Healthcare Decisions Post-Testing, Risk-reducing and Preventative Strategies Using LYNCH Genetic Testing Reducing, and Preventative Strategies Using LYNCH Genetic Testing

January 22, 2019 updated by: Data Collection Analysis Business Management

Medical Provider Experience Assessment Healthcare Decisions Post-Testing, Risk-Reducing, and Preventative Strategies Using LYNCH Genetic Testing

Increase surveillance for LYNCH Syndrome

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The purpose of this minimal risk, observational survey is to increase surveillance for Lynch Syndrome (hereditary non-polyposis colon cancer), Colorectal, and Endometrial cancer, also to determine targeted risk-reducing and preventative strategies.

Study Type

Observational

Enrollment (Anticipated)

200

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
    • Florida
      • Land O' Lakes, Florida, United States, 33558
        • DCABM

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 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

collecting data and reviewing the Principal Investigators' (P.I.) Standard Operating Procedures (SOP) on Lynch genetic testing and changes made to their specific SOP.

Description

Inclusion Criteria:

  • Must be a Medical Practitioner

    • Medical Doctor (MD)
    • Doctor of Osteopathic (DO)
    • Physician Assistant (PA)
    • Advanced Practice Registered Nurse (APRN)
    • Nurse Practitioner (NP)
  • Must have a current standard operating procedure that includes obtaining/reviewing medical history and family medical history.

Exclusion Criteria:

  • Government-funded insurance data cannot be included in the study.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Provider Structures and Processes
Time Frame: 36 months
Plan of Care Changes due to LYNCH genetic testing. Provider based observational survey system on the health and well-being of patients and populations
36 months

Collaborators and Investigators

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

Sponsor

Data Collection Analysis Business Management

Collaborators

PAS Research Services

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)

October 17, 2017

Primary Completion (Anticipated)

October 17, 2020

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

October 24, 2017

First Submitted That Met QC Criteria

October 25, 2017

First Posted (Actual)

October 26, 2017

Study Record Updates

Last Update Posted (Actual)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 22, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAS1461

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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