NCT02450357

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 breast 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, the investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting human tumor cells of breast cancer in normal peripheral blood after cryosurgery with or without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators 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
60

participants targeted

Target at P25-P50 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
2 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
6 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

May 19, 2015

Last Update Submit

December 28, 2015

Conditions

Neoplastic Cells, Circulating

Keywords

Breast NeoplasmsCirculating Tumor Cells

Outcome Measures

Primary Outcomes (1)

  • The number of Circulating Tumor Cells (CTCs)

    Up to 6 months

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

Flow cytometry (FCM)OTHER

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

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

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

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

Eligibility Criteria

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

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

You may qualify if:

  • Age:18-75
  • Karnofsky performance status \>60
  • Diagnosis of breast 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 lung 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, 510665, China

Location

Related Publications (1)

  • Wang HY, Ahn S, Kim S, Park S, Park S, Han H, Sohn JH, Kim S, Lee H. Detection of circulating tumor cells in patients with breast cancer using the quantitative RT-PCR assay for monitoring of therapy efficacy. Exp Mol Pathol. 2014 Dec;97(3):445-52. doi: 10.1016/j.yexmp.2014.09.003. Epub 2014 Sep 10.

    PMID: 25217799BACKGROUND

MeSH Terms

Conditions

Neoplastic Cells, CirculatingBreast Neoplasms

Interventions

Flow CytometryReverse Transcriptase Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2015

First Posted

May 21, 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

CN(1)