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

NCT ID: NCT02781025

Last Updated: 2021-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2020-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Circulating Tumor Cells

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Blood draw

Intervention Type OTHER

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

Interventions

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Blood draw

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Wang, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Related Links

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http://unclineberger.org/

UNC Lineberger Comprehensive Cancer Center

Other Identifiers

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LCCC1604

Identifier Type: -

Identifier Source: org_study_id