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

Circulating Tumor Cells Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02781025
• Other study ID #: LCCC1604
• Status: Completed
• Start date: April 2016
• Est. completion date: December 30, 2020

Study information

• Verified date: December 2021
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

There are currently very few practical or reproducible model systems which recapitulate the metastatic process well. CTCs are important for the development of metastases and there is interest in isolating and culturing them ex vivo to better characterize their biology, metastatic potential, and response to different therapies. The investigators have previously demonstrated efficient capture and enumeration of CTCs in 4 unique patient cohorts (metastatic prostate and locally advanced rectal, cervical and head and neck cancers) in the investigators prospective clinical study, LCCC 1408 (Investigation of Circulating Tumor Cells from Cancer Patients Undergoing Radiation Therapy). However, CTCs are difficult to culture with conventional methods. The investigators propose to culture CTCs using novel decellularized tissue matrices. Blood will be collected from cancer patients with metastatic solid tissue tumors prior to starting definitive or palliative radiotherapy. The investigators will then isolate CTCs and attempt to grow them on various decellularized matrices. If this study is successful and feasibility is demonstrated, important pilot information will also be gathered which will then be used in power and sample size considerations for future CTCs studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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

• Male and female patients capable of reproduction must agree to use medically acceptable methods of contraception, such as an intra-uterine device, diaphragm, with spermicide, condom with spermicide or abstinence, during radiation therapy. Inclusion of females of childbearing potential requires a negative pregnancy test within 14 days prior to study initiation (part of standard of care in radiation oncology).

• Written informed consent obtained and signed

• Able to have blood collection without excessive difficulty

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Circulating Tumor Cells
• Neoplasm Metastasis
• Neoplastic Cells, Circulating

Intervention

Other:
• Blood draw
A blood sample of 10mL- 25mL will be collected before the start of radiation treatment.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill, Department of Radiation Oncology	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	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

External Links

•   UNC Lineberger Comprehensive Cancer Center