NCT02406846

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

2.5 years

First QC Date

March 30, 2015

Last Update Submit

December 28, 2015

Conditions

Keywords

Pancreatic NeoplasmsCirculating Tumor Cells

Outcome Measures

Primary Outcomes (1)

  • The number of Circulating Tumor Cells (CTCs)

    Up to 6 month

Study Arms (4)

Control

Use Flow cytometry (FCM) and RT-PCR to test peripheral blood mononuclear cells(PBMCs) from healthy volunteer.

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

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)Other: RT-PCR

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)Other: RT-PCR

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)Other: RT-PCR

Interventions

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

ControlCryosurgery groupDC-CIK treatment groupcryosurgery with DC-CIK treatment group
RT-PCROTHER

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

ControlCryosurgery groupDC-CIK treatment groupcryosurgery with DC-CIK treatment group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Ⅱ,Ⅲ,Ⅳ stage pancreatic cancer come to Fuda Hospital for treatment.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central laboratory in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

Location

Related 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(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.

Related Links

MeSH Terms

Conditions

Neoplastic Cells, CirculatingPancreatic Neoplasms

Interventions

Flow CytometryReverse Transcriptase Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Cell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalInvestigative TechniquesPolymerase Chain ReactionNucleic Acid Amplification TechniquesGenetic Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 2, 2015

Study Start

June 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 30, 2015

Record last verified: 2015-12

Locations