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NCT03161821 Clinical Trial

Circulating Tumor Cells in Solid Tumors

Solid Tumor, Adult Clinical Trial

Official title:
Quantification and Characterization of Circulating Tumor Cells in Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03161821
Other study ID # LCCC 1121
Secondary ID 11-1924
Status Completed
Phase
First received
Last updated
Start date December 9, 2011
Est. completion date February 16, 2021

Study information
Verified date September 2022
Source UNC Lineberger Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 206
Est. completion date February 16, 2021
Est. primary completion date February 16, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Observational

Locations
Country Name City State
United States Radiation Oncology Clinic - UNC Cancer Hospital Chapel Hill North Carolina

Sponsors (1)
Lead Sponsor Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Documentation of the Quality of CTCs from Patients with Solid Tumors Enumeration of participants' circulating solid tumor cells Through study completion, an average of 5 years
Primary Documentation of the Characterization of CTCs from Patients with Solid Tumors Characterization of participants' circulating solid tumor cells Through study completion, an average of 5 years
See also
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Active, not recruiting NCT04474470 - A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer Phase 1/Phase 2
Recruiting NCT06088004 - Phase Ⅰ/Ⅱ Clinical Study to Evaluate ABO2011 Monotherapy in Advanced Solid Tumors Phase 1/Phase 2
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Recruiting NCT06144671 - GT201 Injection For The Treatment Of Advanced Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT06398418 - R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid Tumors Phase 1
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Recruiting NCT04121442 - Isunakinra Alone and in Combination With a PD-1/PD-L1 Inhibitor in Patients With Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04221204 - A Monotherapy in Subjects With Advanced Solid Tumors Phase 1
Terminated NCT03992326 - Adoptive Transfer Of Autologous Tumor-Infiltrating Lymphocytes in Solid Tumors Phase 1
Terminated NCT05435339 - A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy Phase 1/Phase 2
Recruiting NCT04981119 - Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Recruiting NCT06075849 - Phase I Study to Evaluate Safety and Anti-tumor Activity of PB101, an Anti-angiogenic Immunomodulating Agent Phase 1

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