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Comprehensive Gene Sequencing in Guiding Treatment Recommendations Patients With Metastatic or Recurrent Solid Tumors

NCT01987726 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2021-10-28

No results posted yet for this study

Summary

This pilot clinical trial studies comprehensive gene sequencing in guiding treatment recommendations in patients with metastatic or recurrent solid tumors. Studying samples of blood and tissue from patients with cancer in the laboratory may improve the ability to plan treatment.

Conditions

  • Recurrent Breast Cancer
  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Stage IV Breast Cancer
  • Stage IVA Colon Cancer
  • Stage IVA Rectal Cancer
  • Stage IVB Colon Cancer
  • Stage IVB Rectal Cancer

Interventions

OTHER

cytology specimen collection procedure

Undergo collection of CTCs for NGS and FMI testing, respectively.The most recent tumor sample collected from the patient with enough tissue to perform NGS testing will be selected. Tumor from a metastatic or recurrent cancer lesion is preferred but not required. Tumor collection is for standard of care purposes and thus not detailed in this protocol.For each tissue specimen, a representative H\&E stained section will be evaluated by a qualified pathologist to confirm the histopathological diagnosis of cancer and to make a quantitative estimate of the proportion of the specimen that is tumor-related cells and the proportion that is non-tumor cells.

OTHER

laboratory biomarker analysis

2 tubes of 7.5 mL blood samples each will be collected at time tumor tissue is sent to FMI and sent to Cynvenio Biosystems, Inc for CTC isolation and analysis. Patient CTCs will be recovered using Cynvenio CTC flow cell technology (Cynvenio Biosystems, Inc.) and enumerated using a combination of CD45, DAPI and cytokeratin staining.1 DNA will be isolated from CTCs and amplified using Φ-29 whole genome amplification (GE Healthcare). Sequencing to be performed by FoundationOne™ protocol.

Sponsors & Collaborators

  • Foundation Medicine

    collaborator INDUSTRY

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Maryam Lustberg, MD · Ohio State University Comprehensive Cancer Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-03
Primary Completion
2021-06-10
Completion
2021-06-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01987726 on ClinicalTrials.gov