NCT02620527

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

3.1 years

First QC Date

December 1, 2015

Last Update Submit

July 31, 2018

Conditions

Circulating Tumor DNACancerNeoplasmsGenomic TestingGenomic Alterations

Keywords

Circulating Tumor DNACancerNeoplasmsGenomic TestingFoundationOneCell Free DNActDNAcfDNA

Outcome Measures

Primary Outcomes (2)

  • Whether new ctDNA assay can detect genomic alterations in peripheral blood that are consistent with those detected by FoundationOne in matched solid tumor samples

    6-12 months

  • Determine which tumor types are most amenable to detection using peripheral blood ctDNA assay

    6-12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with cancer and who have had a solid tumor biopsy isolated for analysis by FoundationOne

You may qualify if:

  • Patients who have had a solid tumor biopsy isolated for analysis by FoundationOne under their standard clinical care

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation Medicine

Cambridge, Massachusetts, 02141, United States

Location

Related Publications (1)

  • 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.

    PMID: 30400986DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Phil Stephens, PhD

    Foundation Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2015

First Posted

December 3, 2015

Study Start

November 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

August 1, 2018

Record last verified: 2018-07

Locations

US(1)