The Detection of CTCs in Patients With Pancreatic 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 Pancreatic Cancer Undergoing Cryosurgery Combined With DC-CIK Treatment.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02406846
• Other study ID #: Pancreatic Cancer CTC 001
• Status: Completed
• Phase: N/A
• First received: March 30, 2015
• Last updated: December 28, 2015
• Start date: June 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational [Patient Registry]

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 pancreatic 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, We wanted to demonstrate the value of multiparameter flow cytometry in detecting human tumor cells of pancreatic cancer in normal peripheral blood after cryosurgery with or without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and we 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 pancreatic 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: 80
• Est. completion date: December 2015
• 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 pancreatic 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 pancreatic cancer

2. History of coagulation disorders or anemia

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neoplastic Cells, Circulating
• Pancreatic Neoplasms

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)

Hu Y, Fan L, Zheng J, Cui R, Liu W, He Y, Li X, Huang S. Detection of circulating tumor cells in breast cancer patients utilizing multiparameter flow cytometry and assessment of the prognosis of patients in different CTCs levels. Cytometry A. 2010 Mar;77( — View Citation

Li Z, Chen K, Jiang P, Zhang X, Li X, Li Z. CD44v/CD44s expression patterns are associated with the survival of pancreatic carcinoma patients. Diagn Pathol. 2014 Apr 8;9:79. doi: 10.1186/1746-1596-9-79. — View Citation

Tjensvoll K, Nordgård O, Smaaland R. Circulating tumor cells in pancreatic cancer patients: methods of detection and clinical implications. Int J Cancer. 2014 Jan 1;134(1):1-8. doi: 10.1002/ijc.28134. Epub 2013 Mar 25. Review. — View Citation

Outcome

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

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