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Clinical Trials/NCT03161821
NCT03161821
Completed
Not Applicable

Quantification and Characterization of Circulating Tumor Cells in Solid Tumors

UNC Lineberger Comprehensive Cancer Center1 site in 1 country206 target enrollmentDecember 9, 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Solid Tumor, Adult
Sponsor
UNC Lineberger Comprehensive Cancer Center
Enrollment
206
Locations
1
Primary Endpoint
Documentation of the Quality of CTCs from Patients with Solid Tumors
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study is to identify circulating tumor cells in patients with solid tumors. Quantify and characterize these cells, collect patient information in regards to the patient's cancer. Develop a database and a sample repository where future analysis could be done.

Detailed Description

The primary purpose of this correlative study is to create a prospective database documenting the quantity and characterization of circulating tumor cells (CTCs) in solid tumor patients as identified by a various laboratory techniques and analyses. The investigators are developing this resource to provide data to achieve the following objectives: 1) correlate CTCs with known prognostic factors, 2) correlate CTCs with burden of disease, 3) evaluate the ability of CTCs to be used in the surveillance of disease recurrence, and 4) evaluate CTCs ability to be used as a biomarker for treatment response.

Registry
clinicaltrials.gov
Start Date
December 9, 2011
End Date
February 16, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years of age
  • Biopsy proven solid tumor malignancy
  • Seen at UNC Chapel Hill Hospital and Health Care System
  • Consents to abstraction of their medical records
  • Signed an institutional review board (IRB)-approved informed consent document for this protocol

Exclusion Criteria

  • \< 18 years of age
  • Dementia, altered mental status, incarceration or any psychiatric condition that would prohibit the understanding or rendering of informed consent.

Outcomes

Primary Outcomes

Documentation of the Quality of CTCs from Patients with Solid Tumors

Time Frame: Through study completion, an average of 5 years

Enumeration of participants' circulating solid tumor cells

Documentation of the Characterization of CTCs from Patients with Solid Tumors

Time Frame: Through study completion, an average of 5 years

Characterization of participants' circulating solid tumor cells

Study Sites (1)

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