NCT02934984

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

4 years

First QC Date

October 13, 2016

Last Update Submit

April 15, 2019

Conditions

Pancreatic Cancer

Keywords

Pancreatic CancerrecurrenceDNA

Outcome Measures

Primary Outcomes (1)

  • Rates of recurrence in pancreatic cancer patients

    36 months

Secondary Outcomes (1)

  • Rates of death in pancreatic cancer patients

    36 months

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

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.

MeSH Terms

Conditions

Pancreatic NeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Joo Kyung Park, MD

CONTACT

82-2-3410-3409mdsophie@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

October 13, 2016

First Posted

October 17, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2020

Study Completion

January 1, 2021

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

KR(1)