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Circulating Cell-free Tumor DNA(ctDNA) in Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02934984
Recruitment Status : Recruiting
First Posted : October 17, 2016
Last Update Posted : April 17, 2019
Information provided by (Responsible Party):
JooKyung Park, Samsung Medical Center

Brief Summary:
The aim of the study is to evaluate whether peripheral circulating cell-free tumor DNA(ctDNA) can help early screening of pancreatic cancer recurrence or not. And we are also planning to evaluate correlation between ctDNA with clinical outcome of pancreatic cancer.

Condition or disease
Pancreatic Cancer

Detailed Description:

In the formation and growth of a primary tumor, cells can released into the bloodstream. There are many researches for these circulating tumor cells(CTC) And recently circulating cell-free tumor DNA(ctDNA) released from apoptotic or necrotic tumor cells has developed. At one report which checked ctDNA level after operation of colon cancer patients, they suggested that ctDNA could show recurrence of cancer several months earlier than the conventional follow up imaging. And several reports suggested that ctDNA can invade host cell and change host cell biology, which can evoke cancer metastasis.

So in this study, the investigator will collect ctDNA of pancreatic cancer patients, benign pancreatic disease patients, and healthy population. And the investigator will evaluate whether peripheral ctDNA can help early screening of cancer recurrence. And we will study about genomic signature of ctDNA to evaluate relationship between ctDNA and clinical outcome of cancer patients.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Factors Related to Pancreatic Cancer Recurrence Using Circulating Cell-free Tumor DNA(ctDNA)
Study Start Date : July 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Rates of recurrence in pancreatic cancer patients [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Rates of death in pancreatic cancer patients [ Time Frame: 36 months ]

Biospecimen Retention:   Samples With DNA
The investigator will collect peripheral blood cell-free tumor DNA(ctDNA) in pancreatic cancer patients, benign pancreas disease patients and healthy population.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Consecutive pancreatic cancer patients who received EUS-FNA for diangosis and undergo operation, benign pancreas disease patients who received EUS-FNA for diagnosis, healthy population

Inclusion Criteria:

  • Comparative group : Pancreatic cancer patients who progress endoscopic ultrasonography fine-needle aspiration (EUS-FNA) for pancreatic cancer diagnosis, pancreatic cancer patients who are in operable stage
  • Control group : Benign pancreas disease patients who progress EUS-FNA for diagnosis, healthy population

Exclusion Criteria:

  • Foreigners
  • Pancreatic cancer patients who have other cancer
  • Patients who impossible to consent to study by own

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 identifier (NCT number): NCT02934984

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Contact: Joo Kyung Park, MD 82-2-3410-3409

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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Joo Kyung Park, MD    82-2-3410-3409   
Sponsors and Collaborators
Samsung Medical Center
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Responsible Party: JooKyung Park, Clinical assistant professor, Samsung Medical Center Identifier: NCT02934984    
Other Study ID Numbers: 2016-07-054
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by JooKyung Park, Samsung Medical Center:
Pancreatic Cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases