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

NCT ID: NCT04281511

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

238 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-03

Study Completion Date

2023-09-30

Brief Summary

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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

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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

Conditions

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Pancreatic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Pathologically Confirmed Pancreatic Cancer Patients

Exclusion Criteria

* Subjects who do not agree with the study
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sang Myung Woo

Chief, Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sangmyung Woo

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center

Locations

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

Goyang-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type RESULT
PMID: 18992248 (View on PubMed)

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.

Reference Type RESULT
PMID: 24301456 (View on PubMed)

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.

Reference Type RESULT
PMID: 26784908 (View on PubMed)

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.

Reference Type RESULT
PMID: 16638857 (View on PubMed)

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.

Reference Type RESULT
PMID: 26025324 (View on PubMed)

Other Identifiers

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NCC2019-0034

Identifier Type: -

Identifier Source: org_study_id

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