FoundationOne™ Test Registry Study

NCT01851213 | Completed

• 1 other identifier: FMI-001-NGS-500
• Study Type: observational
• Target: 510
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Neoplasm Metastasis; Tumor

Keywords

genomics; cancer; registry; neoplasm metastasis

Outcome Measures

Primary Outcomes (1)

• Composite characterization of current real-world practice patterns in the use of the FoundationOne™ test and the effect of the FoundationOne™ test on clinical decision making across the US

  Characterization of practice patterns for the use of the test described by: * Provider and site characteristics of patients receiving the FoundationOne test * Socio-demographic and clinical characteristics of patients receiving the FoundationOne test Examination of the effect of the test on clinical decision making by describing: * Subsequent treatment patterns for patients after receipt of test results * Clinician report outcomes regarding how test results guided clinical decision making

  Minimum 1 year follow-up

Secondary Outcomes (1)

• Exploratory endpoints describing clinical outcomes in the study population

  Minimum 1 year follow-up

Study Arms (1)

FoundationOne™ Test Ordered

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This Pilot Study will aim to enroll approximately 500 patients from a total of 40 oncology centers in the US over a 1-year time period. Any patient for whom the treating physician has ordered the FoundationOne test is eligible for inclusion in the study. In order to capture real-world treatment patterns, site recruitment will aim to include approximately 80% of sites (and 80% of patients) from the community oncology setting. Enrollment will be competitive and each site will be capped at a maximum of 15 patients.

You may qualify if:

• 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

Sponsors & Collaborators

• Foundation Medicine: lead
• Quintiles, Inc.: collaborator

Study Sites (1)

Evergreen Hematology/Oncology

Spokane, Washington, 99218, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gary Palmer, MD

  Sr VP Medical Afairs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: May 10, 2013
• Study Start: March 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 9, 2016

Record last verified: 2016-08

Locations

US (1)