- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02406846
The Detection of CTCs in Patients With Pancreatic Cancer Undergoing Cryosurgery Combined With DC-CIK Treatment.
December 28, 2015 updated by: Fuda Cancer Hospital, Guangzhou
The Detection of Circulating Tumor Cells (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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 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.
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Guangdong
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Guangzhou, Guangdong, China, 510000
- Central laboratory in Fuda cancer hospital
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-
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.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with Ⅱ,Ⅲ,Ⅳ stage pancreatic cancer come to Fuda Hospital for treatment.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control
Use Flow cytometry (FCM) and RT-PCR to test peripheral blood mononuclear cells(PBMCs) from healthy volunteer.
|
Use FCM to test PBMCs/CTCs from volunteers/patients.
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.
|
Use FCM to test PBMCs/CTCs from volunteers/patients.
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.
|
Use FCM to test PBMCs/CTCs from volunteers/patients.
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.
|
Use FCM to test PBMCs/CTCs from volunteers/patients.
Use RT-PCR to test PBMCs/CTCs from volunteers/patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of Circulating Tumor Cells (CTCs)
Time Frame: Up to 6 month
|
Up to 6 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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.
Helpful Links
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 Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
March 30, 2015
First Submitted That Met QC Criteria
April 1, 2015
First Posted (Estimate)
April 2, 2015
Study Record Updates
Last Update Posted (Estimate)
December 30, 2015
Last Update Submitted That Met QC Criteria
December 28, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pancreatic Cancer CTC 001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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