Pancreatic CancerNCT04281511
A Longitudinal, Observational Biomarker Study in Pancreatic Cancer Patients Receiving Chemotherapy
An observational study of Pancreatic Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 238 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Apr 2019to 30 Sep 2023
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pancreatic Cancer Patients
Who may be able to join
- Pathologically Confirmed Pancreatic Cancer Patients
Who cannot join
- Subjects who do not agree with the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu,
Goyang-si, Gyeonggi-do, 10408
About this study
- 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.
- To systematically prospectively identify prospective treatment response biomarkers for Pancreatic Cancer Cohort in the National Cancer Center
Read the detailed description
- Immunohistochemistry and gene test for hENT1, DCK, SMAD4, CES2, BRCA 1/2,PALB2, MMRd, MSI, Tumor Ag and etc. on Cancer sample
- Collect data of Biomarker for pancreatic cancer
- Compare with Big data and Cohort study in National cancer center
- The number of subjects is changed by statistical consideration. 218->238
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic cancer, Biomarker, chemotherapy, pharmacogenomic, clinical trials
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start3 Apr 2019
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 238 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sang Myung Woo, National Cancer Center, Korea
- Investigators
- Sangmyung Woo, Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281511
- Sponsor's protocol ID
- NCC2019-0034
- Status last verified
- Nov 2023
- First submitted
- 20 Feb 2020
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 18992248Greenhalf 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 24301456Yamada 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 26784908Sebastiani 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 16638857Capello 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal, Observational Biomarker Study in Pancreatic Cancer Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT04281511
- Acronym / sponsor ID
- NCC2019-0034
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic cancer, Biomarker, chemotherapy, pharmacogenomic, clinical trials
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- To systematically prospectively identify prospective treatment response biomarkers for Pancreatic Cancer Cohort in the National Cancer Center
Detailed description
- Immunohistochemistry and gene test for hENT1, DCK, SMAD4, CES2, BRCA 1/2,PALB2, MMRd, MSI, Tumor Ag and etc. on Cancer sample
- Collect data of Biomarker for pancreatic cancer
- Compare with Big data and Cohort study in National cancer center
- The number of subjects is changed by statistical consideration. 218->238
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pancreatic Cancer Patients
Key inclusion criteria (1 listed)
- Pathologically Confirmed Pancreatic Cancer Patients
Key exclusion criteria (1 listed)
- Subjects who do not agree with the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
median survival
Time frame: 5 years
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
progressive-free survival
Time frame: 5 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Results publication: PubMed 18992248Farrell 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.
- Results publication: PubMed 24301456Greenhalf 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.
- Results publication: PubMed 26784908Yamada 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.
- Results publication: PubMed 16638857Sebastiani 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.
- Results publication: PubMed 26025324Capello 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sangmyung Woo principal investigator
National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
median survival (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04281511, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.