CClinicalTrials.gg
Status unknownNCT03665571Updated Sep 11, 2018

Evaluation of Killing Activity of Expanded Natural Killer Cells From Blood in Patients With Pancreatic Cancer

An observational study in Pancreatic Neoplasms, sponsored by Asan Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-11.

Sponsored by Asan Medical Center · Observational

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
20 Years to 80 Years
Sex
All
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Study summary

Pancreatic cancer, one of the deadliest epithelial malignancies, has a 5-year survival rate of only about 8%. The mortality rate has decreased slightly, but the incidence rate has been steadily increasing, and it is predicted to be the second leading cause of cancer mortality in 2030. Early diagnosis of pancreatic cancer and the development of innovative therapies are needed, and various basic and clinical studies based on pancreatic cancer biology are underway. Recently, studies on the effect of natural killer (NK) cells on cancer progression and the development of therapeutic agents using them have been actively conducted. NK cells are a component of innate lymphoid cells, accounting for approximately 5-15% of total peripheral blood mononuclear cells (PBMC).

Read the detailed description

Investigators will apply a new method to evaluate the activity of NK cells in pancreatic cancer patients, and to analyze the correlation with the progression of the tumor and the prognosis of the patient. And investigators will analyze the multifactorial factors affecting the activity of NK cells and conducted this study to help establish new diagnostic and therapeutic strategies for pancreatic cancer.

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Conditions studied

  • Pancreatic Neoplasms
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In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 620 observational studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Pancreatic ductal adenocarcinoma Mucinous adenocarcinoma Neuroendocrine carcinoma Adenosquamous carcinoma Mucinous cystic neoplasm Intraductal mucinous neoplasm Solid pseudopapillary neoplasm Neuroendocrine tumor Serous cystic neoplasm Benign cyst Chronic pancreatitis

Inclusion criteria

  • The patient who is admitted to the pancreatic surgery department for the treatment of pancreas tumor
  • Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.
  • Life expectancy of at least 6 months based on discretion of treating
  • Adequate hematologic function defined by the following laboratory parameters: Hemoglobin > 100, Platelet count > 100 and Absolute granulocyte count > 1.5.

Exclusion criteria

Exclusion Criteria:

  • Patients who received preoperative chemotherapy or radiotherapy.
  • Previous or concurrent malignancies.
  • Any serious medical condition within 6 months prior to study entry such as myocardial infarction, uncontrolled congestive heart failure, unstable angina, serous infection.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • Conventional Activation method

    NK cell was incubated with either K562 cells

    Diagnostic Test: Receptor specific activation method

  • Receptor specific activation method

    NK cell was incubated with P815-ULBP1+CD48 cells that trigger NK cell synergy via NKG2D and 2B4

    Diagnostic Test: Receptor specific activation method

Interventions

  • Diagnostic testReceptor specific activation method

    NK cell was incubated with P815-ULBP1+CD48 cells that trigger NK cell synergy via NKG2D and 2B4

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What researchers measure

Primary outcomes

  1. NK cell activity

    In order to compare the activity of NK cells according to the activation method, NK cells obtained from the blood of participants will be analyzed. Investigates will use two methods to analysis the activity of NK cell by FACS (Fluorescence-activated cell sorting). The degree of expression of CD107a on the cell surface and the degree of IFN-γ secretion will be compared by FACS.

    Time frame: 1 month before operation

Secondary outcomes

  1. Tumor recurrence

    In order to analyze the correlation of NK cell activity with the prognosis of the participants, investigators will follow up the recurrence of the tumor. This will be analyzed with the activity of NK cell.

    Time frame: two year after tumor diagnosis

  2. Survival of participants

    In order to analyze the correlation of NK cell activity with the prognosis of the participants, investigators will follow up the survival of the patients. This will be analyzed with the activity of NK cell.

    Time frame: two year after tumor diagnosis

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Study locations

1 of 1 sites recruiting
  • Asan Medical Center
    Seoul, Korea, Republic of
    • Eunsung Jun, MD., PhD. · Contact · go1040@hanmail.net · 82-2-3010-1696
    • Song-Cheol Kin Kim, MD, PhD. · Principal investigator
    • Eunsung Jun, MD., PhD. · Sub investigator
    • Hun Sik Kim, PhD · Sub investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03665571
Lead sponsor
Asan Medical Center
Responsible party
Song Cheol Kim (Professor, Asan Medical Center) — Principal investigator
First posted
Sep 11, 2018
Start date
Jul 2016
Primary completion
Oct 2018 (estimated)
Completion
Oct 2019 (estimated)
Last update
Sep 11, 2018

Study contacts

Eunsung Jun, MD
Contact
go1040@hanmail.net
2-3010-1696
Song Cheol Kim, MD
Contact
drksc@amc.seoul.kr
2-3010-3936
Song Cheol Kim, MD
principal investigator · Asan Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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