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.

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Key information

Conditions

Neoplastic Cells, Circulating Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Central laboratory in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age:18-75
Karnofsky performance status >60
Diagnosis of pancreatic cancer based on histology or the current accepted radiological measures.
Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
Will receive cryosurgery and/or DC-CIK treatment
Life expectancy: Greater than 3 months
Patients' routine blood test, liver function and kidney function have no obvious abnormalities
Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion criteria

Patients with other primary tumor except pancreatic cancer
History of coagulation disorders or anemia

Treatment and study plan

Flow cytometry (FCM)

Other

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

RT-PCR

Other

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

Primary outcomes

The number of Circulating Tumor Cells (CTCs)

Time frame: Up to 6 month

Sponsors and collaborators

Lead sponsor

Fuda Cancer Hospital, Guangzhou

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Apr 2, 2015
Registry last updated: Dec 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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