FoundationOne™ Test Registry Study

NCT ID: NCT01851213

Last Updated: 2016-08-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 510 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2016-03-31

Brief Summary

This study is a prospective, multicenter, observational study to characterize utilization patterns of the FoundationOne™ test by oncologists under conditions of routine clinical practice in the US. The study will also examine impact of test results on subsequent clinical decisions regarding choice of therapy. The planned duration of the study is at least 2 years with 1 year for patient recruitment and a minimum 1-year follow-up period for each patient. Any patient for whom the treating physician has ordered a FoundationOne™ test and a report is delivered is eligible for participation on the study. Eligible patients from participating sites will be enrolled sequentially during the 1-year enrollment period. Sites will be required to maintain an enrollment log of all patients for whom the FoundationOne™ test has been ordered and document patient disposition and reasons for non-participation. All treatment decisions and clinical assessment will be made at the discretion of the treating physician per usual care and are not mandated by study design or protocol. Informed consent will be obtained from eligible patients prior to study entry.

Detailed Description

Molecular testing of tumors, using techniques such as next-generation sequencing (NGS), facilitates an individualized approach to cancer treatment by sub-classifying diseases on an individual basis. Physicians can utilize an in depth understanding of disease at a molecular level to optimize therapy by selecting the most appropriate drugs and therapeutic targets. Genomic profiling has identified multiple genomic aberrations that are predictive markers for treatment response with targeted therapeutics.

FoundationOne™ is a commercially available molecular diagnostics test, for all solid tumor types, that analyzes routine clinical specimens for somatic alterations in relevant cancer-related genes. This validated in vitro diagnostic test, is performed in a single Clinical Laboratory Improvement Amendments (CLIA) certified and College of American Pathologists (CAP) approved laboratory at Foundation Medicine, Inc. It provides individualized, potentially actionable information regarding a patient's molecular cancer subtype that can be used by physicians to tailor treatment options.

With the recent commercial availability of the FoundationOne™ test, knowledge gaps exist regarding practice patterns associated with the use of this test in routine clinical practice and the impact of this test on clinical decision making. There is limited information regarding physician and patient characteristics that determine which patients receive the test, rationale for patient selection, and how physicians interpret and use the test results. Findings from this study will help to optimize patient selection and maximize the clinical impact of the test in terms of guiding therapy.

Conditions

Cancer; Neoplasm Metastasis; Tumor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

FoundationOne™ Test Ordered

Patients for whom a FoundationOne™ test was ordered and a report is delivered.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

The FoundationOne test was ordered by the treating physician under routine clinical practice

• Age ≥ 18 years
• Patient willing and able to provide informed consent
• Informed consent date is at least one day prior to the FoundationOne test report date

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Quintiles, Inc.

INDUSTRY

Sponsor Role: collaborator

Foundation Medicine

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary Palmer, MD

Role: PRINCIPAL_INVESTIGATOR

Sr VP Medical Afairs

Locations

Evergreen Hematology/Oncology

Spokane, Washington, United States

Countries

United States

Other Identifiers

FMI-001-NGS-500

Identifier Type: -

Identifier Source: org_study_id