Circulating Tumor DNANCT02620527
Concordance Between ctDNA Assay and FoundationOne
An observational study of Circulating Tumor DNA and Cancer, run by Foundation Medicine at 1 site in United States.
Trial summary
Foundation Medicine Inc. (FMI) is interested in studying the concordance of genomic alterations between primary and/or metastatic surgical biopsies, and circulating tumor DNA (ctDNA) within different solid tumor types and has been developing an assay in order to do so. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Circulating Tumor DNA, Cancer, Neoplasms
- How many people
- 1,400 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Dec 2017
- 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: Patients diagnosed with cancer and who have had a solid tumor biopsy isolated for analysis by FoundationOne
Who may be able to join
- Patients who have had a solid tumor biopsy isolated for analysis by FoundationOne under their standard clinical care
Who cannot join
- Tumor specimens where no cancer representative of the diagnosis is found in submitted tissue
- Tumor specimens where insufficient DNA (<50 ng) is provided to run the FoundationOne test.
- Tumor specimens with ≤20% tumor nuclei (all specimens).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Concordance Between Circulating Tumor DNA Assay and Foundation One Tissue Analysis For Genomic Alterations
Foundation Medicine Inc. (FMI) is interested in studying the concordance of genomic alterations between primary and/or metastatic surgical biopsies, and circulating tumor DNA (ctDNA) within different solid tumor types and has been developing an assay in order to do so.
Read the detailed description
The purpose of this study is to assess whether a new ctDNA assay developed by Foundation Medicine is able to detect genomic alterations in peripheral blood that are consistent with the genomic alterations detected in a patient's matched primary and/or metastatic tumor biopsy sample analyzed by the FoundationOne® test. Study sites will provide matched solid tumor and peripheral blood samples of cancer patients to FMI for the purpose of testing the concordance of the FMI ctDNA assay to the FoundationOne® test. Participation in this study is part of a broader 2000 patient study to determine which tumor types are most readily measured via ctDNA profiling, and to learn of the similarity between the alterations found in a patient's tumor biopsy and the ctDNA from their blood.
- Conditions
- Circulating Tumor DNA, Cancer, Neoplasms, Genomic Testing, Genomic Alterations
- Keywords
- Circulating Tumor DNA, Cancer, Neoplasms, Genomic Testing, FoundationOne, Cell Free DNA, ctDNA, cfDNA
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether new ctDNA assay can detect genomic alterations in peripheral blood that are consistent with those detected by FoundationOne in matched solid tumor samples
Measured: 6-12 months
Determine which tumor types are most amenable to detection using peripheral blood ctDNA assay
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Circulating Tumor DNAStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation Medicine
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University, Oncology Consultants, Comprehensive Blood and Cancer Center, Illinois CancerCare, Sanford Health, Eastchester Center for Cancer Care, Rutgers Cancer Institute of New Jersey, Cone Health, Nebraska Cancer Specialists, University of California, Davis, University of Chicago, Northeast Georgia Medical Center, Hematology Oncology Associates of Fredericksburg, Memorial Sloan Kettering Cancer Center, Oncology Hematology Care, Inc, Montefiore Medical Center, Quincy Medical Group, Prisma Health-Upstate, Mary Crowley Cancer Research Center, Texas Health, University of California, San Diego, Avera Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Phil Stephens, PhD, Principal investigator, Foundation Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620527
- Sponsor's protocol ID
- FMI-CTDNA-15
- Status last verified
- Jul 2018
- First submitted
- 1 Dec 2015
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhou C, Yuan Z, Ma W, Qi L, Mahavongtrakul A, Li Y, Li H, Gong J, Fan RR, Li J, Molmen M, Clark TA, Pavlick D, Frampton GM, Forcier B, Moore EH, Shelton DK, Cooke M, Ali SM, Miller VA, Gregg JP, Stephens PJ, Li T. Clinical utility of tumor genomic profiling in patients with high plasma circulating tumor DNA burden or metabolically active tumors. J Hematol Oncol. 2018 Nov 6;11(1):129. doi: 10.1186/s13045-018-0671-8.
PubMed 30400986
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Concordance Between Circulating Tumor DNA Assay and Foundation One Tissue Analysis For Genomic Alterations
- ClinicalTrials.gov ID
- NCT02620527
- Acronym / sponsor ID
- FMI-CTDNA-15
- Conditions
- Circulating Tumor DNA, Cancer, Neoplasms, Genomic Testing, Genomic Alterations
- Keywords
- Circulating Tumor DNA, Cancer, Neoplasms, Genomic Testing, FoundationOne, Cell Free DNA, ctDNA, cfDNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- Foundation MedicineIndustry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University, Oncology Consultants, Comprehensive Blood and Cancer Center, Illinois CancerCare, Sanford Health, Eastchester Center for Cancer Care, Rutgers Cancer Institute of New Jersey, Cone Health, Nebraska Cancer Specialists, University of California, Davis, University of Chicago, Northeast Georgia Medical Center, Hematology Oncology Associates of Fredericksburg, Memorial Sloan Kettering Cancer Center, Oncology Hematology Care, Inc, Montefiore Medical Center, Quincy Medical Group, Prisma Health-Upstate, Mary Crowley Cancer Research Center, Texas Health, University of California, San Diego, Avera Cancer Institute
- Study start
- Nov 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 Dec 2015 (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.
Foundation Medicine Inc. (FMI) is interested in studying the concordance of genomic alterations between primary and/or metastatic surgical biopsies, and circulating tumor DNA (ctDNA) within different solid tumor types and has been developing an assay in order to do so.
Detailed description
The purpose of this study is to assess whether a new ctDNA assay developed by Foundation Medicine is able to detect genomic alterations in peripheral blood that are consistent with the genomic alterations detected in a patient's matched primary and/or metastatic tumor biopsy sample analyzed by the FoundationOne® test. Study sites will provide matched solid tumor and peripheral blood samples of cancer patients to FMI for the purpose of testing the concordance of the FMI ctDNA assay to the FoundationOne® test. Participation in this study is part of a broader 2000 patient study to determine which tumor types are most readily measured via ctDNA profiling, and to learn of the similarity between the alterations found in a patient's tumor biopsy and the ctDNA from their blood.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with cancer and who have had a solid tumor biopsy isolated for analysis by FoundationOne
Key inclusion criteria (1 listed)
- Patients who have had a solid tumor biopsy isolated for analysis by FoundationOne under their standard clinical care
Key exclusion criteria (3 listed)
- Tumor specimens where no cancer representative of the diagnosis is found in submitted tissue
- Tumor specimens where insufficient DNA (<50 ng) is provided to run the FoundationOne test.
- Tumor specimens with ≤20% tumor nuclei (all specimens).
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
Whether new ctDNA assay can detect genomic alterations in peripheral blood that are consistent with those detected by FoundationOne in matched solid tumor samples
Time frame: 6-12 months
Determine which tumor types are most amenable to detection using peripheral blood ctDNA assay
Time frame: 6-12 months
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 1 Aug 2018.
- Derived from this study: PubMed 30400986Zhou C, Yuan Z, Ma W, Qi L, Mahavongtrakul A, Li Y, Li H, Gong J, Fan RR, Li J, Molmen M, Clark TA, Pavlick D, Frampton GM, Forcier B, Moore EH, Shelton DK, Cooke M, Ali SM, Miller VA, Gregg JP, Stephens PJ, Li T. Clinical utility of tumor genomic profiling in patients with high plasma circulating tumor DNA burden or metabolically active tumors. J Hematol Oncol. 2018 Nov 6;11(1):129. doi: 10.1186/s13045-018-0671-8.
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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.
Phil Stephens, PhD principal investigator
Foundation Medicine
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 Circulating Tumor DNA and Cancer, 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 1 inclusion and 3 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 1 Aug 2018. 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?
Whether new ctDNA assay can detect genomic alterations in peripheral blood that are consistent with those detected by FoundationOne in matched solid tumor samples (time frame: 6-12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02620527, which also lists 1 linked publication.
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 1 Aug 2018.