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The Detection of Circulating Tumor Cells (CTCs) in Patients With Breast Cancer Undergoing Cryosurgery Combined With DC-CIK Treatment

NCT ID: NCT02450357

Last Updated: 2015-12-30

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

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-12-31

Brief Summary

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Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in breast cancer could play an important role in diagnosis, predicting the risk for tumor recurrence, and providing novel target therapy biomarkers. In view of these facts, the investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting human tumor cells of breast cancer in normal peripheral blood after cryosurgery with or without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR) method.

Detailed Description

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1 day before and 2 days after cryosurgery with or without DC-CIK treatment，approximately 17-mL ethylene diamine tetraacetic acid(EDTA)-blood was drawn by vein puncture from patients with breast cancer and healthy volunteers. The blood of the healthy volunteers will be used to evaluate the sensitivity and specificity and as negative control cells. To avoid contamination with skin cells, 2 mL blood will be discarded before the study samples will be taken.Briefly, the mononucleate cells will be separated from the blood over Ficoll- Paque for 20 min with 1800g at 4℃. The interface cells will be removed and washed, and the red blood cells(RBCs) will be removed using a lysis buffer followed by a repeated wash. The mononuclear cells will be counted and aliquot for RT-PCR and multiparameter flow cytometry on the basis of at least 2-3×106 cells for each methodology. The cell pellet will be resuspended in phosphate-buffered saline for multiparameter flow cytometry and in Trizol reagent for RT-PCR. Aim : Identification of CTCs may lead to better diagnosis and prognosis and could help to choose an adequate therapy.

Conditions

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Neoplastic Cells, Circulating

Keywords

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Breast Neoplasms Circulating Tumor Cells

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Use Flow cytometry (FCM) and RT-PCR to test peripheral blood mononuclear cells(PBMCs) from healthy volunteer.

Flow cytometry (FCM)

Intervention Type OTHER

Use FCM to test PBMCs/CTCs from volunteers/patients.

RT-PCR

Intervention Type OTHER

Use RT-PCR to test PBMCs/CTCs from volunteers/patients.

Cryosurgery group

Use Flow cytometry (FCM) and RT-PCR to test CTCs from patients who received cryosurgery only, 1 day before and 2 days after the cryosurgery.

Flow cytometry (FCM)

Intervention Type OTHER

Use FCM to test PBMCs/CTCs from volunteers/patients.

RT-PCR

Intervention Type OTHER

Use RT-PCR to test PBMCs/CTCs from volunteers/patients.

DC-CIK treatment group

Use Flow cytometry (FCM) and RT-PCR to test CTCs from patients who received DC-CIK treatment only, 1 day before and 2 days after the DC-CIK treatment.

Flow cytometry (FCM)

Intervention Type OTHER

Use FCM to test PBMCs/CTCs from volunteers/patients.

RT-PCR

Intervention Type OTHER

Use RT-PCR to test PBMCs/CTCs from volunteers/patients.

Cryosurgery with DC-CIK treatment group

Use Flow cytometry (FCM) and RT-PCR to test CTCs from patients received cryosurgery and DC-CIK treatment both, 1 day before and 2 days after the cryosurgery with DC-CIK treatment.

Flow cytometry (FCM)

Intervention Type OTHER

Use FCM to test PBMCs/CTCs from volunteers/patients.

RT-PCR

Intervention Type OTHER

Use RT-PCR to test PBMCs/CTCs from volunteers/patients.

Interventions

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Flow cytometry (FCM)

Use FCM to test PBMCs/CTCs from volunteers/patients.

Intervention Type OTHER

RT-PCR

Use RT-PCR to test PBMCs/CTCs from volunteers/patients.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age:18-75
2. Karnofsky performance status \>60
3. Diagnosis of breast cancer based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Will receive cryosurgery and/or DC-CIK treatment
6. Life expectancy: Greater than 3 months
7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities
8. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria

1. Patients with other primary tumor except lung cancer
2. History of coagulation disorders or anemia
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fuda Cancer Hospital, Guangzhou

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Central laboratory in Fuda cancer hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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Wang HY, Ahn S, Kim S, Park S, Park S, Han H, Sohn JH, Kim S, Lee H. Detection of circulating tumor cells in patients with breast cancer using the quantitative RT-PCR assay for monitoring of therapy efficacy. Exp Mol Pathol. 2014 Dec;97(3):445-52. doi: 10.1016/j.yexmp.2014.09.003. Epub 2014 Sep 10.

Reference Type BACKGROUND
PMID: 25217799 (View on PubMed)

Other Identifiers

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Breast Cancer CTC 001

Identifier Type: -

Identifier Source: org_study_id