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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02412384
Enrollment
120
Registered
2015-04-09
Start date
2013-06-30
Completion date
2016-02-29
Last updated
2016-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplastic Cells, Circulating

Keywords

Lung Neoplasms, Circulating Tumor Cells

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 lung 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 lung 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

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 lung 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.

Interventions

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

OTHERRT-PCR

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

Sponsors

Fuda Cancer Hospital, Guangzhou
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

1. Age:18-75 2. Karnofsky performance status \>60 3. Diagnosis of lung 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

Design outcomes

Primary

MeasureTime frame
The number of Circulating Tumor Cells (CTCs)Up to 6 month

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026