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Completed

NCT Number: NCT03161821

Circulating Tumor Cells in Solid Tumors

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.

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Key information

Conditions

Solid Tumor, Adult

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radiation Oncology Clinic - UNC Cancer Hospital

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational

Other

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Official study title

Quantification and Characterization of Circulating Tumor Cells in Solid Tumors

Important dates

Study start
2011
Primary completion
2021
Study completion
2021
First posted
May 22, 2017
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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