NCT03214991

Brief Summary

The aim of this study is to determine the usefulness of circulating tumor DNA as a prognostic factor in patients with 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 May 2017

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

May 12, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

3.4 years

First QC Date

July 11, 2017

Last Update Submit

February 1, 2018

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival rate

    Comparison of overall survival rates between patients with and without blood-circulating tumor DNA

    48 months

Secondary Outcomes (5)

  • Overall survival rate according to the amount of blood circulating tumor DNA

    48mo

  • K-ras mutation

    48 months

  • Overall survival rate (EUS-FNA)

    48 months

  • Overall survival rate (K-ras mutation type, circulating tumor DNA)

    48 months

  • Overall survival rate (K-ras mutation type, EUS-FNA)

    48 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with pancreatic cancer through EUS-FNA.

You may qualify if:

  • Patients diagnosed with pancreatic cancer through EUS-FNA.

You may not qualify if:

  • Severe mental illness
  • Severe co-morbidity (ESRD, Advanced COPD, severe Heart failure, poorly controlled blood sugar)
  • Pregnancy
  • Patients who have received chemotherapy
  • Coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood circulating tumor DNA in patients with pancreatic cancer

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Ji Kon Ryu, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Young Hoon Choi, MD

CONTACT

82-2-2072-2228crzyzs@naver.com

Ji Kon Ryu, MD, PhD

CONTACT

82-2-2072-2228jkryu@snu.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 11, 2017

First Posted

July 12, 2017

Study Start

May 12, 2017

Primary Completion

September 30, 2020

Study Completion

March 31, 2021

Last Updated

February 5, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)