Culture of Circulating Tumor Cells Isolated From Cancer Patients With Metastatic Disease

NCT02781025 | Completed DMC

• 1 other identifier: LCCC1604
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the feasibility of using novel decellularized tissue matrices to isolate and culture circulating tumor cells (CTCs) collected from patients with metastatic solid tumor malignancies.

Conditions

Circulating Tumor Cells

Outcome Measures

Primary Outcomes (1)

• The proportion of successful CTC culture growths.

  The proportion of successful CTC culture growths will be calculated

  through study completion, an average of 6 months

Study Arms (1)

Oligometastatic Disease

Patients with oligometastatic cancer, defined as biopsy proven disease involving at least one organ other than the primary tumor organ. Regional lymph node metastases are not considered metastatic.

Other: Blood draw

Interventions

Blood draw OTHER

A blood sample of 10mL- 25mL will be collected before the start of radiation treatment.

Oligometastatic Disease

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing radiation treatments at Lineberger Comprehensive Cancer Center at UNC Hosptials for treatments of oligometastatic cancer.

You may qualify if:

• Patients with any metastatic solid tumor malignancy. Metastatic is defined as biopsy proven disease involving at least one organ other than the primary tumor organ. Regional lymph node metastases are not considered metastatic. Patients with newly diagnosed metastatic disease who have not had systemic therapy in at least six months or are progressing on systemic therapy will be eligible for enrollment.
• Scheduled to initiate radiation for management of their disease, and schedule accommodates blood sample collection prior to radiation
• Male and female of ≥18 years of age
• Written informed consent obtained and signed
• Able to have blood collection without excessive difficulty

You may not qualify if:

• Patient unwilling or unable to complete informed consent
• Physical or psychological inability to complete sample collection for any reason including but not limited to: inability to tolerate any study procedures, any physical limitation that would undermine the safety of the subject in the study, or any psychiatric or neurological condition that inhibits full comprehension of study requirements and inability to complete informed consent, as determined by treating physician
• Currently pregnant or lactating women

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

University of North Carolina at Chapel Hill, Department of Radiation Oncology

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• UNC Lineberger Comprehensive Cancer Center

MeSH Terms

Conditions

Neoplastic Cells, Circulating

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Andrew Wang, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 24, 2016
• Study Start: April 1, 2016
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: December 22, 2021

Record last verified: 2021-12

Locations

US (1)