ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02450422
Recruitment Status : Completed
First Posted : May 21, 2015
Last Update Posted : December 30, 2015
Sponsor:
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

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 colorectal 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 colorectal 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.

Condition or disease Intervention/treatment
Neoplastic Cells, Circulating Other: Flow cytometry (FCM) Other: RT-PCR

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 colorectal 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
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Detection of Circulating Tumor Cells (CTCs) in Patients With Colorectal Cancer Undergoing Cryosurgery Combined With DC-CIK Treatment
Study Start Date : June 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Control
Use Flow cytometry (FCM) and RT-PCR to test peripheral blood mononuclear cells(PBMCs) from healthy volunteer.
Other: Flow cytometry (FCM)
Use FCM to test PBMCs/CTCs from volunteers/patients.

Other: RT-PCR
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.
Other: Flow cytometry (FCM)
Use FCM to test PBMCs/CTCs from volunteers/patients.

Other: RT-PCR
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.
Other: Flow cytometry (FCM)
Use FCM to test PBMCs/CTCs from volunteers/patients.

Other: RT-PCR
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.
Other: Flow cytometry (FCM)
Use FCM to test PBMCs/CTCs from volunteers/patients.

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




Primary Outcome Measures :
  1. The number of Circulating Tumor Cells (CTCs) [ Time Frame: Up to 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with Ⅱ,Ⅲ,Ⅳ stage colorectal cancer come to Fuda Hospital for treatment.
Criteria

Inclusion Criteria:

  1. Age:18-75
  2. Karnofsky performance status >60
  3. Diagnosis of colorectal 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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02450422


Locations
China, Guangdong
Central laboratory in Fuda cancer hospital
Guangzhou, Guangdong, China, 510665
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou

Publications:
Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT02450422     History of Changes
Other Study ID Numbers: Colorectal Cancer CTC 001
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: December 30, 2015
Last Verified: December 2015

Keywords provided by Fuda Cancer Hospital, Guangzhou:
Colorectal Neoplasms
Circulating Tumor Cells

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplastic Cells, Circulating
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes