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Circulating Tumor Cells in Solid Tumors

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ClinicalTrials.gov Identifier: NCT03161821
Recruitment Status : Suspended (New enrollment and collection of blood samples paused while IRB reviews use of the investigational assay involved.)
First Posted : May 22, 2017
Last Update Posted : December 24, 2020
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment
Solid Tumor, Adult Other: Observational

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 Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Quantification and Characterization of Circulating Tumor Cells in Solid Tumors
Actual Study Start Date : December 9, 2011
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with cancerous solid tumors
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03161821


Locations
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United States, North Carolina
Radiation Oncology Clinic - UNC Cancer Hospital
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
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Principal Investigator: Gaorav P Gupta, MD, MPH University of North Carolina
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03161821    
Other Study ID Numbers: LCCC 1121
11-1924 ( Other Identifier: UNC IRB )
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplastic Cells, Circulating
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes