Data Mining: Precision Analytical Retrospective Data Correlation

March 28, 2023 updated by: Precision Analytical, Inc.

Precision Analytical Retrospective Data Correlation

Data from previously analyzed clinical samples tested by Precision Analytical, Inc. will be mined to identify and select samples from patients reporting hormone supplement use. Patient demographics (BMI, for example), different therapies and expected changes in hormone levels will be analyzed and hormone metabolite patterns will be compared. Samples will be deidentified prior to analysis.

Study Overview

Status

Completed

Conditions

Detailed Description

The investigators have a list of 10 estrogen metabolites, 8 androgen metabolites, two progesterone metabolites, 4 cortisol metabolites, free cortisol, six organic acids, 8-hydroxy-2'-deoxyguanosine (8-OHdG), and melatonin that are measured on patient urine samples and cortisol and cortisone on patient saliva samples. The investigators would like to both reinforce the validation of the accuracy of these urinary markers and examine how these markers associate with patient demographics, symptoms, hormone therapy doses and routes of administration.

This study will involve analysis of existing data from routine clinical care. All data will be deidentified and each set of results will be given a study ID number. The key will be held by Danielle Martinot and will contain only the original Precision Analytical sample accession number and the new study ID (identification). No identifying PHI (Protected Health Information) will be accessible to the PI.

These data will be used to evaluate the following hypotheses: 1) Urinary hormone measures accurately reflect expected changes in hormones with regard to circadian rhythm, menstrual status, and use of hormonal medications; 2) Urinary metabolites of cortisol will show a stronger association with body mass index and symptoms related to cortisol production as compared to salivary measures; 3) Urine values of reproductive hormones and organic acids will correlate to the dosing of estrogen and androgens more strongly than to progesterone creams; 4) 8-OHdG, a measure of oxidative stress, and melatonin will be correlated with age and BMI; and 5) Urinary hormone measures will capture age-related changes in hormone regulation.

Study Type

Observational

Enrollment (Actual)

144561

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • McMinnville, Oregon, United States, 97128
        • Precision Analytical, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals between the ages of 18 and 85 years with data in the Precision Analytical database

Description

Inclusion Criteria:

  • Had testing done at Precision Analytical between 2016 and 2019

Exclusion Criteria:

  • Varies by data analysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Precision Analytical patients
Individuals who had laboratory work completed at Precision Analytical and completed the associated questionnaire on symptoms and comorbidities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI - weight and height will be combined to report BMI in kg/m2
Time Frame: 6 months
Relationship of BMI to cortisol production and clearance
6 months
Urinary hormonal profile including concentrations of estrone, estradiol, estriol, alpha-pregnanediol, and beta-pregnanediol
Time Frame: 6 months
Determination of urine estrogen and progesterone metabolites in postmenopausal women receiving hormonal treatment
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Precision Analytical, Inc.

Investigators

  • Principal Investigator: Mark Newman, MS, Precision Analytical, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2019

Primary Completion (Actual)

March 28, 2023

Study Completion (Actual)

March 28, 2023

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

March 9, 2020

First Posted (Actual)

March 12, 2020

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MN11819

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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