CancerFMI RegistryNCT01851213
FoundationOne™ Test Registry Study
An observational study of Cancer and Neoplasm Metastasis, run by Foundation Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Neoplasm Metastasis, Tumor
- How many people
- 510 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Mar 2016
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- There are no exclusion criteria for this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Evergreen Hematology/Oncology
Spokane, Washington, 99218
About this study
Official title: A Prospective Observational Study to Examine, in Routine Clinical Practice in the US, Practice Patterns and Impact on Clinical Decision Making Associated With the FoundationOne™ Next Generation Sequencing (NGS) Test
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.
Read the 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
- Keywords
- genomics, cancer, registry, neoplasm metastasis
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| FoundationOne™ Test Ordered | Patients for whom a FoundationOne™ test was ordered and a report is delivered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Minimum 1 year follow-up
Secondary outcomes (1)
Exploratory endpoints describing clinical outcomes in the study population
- Overall survival
- 1-year survival
- Overall progression-free survival (PFS)
Measured: Minimum 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 510 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Foundation Medicine
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Gary Palmer, MD, Principal investigator, Sr VP Medical Afairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851213
- Sponsor's protocol ID
- FMI-001-NGS-500
- Acronym
- FMI Registry
- Status last verified
- Aug 2016
- First submitted
- 6 May 2013
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study to Examine, in Routine Clinical Practice in the US, Practice Patterns and Impact on Clinical Decision Making Associated With the FoundationOne™ Next Generation Sequencing (NGS) Test
- ClinicalTrials.gov ID
- NCT01851213
- Acronym / sponsor ID
- FMI Registry / FMI-001-NGS-500
- Conditions
- Cancer, Neoplasm Metastasis, Tumor
- Keywords
- genomics, cancer, registry, neoplasm metastasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 510 participants (actual)
- Lead sponsor
- Foundation MedicineIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Mar 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 10 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FoundationOne™ Test Ordered | – | –Patients for whom a FoundationOne™ test was ordered and a report is delivered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: Minimum 1 year follow-up
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
1 secondary outcome
Exploratory endpoints describing clinical outcomes in the study population
Time frame: Minimum 1 year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Palmer, MD principal investigator
Sr VP Medical Afairs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Neoplasm Metastasis, run by Foundation Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Minimum 1 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2016.