The Detection Of CTCs In Patients With Pancreatic Cancer Undergoing Cryosurgery Combined With DC-CIK Treatment.

Study Overview

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

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.

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.

Neoplastic Cells, Circulating

OTHER: Flow cytometry (FCM)
OTHER: RT-PCR

Pancreatic Cancer CTC 001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-03-30	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-12-28
First Submitted that Met QC Criteria 2015-04-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-12-30
First Posted (ESTIMATED) 2015-04-02	Results First Posted N/A	Last Verified 2015-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/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.

Primary Outcome Measures	Measure Description	Time Frame
The number of Circulating Tumor Cells (CTCs)		Up to 6 month

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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General Publications

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(3):213-9. doi: 10.1002/cyto.a.20838.
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.
Tjensvoll K, Nordgard 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.

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