Clinical trial NCT04281511: A Longitudinal, Observational Biomarker Study in Pancreatic Cancer Patients Receiving Chemotherapy
Official title: A Longitudinal, Observational Biomarker Study in Pancreatic Cancer Patients Receiving Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Keywords: Pancreatic cancer
Biomarker
chemotherapy
pharmacogenomic
clinical trials
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2020-02-24
Enrollment: 238
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pancreatic Cancer Patients

Brief 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

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

Eligibility criteria: Inclusion Criteria:

* Pathologically Confirmed Pancreatic Cancer Patients

Exclusion Criteria:

* Subjects who do not agree with the study

Primary outcomes:
measure: median survival
timeFrame: 5 years
measure: progressive-free survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu,
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center
name: Sangmyung Woo
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.