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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


2016-08-08


2017-12-20


2017-12-20


203

Study Overview

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

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.

N/A

  • Pancreatic Cancer
  • PROCEDURE: Blood collection
  • 4-2016-0015

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2016-08-22  

N/A  

2019-01-14  

2016-08-29  

N/A  

2019-01-16  

2016-09-02  

N/A  

2019-01  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic


Allocation:
Non Randomized


Interventional Model:
Parallel


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
OTHER: Patient Group

Pancreatic cancer patients

PROCEDURE: Blood collection

  • 1ml of blood specimen collection
OTHER: Control Group

Healthy people without evidence of malignancy

PROCEDURE: Blood collection

  • 1ml of blood specimen collection
Primary Outcome MeasuresMeasure DescriptionTime Frame
Difference of the cytotoxic immune statusDifference of the cytotoxic immune status between patients group and control group by comparing quantitative measurements of NK cell activities by ELISA kit24-hour after blood collection
Difference of the severity of the pancreatic cancerDifference of the cytotoxic immune status according to the stage of the pancreatic cancer by comparing quantitative measurements of NK cell activities by ELISA kit24-hour after blood collection
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Correlation of the cytotoxic immune statusCorrelation of the cytotoxic immune status with tumor markers24-hour after blood collection

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:
1

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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General Publications

No publications available