meet all inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients on Medications Metabolized Via CYP450, run by Primex Clinical Laboratories, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zohrab Bostanian, MS (8182244235, zbostanian@rdi-web.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2015.