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

• Sponsor: Fuda Cancer Hospital, Guangzhou (Other)
• Overall Status: Completed
• CT.gov ID: NCT02450357
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Duration (Months): 30
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplastic Cells, Circulating	Other: Flow cytometry (FCM); Other: RT-PCR

Detailed Description

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Detection of Circulating Tumor Cells (CTCs) in Patients With Breast Cancer Undergoing Cryosurgery Combined With DC-CIK Treatment
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Control Use Flow cytometry (FCM) and RT-PCR to test peripheral blood mononuclear cells(PBMCs) from healthy volunteer.	Other: Flow cytometry (FCM); Use FCM to test PBMCs/CTCs from volunteers/patients.; Other: RT-PCR; 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.	Other: Flow cytometry (FCM); Use FCM to test PBMCs/CTCs from volunteers/patients.; Other: RT-PCR; 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.	Other: Flow cytometry (FCM); Use FCM to test PBMCs/CTCs from volunteers/patients.; Other: RT-PCR; 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.	Other: Flow cytometry (FCM); Use FCM to test PBMCs/CTCs from volunteers/patients.; Other: RT-PCR; Use RT-PCR to test PBMCs/CTCs from volunteers/patients.

Outcome Measures

Primary Outcome Measures

1. The number of Circulating Tumor Cells (CTCs) [Up to 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central laboratory in Fuda cancer hospital	Guangzhou	Guangdong	China	510665

Sponsors and Collaborators

• Fuda Cancer Hospital, Guangzhou

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Fuda Cancer Hospital, Guangzhou
• ClinicalTrials.gov Identifier: NCT02450357
• Other Study ID Numbers: Breast Cancer CTC 001
• First Posted: May 21, 2015
• Last Update Posted: Dec 30, 2015
• Last Verified: Dec 1, 2015

• Keywords provided by Fuda Cancer Hospital, Guangzhou: Breast Neoplasms; Circulating Tumor Cells
• Additional relevant MeSH terms: Neoplastic Cells, Circulating

Study Results

No Results Posted as of Dec 30, 2015