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CompletedNCT04281511Updated Nov 13, 2023

A Longitudinal, Observational Biomarker Study in Pancreatic Cancer Patients Receiving Chemotherapy

An observational study in Pancreatic Cancer, sponsored by National Cancer Center, Korea. Completed at 1 site in South Korea. Per ClinicalTrials.gov, last updated 2023-11-13.

Sponsored by National Cancer Center, Korea · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
238
Sex
All
01

Study summary

  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. To systematically prospectively identify prospective treatment response biomarkers for Pancreatic Cancer Cohort in the National Cancer Center
Read the detailed description
  1. Immunohistochemistry and gene test for hENT1, DCK, SMAD4, CES2, BRCA 1/2,PALB2, MMRd, MSI, Tumor Ag and etc. on Cancer sample
  2. Collect data of Biomarker for pancreatic cancer
  3. Compare with Big data and Cohort study in National cancer center
  4. The number of subjects is changed by statistical consideration. 218->238
02

Conditions studied

  • Pancreatic Cancer

Keywords

  • Pancreatic cancer
  • Biomarker
  • chemotherapy
  • pharmacogenomic
  • clinical trials
03

In context

Pancreatic Neoplasms

3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.

This study's enrollment of 238 is above the median of 200 across 636 observational studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

National Cancer Center, Korea is the lead sponsor of 203 studies on the registry; 36 are open to participants now.

Browse National Cancer Center, Korea studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pancreatic Cancer Patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pathologically Confirmed Pancreatic Cancer Patients

Exclusion criteria

Exclusion Criteria:

  • Subjects who do not agree with the study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
238 participants (actual)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 5 years

  2. 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

    Time frame: 5 years

07

Study locations

1 site
  • NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu,
    Goyang-si, Gyeonggi-do 10408, South Korea
08

References and documents

Publications

  • 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. PubMed 18992248 ↗
  • 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. PubMed 24301456 ↗
  • 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. PubMed 26784908 ↗
  • 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. PubMed 16638857 ↗
  • 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. PubMed 26025324 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2019 to primary completion in Sep 2023, 53 months.

Of 276 non-industry observational studies under Pancreatic Neoplasms, half reached primary completion within 86 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 206. This study's 53 months is below that.

Counting every sponsor, half of 305 studies reached it within 83 months; a quarter within 40 and three quarters within 206.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 20, 2020
First posted
Feb 24, 2020
StartActual
Apr 3, 2019
Primary completionActual
Sep 30, 2023
CompletionActual
Sep 30, 2023
Last update
Nov 13, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04281511
Lead sponsor
National Cancer Center, Korea
Responsible party
Sang Myung Woo (Chief, Senior Scientist, National Cancer Center, Korea) — Principal investigator
First posted
Feb 24, 2020
Start date
Apr 3, 2019
Primary completion
Sep 30, 2023
Completion
Sep 30, 2023
Last update
Nov 13, 2023

Study contacts

Sangmyung Woo
principal investigator · National Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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