TME RESEARCH

Genetic Testing Registry Platform

Title 

Genetic Testing Registry Platform

Rationale

Over time multi-gene germ-line tests are expected to replace single or two-gene testing for patients determined to be at significant risk for hereditary breast and ovarian cancers.
To accomplish the goal of improving health management of patients, multi-gene germ-line diagnostic testing must be integrated into clinical practice without causing harm. While test accuracy is critical, the major concerns with the implementation of expanded multi-gene panels include utilization in appropriate patients, effective pre- and post-test counseling and well-informed choice of risk management options.

Goal

Provide a platform to encourage private practice and academic physicians to collaborate in gathering information that will document safety, utility, clinical impact and patient experience of new multi-gene germ line tests for breast and ovarian cancer risk in clinical practice. 

Description

This prospective observational registry will document safety, utility, clinical impact and patient experience for patients identified at risk and obtaining multi-gene germ-line tests. 

Scope

  • All patients who have been identified as being appropriate for cancer risk genetic testing and who have or have had multi-gene panel testing will be included.
  • Approximately 20-50 breast specialty practices in the US will be invited to contribute patient data and up to 1000 patients will be enrolled over 2-4 years.
  • Data will be captured electronically for ease of data entry and access.
  • Scientific advisory board oversight.
  • IRB approval from E&I IRB Services, Corte Madera, CA or via local institution.
  • Start date:  December 2014.
  • Spin-off project: Clinical Consultant Services evaluation study (http://www.invitae.com)  

 

Why should I participate?

  • Help define standard of care and best practices in use of multi-gene testing to guide risk management and patient care.
  • Ready access to practice data for insight, quality control, publication and community presentations.
  • Gain insight into how other practices are utilizing these tests and with what success.
  • Ready access to data to support utilization and reimbursement of these tests.
  • Participate in multi-institution publications.

 

Sponsorship

Funded initially via a research grant from TME.  Future sponsorship may include additional industry and professional society support. 

For additional information, contact:

Pat Whitworth, MD
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TME research
Mary Kay Hardwick
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Project details

Tags: Genetic Testing Registry Platform

 

What is TME Research?

TME Research is an extension of the TME mission to improve quality and access to emerging technologies and best practices in breast cancer prevention, diagnosis, treatment and patient care.

We are a partnership of community leading practitioners and experienced researchers who design, execute and drive enrollment in Registries that collect the real world experience and data that support the adoption of emerging technologies.
Extensive experience in publication helps us turn raw data into insight, analysis, publications and presentation.

TME Research registries provide an opportunity for research partnerships with industry.

 

Introducing a significant investment in turnkey registries

These Registries target areas of significant interest in breast cancer with the aim of supporting development, understanding and adoption of emerging technologies.  Jointly funded by TME and industry.

 

 

Why should you participate in one of our registries?



  • Help define standard of care and best practices
  • Ready access to individual practice data for insight, quality control, publication and community presentations
  • Gain insight into how other practices are utilizing new technologies and with what success
  • Access to data to support utilization and reimbursement
  • Participate in multi-institution publications
Can I really implement a research Registry in my practice?

TME designs the Registry, creates the electronic tools for collecting and providing you access to the data, and trains and supports implementation in your practice.