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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

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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Procedure: Blood collection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Actual Study Start Date : August 8, 2016
Actual Primary Completion Date : December 20, 2017
Actual Study Completion Date : December 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Patient Group
Pancreatic cancer patients
Procedure: Blood collection
1ml of blood specimen collection

Control Group
Healthy people without evidence of malignancy
Procedure: Blood collection
1ml of blood specimen collection




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Correlation of the cytotoxic immune status [ Time Frame: 24-hour after blood collection ]
    Correlation of the cytotoxic immune status with tumor markers



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Ages Eligible for Study:   19 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02887599


Locations
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Korea, Republic of
Severance Hospital, Yonsei University
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02887599     History of Changes
Other Study ID Numbers: 4-2016-0015
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases