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

Neoplastic Cells, Circulating Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02412384
• Other study ID #: Lung Cancer CTC 001
• Status: Completed
• Phase: N/A
• First received: April 5, 2015
• Last updated: February 23, 2016
• Start date: June 2013
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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: ?,?,?

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neoplastic Cells, Circulating

Intervention

Other:
• Flow cytometry (FCM)
Use FCM to test PBMCs/CTCs from volunteers/patients.
• RT-PCR
Use RT-PCR to test PBMCs/CTCs from volunteers/patients.

Locations

Country	Name	City	State
China	Central laboratory in Fuda cancer hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou

Country where clinical trial is conducted

China, 

References & Publications (3)

Han Y, Su C, Liu Z. Methods for detection of circulating cells in non-small cell lung cancer. Front Biosci (Landmark Ed). 2014 Jun 1;19:896-903. Review. — View Citation

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. — View Citation

Yu N, Zhou J, Cui F, Tang X. Circulating tumor cells in lung cancer: detection methods and clinical applications. Lung. 2015 Apr;193(2):157-71. doi: 10.1007/s00408-015-9697-7. Epub 2015 Feb 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of Circulating Tumor Cells (CTCs)		Up to 6 month	Yes