NCT04281511

Brief Summary

  1. 1.Based on the literature, the pancreatic cancer treatment predictor biomarker, which is used in the domestic clinical field, is actually applied to the pancreatic cancer patient cohort of the National Cancer Center.
  2. 2.To systematically prospectively identify prospective treatment response biomarkers for Pancreatic Cancer Cohort in the National Cancer Center

Trial Health

87
On Track

Trial Health Score

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

Enrollment
238

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 3, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

4.5 years

First QC Date

February 20, 2020

Last Update Submit

November 9, 2023

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancerBiomarkerchemotherapypharmacogenomicclinical trials

Outcome Measures

Primary Outcomes (2)

  • median survival

    The length of time from either the date of diagnosis or the start of treatment for a disease,the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse

    5 years

  • progressive-free survival

    The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse

    5 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pancreatic Cancer Patients

You may qualify if:

  • Pathologically Confirmed Pancreatic Cancer Patients

You may not qualify if:

  • Subjects who do not agree with the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu,

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

Related Publications (5)

  • Farrell JJ, Elsaleh H, Garcia M, Lai R, Ammar A, Regine WF, Abrams R, Benson AB, Macdonald J, Cass CE, Dicker AP, Mackey JR. Human equilibrative nucleoside transporter 1 levels predict response to gemcitabine in patients with pancreatic cancer. Gastroenterology. 2009 Jan;136(1):187-95. doi: 10.1053/j.gastro.2008.09.067. Epub 2008 Oct 7.

    PMID: 18992248RESULT

  • Greenhalf W, Ghaneh P, Neoptolemos JP, Palmer DH, Cox TF, Lamb RF, Garner E, Campbell F, Mackey JR, Costello E, Moore MJ, Valle JW, McDonald AC, Carter R, Tebbutt NC, Goldstein D, Shannon J, Dervenis C, Glimelius B, Deakin M, Charnley RM, Lacaine F, Scarfe AG, Middleton MR, Anthoney A, Halloran CM, Mayerle J, Olah A, Jackson R, Rawcliffe CL, Scarpa A, Bassi C, Buchler MW; European Study Group for Pancreatic Cancer. Pancreatic cancer hENT1 expression and survival from gemcitabine in patients from the ESPAC-3 trial. J Natl Cancer Inst. 2014 Jan;106(1):djt347. doi: 10.1093/jnci/djt347. Epub 2013 Dec 3.

    PMID: 24301456RESULT

  • Yamada R, Mizuno S, Uchida K, Yoneda M, Kanayama K, Inoue H, Murata Y, Kuriyama N, Kishiwada M, Usui M, Ii N, Tsuboi J, Tano S, Hamada Y, Tanaka K, Horiki N, Ogura T, Shiraishi T, Takei Y, Katayama N, Isaji S. Human Equilibrative Nucleoside Transporter 1 Expression in Endoscopic Ultrasonography-Guided Fine-Needle Aspiration Biopsy Samples Is a Strong Predictor of Clinical Response and Survival in the Patients With Pancreatic Ductal Adenocarcinoma Undergoing Gemcitabine-Based Chemoradiotherapy. Pancreas. 2016 May-Jun;45(5):761-71. doi: 10.1097/MPA.0000000000000597.

    PMID: 26784908RESULT

  • Sebastiani V, Ricci F, Rubio-Viqueira B, Kulesza P, Yeo CJ, Hidalgo M, Klein A, Laheru D, Iacobuzio-Donahue CA. Immunohistochemical and genetic evaluation of deoxycytidine kinase in pancreatic cancer: relationship to molecular mechanisms of gemcitabine resistance and survival. Clin Cancer Res. 2006 Apr 15;12(8):2492-7. doi: 10.1158/1078-0432.CCR-05-2655.

    PMID: 16638857RESULT

  • Capello M, Lee M, Wang H, Babel I, Katz MH, Fleming JB, Maitra A, Wang H, Tian W, Taguchi A, Hanash SM. Carboxylesterase 2 as a Determinant of Response to Irinotecan and Neoadjuvant FOLFIRINOX Therapy in Pancreatic Ductal Adenocarcinoma. J Natl Cancer Inst. 2015 May 29;107(8):djv132. doi: 10.1093/jnci/djv132. Print 2015 Aug.

    PMID: 26025324RESULT

Biospecimen

Retention: SAMPLES WITH DNA

cancer tissue

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sangmyung Woo

    National Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Senior Scientist

Study Record Dates

First Submitted

February 20, 2020

First Posted

February 24, 2020

Study Start

April 3, 2019

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations

KR(1)