Back to results

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

Primary Purpose

Pancreatic Cancer

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Blood collection

About this trial

This is an interventional diagnostic trial for Pancreatic Cancer

Eligibility Criteria

19 Years - 84 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Severance Hospital, Yonsei University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Patient Group

Control Group

Arm Description

Pancreatic cancer patients

Healthy people without evidence of malignancy

Outcomes

Primary Outcome Measures

Difference of the cytotoxic immune status

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

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

Correlation of the cytotoxic immune status

Correlation of the cytotoxic immune status with tumor markers

Full Information

NCT ID

NCT02887599

First Posted

August 22, 2016

Last Updated

January 14, 2019

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02887599

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

August 8, 2016 (Actual)

Primary Completion Date

December 20, 2017 (Actual)

Study Completion Date

December 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

203 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patient Group

Arm Type

Other

Arm Description

Pancreatic cancer patients

Arm Title

Control Group

Arm Type

Other

Arm Description

Healthy people without evidence of malignancy

Intervention Type

Procedure

Intervention Name(s)

Blood collection

Intervention Description

1ml of blood specimen collection

Primary Outcome Measure Information:

Title

Difference of the cytotoxic immune status

Description

Difference of the cytotoxic immune status between patients group and control group by comparing quantitative measurements of NK cell activities by ELISA kit

Time Frame

24-hour after blood collection

Title

Difference of the severity of the pancreatic cancer

Description

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

Time Frame

24-hour after blood collection

Secondary Outcome Measure Information:

Title

Correlation of the cytotoxic immune status

Description

Correlation of the cytotoxic immune status with tumor markers

Time Frame

24-hour after blood collection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

84 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Severance Hospital, Yonsei University

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs