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CompletedNCT02412384Updated Feb 25, 2016

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

An observational study in Neoplastic Cells, Circulating, sponsored by Fuda Cancer Hospital, Guangzhou. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-25.

Sponsored by Fuda Cancer Hospital, Guangzhou · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 75 Years
Sex
All
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Study 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 lung 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 lung 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.

Read the 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 lung 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.

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Conditions studied

  • Neoplastic Cells, Circulating

Keywords

  • Lung Neoplasms
  • Circulating Tumor Cells
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In context

Neoplastic Cells, Circulating

240 studies on the registry are indexed under Neoplastic Cells, Circulating; 52 are open to participants now.

This study's enrollment of 120 is close to the median of 113 across 138 observational studies indexed under Neoplastic Cells, Circulating.

Browse Neoplastic Cells, Circulating studies →

Lead sponsor

Fuda Cancer Hospital, Guangzhou is the lead sponsor of 113 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Patients with other primary tumor except lung cancer
  2. History of coagulation disorders or anemia
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherFlow cytometry (FCM)

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

  • OtherRT-PCR

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

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What researchers measure

Primary outcomes

  1. The number of Circulating Tumor Cells (CTCs)

    Time frame: Up to 6 month

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Study locations

1 site
  • Central laboratory in Fuda cancer hospital
    Guangzhou, Guangdong 510665, China
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References and documents

Publications

  • 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. PubMed 25217799 ↗
  • Yu N, Zhou J, Cui F, Tang X. Circulating tumor cells in lung cancer: detection methods and clinical applications. Lung. 2015 Apr;193(2):157-71. doi: 10.1007/s00408-015-9697-7. Epub 2015 Feb 19. PubMed 25690734 ↗
  • Han Y, Su C, Liu Z. Methods for detection of circulating cells in non-small cell lung cancer. Front Biosci (Landmark Ed). 2014 Jun 1;19(6):896-903. doi: 10.2741/4255. PubMed 24896324 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02412384
Lead sponsor
Fuda Cancer Hospital, Guangzhou
Responsible party
Sponsor
First posted
Apr 9, 2015
Start date
Jun 2013
Primary completion
Dec 2015
Completion
Feb 2016
Last update
Feb 25, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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