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Trial record 10 of 130 for:    Pancreatic Cancer | ( Map: South Korea )

Circulating Tumor DNA as a Prognostic Marker in Patients With Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03214991
Recruitment Status : Recruiting
First Posted : July 12, 2017
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Ji Kon Ryu, Seoul National University Hospital

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.

Condition or disease
Pancreatic Cancer

Detailed Description:
There is currently no strong prognostic factor in pancreatic cancer. K-ras is the most commonly mutated gene in pancreatic cancer, with a mutation rate of 75% to 95%. These high mutation rates are expected to be useful for diagnosis and prognostic factors in future. Currently, K-ras mutation tests are often performed in tissues, and there are various limitations, in particular, limited obtaining of sufficient tissues. In this regard, analyzing the prognosis of pancreatic cancer through non-invasive blood testing has significant advantages. And Prognosis analysis through blood tests can be done through blood circulating tumor DNA. The relationship between prognosis and blood circulating tumor DNA has already been studied in other cancers such as colorectal cancer, and there have been several studies in pancreatic cancer. However, there are not many research results yet, and there are cases in which the results differ from study to study. Therefore, the purpose of this study is to compare the overall survival of patients with pancreatic cancer diagnosed by EUS-FNA according to the presence and amount of blood circulating tumor DNA with K-ras mutation.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Circulating Tumor DNA as a Prognostic Marker in Patients With Pancreatic Cancer
Actual Study Start Date : May 12, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Overall survival rate [ Time Frame: 48 months ]
    Comparison of overall survival rates between patients with and without blood-circulating tumor DNA


Secondary Outcome Measures :
  1. Overall survival rate according to the amount of blood circulating tumor DNA [ Time Frame: 48mo ]
    Overall survival rate according to the amount of blood circulating tumor DNA

  2. K-ras mutation [ Time Frame: 48 months ]
    The concordance rate of K-ras mutation in EUS-FNA specimen and K-ras mutation in blood circulating tumor DNA

  3. Overall survival rate (EUS-FNA) [ Time Frame: 48 months ]
    Overall survival rate with or without K-ras mutation of EUS-FNA specimen

  4. Overall survival rate (K-ras mutation type, circulating tumor DNA) [ Time Frame: 48 months ]
    Overall survival rate according to K-ras mutation type in blood circulating tumor DNA

  5. Overall survival rate (K-ras mutation type, EUS-FNA) [ Time Frame: 48 months ]
    Overall survival rate according to K-ras mutation type in EUS-FNA specimen


Biospecimen Retention:   Samples With DNA
peripheral blood circulating tumor DNA in patients with pancreatic cancer


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients diagnosed with pancreatic cancer through EUS-FNA.
Criteria

Inclusion Criteria:

  • Patients diagnosed with pancreatic cancer through EUS-FNA.

Exclusion Criteria:

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

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 ClinicalTrials.gov identifier (NCT number): NCT03214991


Contacts
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Contact: Young Hoon Choi, MD 82-2-2072-2228 crzyzs@naver.com
Contact: Ji Kon Ryu, MD, PhD 82-2-2072-2228 jkryu@snu.ac.kr

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Jongno-gu, Korea, Republic of, 03080
Contact: Young Hoon Choi, MD    82-2-2072-2228    crzyzs@naver.com   
Sponsors and Collaborators
Ji Kon Ryu
Investigators
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Principal Investigator: Ji Kon Ryu, MD, PhD Seoul National University Hospital

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Responsible Party: Ji Kon Ryu, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03214991     History of Changes
Other Study ID Numbers: 1704-108-847
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases