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Assessment of the Cytotoxic Immune Status of Pancreatic Cancer Patients and the Severity of the Cancer Using Measurement of Natural Killer Cell Activities

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ClinicalTrials.gov Identifier: NCT02887599
Recruitment Status : Completed
First Posted : September 2, 2016
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date  ICMJE August 22, 2016
First Posted Date  ICMJE September 2, 2016
Last Update Posted Date January 16, 2019
Actual Study Start Date  ICMJE August 8, 2016
Actual Primary Completion Date December 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2016)
  • Difference of the cytotoxic immune status [ Time Frame: 24-hour after blood collection ]
    Difference of the cytotoxic immune status between patients group and control group by comparing quantitative measurements of NK cell activities by ELISA kit
  • Difference of the severity of the pancreatic cancer [ Time Frame: 24-hour after blood collection ]
    Difference of the cytotoxic immune status according to the stage of the pancreatic cancer by comparing quantitative measurements of NK cell activities by ELISA kit
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02887599 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2016)
Correlation of the cytotoxic immune status [ Time Frame: 24-hour after blood collection ]
Correlation of the cytotoxic immune status with tumor markers
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the Cytotoxic Immune Status of Pancreatic Cancer Patients and the Severity of the Cancer Using Measurement of Natural Killer Cell Activities
Official Title  ICMJE Not Provided
Brief Summary

Pancreatic cancer is the 5th leading cause of cancer death and the worst prognostic cancer in the world. This is due to high recurrent rate after surgical resection and poor response to chemotherapy and radiotherapy.

Recent studies revealed that peri-tumoral structure and patients' immune status including cytotoxic immunity played significant role in the bad behavior of pancreatic cancer. While past studies focused on oncogenes and tumor suppressor genes, recent studies focused on patients' own immunity. Patients' immunity modified by cancer cells is found to be correlated to cancer progression and metastasis.

Natural killer cells, playing an important role in cytotoxic immune system, are revealed to be decreased in patients with lung cancer, ovarian cancer, prostate cancer, colorectal cancer, and breast cancer. And in melanoma mouse model, when NK cell was suppressed, cancer progression and metastasis were accelerated.

This study sought to find the correlation of patients' cytotoxic immune status to cancer progression and status by measurement of NK cell activity in pancreatic cancer patients. This would be basic support to construct a prognostic model of pancreatic cancer for early metastasis and post operational recurrence.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE Procedure: Blood collection
1ml of blood specimen collection
Study Arms  ICMJE
  • Patient Group
    Pancreatic cancer patients
    Intervention: Procedure: Blood collection
  • Control Group
    Healthy people without evidence of malignancy
    Intervention: Procedure: Blood collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2019)
203
Original Estimated Enrollment  ICMJE
 (submitted: August 29, 2016)
200
Actual Study Completion Date  ICMJE December 20, 2017
Actual Primary Completion Date December 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age over 18 and under 85
  • Control group : incidental found benign pancreatic cyst, non-neoplastic gall bladder polyp (ex, cholesterol polyp), healthy people having no evidence of malignancy in check up within 1 year
  • Patient group : histological diagnosed pancreatic cancer patients, clinically diagnosed pancreatic cancer patients by radiologic evaluation
  • Agreed to enroll the study and signed informed consent

Exclusion Criteria:

  • Patients with other malignancies within 5 years
  • Patients treated with steroid due to any reason within 1 year
  • Not signed informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02887599
Other Study ID Numbers  ICMJE 4-2016-0015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP