TME RESEARCH

TME Retrospective Tissue Registry

Title

TME Retrospective Tissue Registry Project to Correlate Tumor Biomarkers with Clinical Outcomes

Rationale

The medical community is enthusiastically incorporating the use of molecular analysis of individual tumors to guide effective treatment options. To support and validate these anticipated advances, new molecular analyses must be carefully linked with de-identified clinical presentation, treatment and outcome data.
Understanding and accelerating the development of these tests is currently hindered by lack of available clinical annotated outcomes data, hence the significance of a retrospective database that includes a minimum of 5 years of follow up information.

Goal

  • Create an innovative virtual tissue bank that includes up to 2000 data sets consisting of tissue (FFPE blocks) matched with de-identified clinical data.
  • Associated clinical data includes disease characteristics and short and long term outcomes, such as tumor characteristics, staging, recurrence and death, in patients with a minimum follow-up of 5 years.
  • Aimed at molecular assay discovery and validation research.

 

Description

This multi-center, retrospective observational database is designed to collect de-identified data on the demographics, presentation, diagnosis, treatment, recurrence and ultimate outcomes of subjects and link these data with breast cancer tissue in FFPE blocks that can be utilized for molecular analyses.

Scope

  • All patients (living or deceased) previously diagnosed and treated for breast cancer treated a minimum of 5 years ago are eligible for inclusion; patients who have completed surgical treatment post neo-adjuvant therapy.
  • Initially, the registry will house subjects from small number of breast specialty practices, but will be expanded to include additional practices over time.
  • Tissue is housed at the pathology lab of origin.
  • Data is 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.
  • Registry active with start date of September 2014.

 

Sponsorship

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

For additional information, contact:

Peter Beitsch, MD
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TME research
Mary Kay Hardwick
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Project details

Tags: Retrospective Tissue Registry

 

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.