Circulating Tumor Cells in Solid Tumors

Completed

• Conditions: Solid Tumor, Adult

• Registration Number: NCT03161821
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2011-12-09
• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-22
• Primary Completion: 2021-02-16
• Study Completion: 2021-02-16
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Documentation of the Quality of CTCs from Patients with Solid Tumors	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	Through study completion, an average of 5 years	Characterization of participants' circulating solid tumor cells

Trial Locations

Locations (1)

Radiation Oncology Clinic - UNC Cancer Hospital; 🇺🇸 Chapel Hill, North Carolina, United States