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

• Conditions: Pancreatic Cancer

• Registration Number: NCT02934984
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-10-13
• Study First Posted: 2016-10-17
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17
• Primary Completion: 2020-07
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rates of recurrence in pancreatic cancer patients	36 months

Secondary Outcome Measures

Name	Time	Method
Rates of death in pancreatic cancer patients	36 months

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of