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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06388967
Other study ID # 19288/PCDC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 15, 2023
Est. completion date November 21, 2025

Study information

Verified date April 2024
Source City of Hope Medical Center
Contact Ajay Goel, PhD
Phone 6262183452
Email AJGOEL@COH.ORG
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to prospective validate an exosome-based miRNA signature for noninvasive and early detection of pancreatic ductal adenocarcinoma.


Description:

Pancreatic ductal adenocarcinoma (PDAC) is one of the deadliest forms of cancer. It often goes undetected until it is at an advanced stage, making it challenging to treat. Currently, only a small percentage of patients are diagnosed early enough for effective treatment. While a blood marker exists, called serum carbohydrate antigen 19-9 (CA19-9), it is used primarily to track the disease and it is unreliable for early detection. To address this problem, the researchers have developed a new method to analyze circulating vesicles (called exosomes), which contain specific genetic material called microRNAs (miRNAs). In a previous study, by analyzing both the miRNAs that circulate freely in serum and the miRNAs that are inside the exosomes, the researchers have already identified a combination of 13 miRNAs that could accurately detect early-stage PDAC. In this study, the researchers will test this method in a larger international cohort study. This study aims to confirm the effectiveness of this approach in accurately identifying PDAC at its earliest stages.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date November 21, 2025
Est. primary completion date November 21, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histological diagnosis of pancreatic ductal adenocarcinoma, stages I-IV (TNM classification, 8th edition) - Received standard diagnostic and staging procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment. - Imaging- or endoscopy-based proof of lack of pancreatic ductal adenocarcinoma at the time of sampling (Non-disease controls) Exclusion Criteria: - Lack of written informed consent.

Study Design


Intervention

Diagnostic Test:
PANcreatic cancer Exosome Early detectiON (PANXEON)
This test will utilize quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) to quantify the expression levels of 5 cell-free and 8 exosome-miRNAs in plasma samples obtained from patients with pancreatic ductal adenocarcinoma and from individuals without it

Locations

Country Name City State
Japan Nagoya University Nagoya
Korea, Republic of Asan Medical Center Seoul
United States Ochsner Medical Center Jefferson Louisiana
United States Medical College of Wisconsin Milwaukee Wisconsin
United States City of Hope Medical Center Monrovia California
United States Atlantic Health System Morristown New Jersey
United States Hoag Center Newport Beach California
United States OSF HealthCare Peoria Illinois
United States Translational Genomics Research Institute Phoenix Arizona
United States Piedmont Medical Center Rock Hill South Carolina
United States Honorhealth Scottsdale Arizona

Sponsors (1)

Lead Sponsor Collaborator
City of Hope Medical Center

Countries where clinical trial is conducted

United States,  Japan,  Korea, Republic of, 

References & Publications (31)

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Jin X, Chen Y, Chen H, Fei S, Chen D, Cai X, Liu L, Lin B, Su H, Zhao L, Su M, Pan H, Shen L, Xie D, Xie C. Evaluation of Tumor-Derived Exosomal miRNA as Potential Diagnostic Biomarkers for Early-Stage Non-Small Cell Lung Cancer Using Next-Generation Sequencing. Clin Cancer Res. 2017 Sep 1;23(17):5311-5319. doi: 10.1158/1078-0432.CCR-17-0577. Epub 2017 Jun 12. — View Citation

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Majumder S, Taylor WR, Foote PH, Berger CK, Wu CW, Mahoney DW, Bamlet WR, Burger KN, Postier N, de la Fuente J, Doering KA, Lidgard GP, Allawi HT, Petersen GM, Chari ST, Ahlquist DA, Kisiel JB. High Detection Rates of Pancreatic Cancer Across Stages by Plasma Assay of Novel Methylated DNA Markers and CA19-9. Clin Cancer Res. 2021 May 1;27(9):2523-2532. doi: 10.1158/1078-0432.CCR-20-0235. Epub 2021 Feb 16. — View Citation

Martin LK, Wei L, Trolli E, Bekaii-Saab T. Elevated baseline CA19-9 levels correlate with adverse prognosis in patients with early- or advanced-stage pancreas cancer. Med Oncol. 2012 Dec;29(5):3101-7. doi: 10.1007/s12032-012-0278-9. Epub 2012 Jun 24. — View Citation

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Nakamura K, Zhu Z, Roy S, Jun E, Han H, Munoz RM, Nishiwada S, Sharma G, Cridebring D, Zenhausern F, Kim S, Roe DJ, Darabi S, Han IW, Evans DB, Yamada S, Demeure MJ, Becerra C, Celinski SA, Borazanci E, Tsai S, Kodera Y, Park JO, Bolton JS, Wang X, Kim SC — View Citation

Nishiwada S, Cui Y, Sho M, Jun E, Akahori T, Nakamura K, Sonohara F, Yamada S, Fujii T, Han IW, Tsai S, Kodera Y, Park JO, Von Hoff D, Kim SC, Li W, Goel A. Transcriptomic Profiling Identifies an Exosomal microRNA Signature for Predicting Recurrence Follo — View Citation

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Toiyama Y, Okugawa Y, Fleshman J, Richard Boland C, Goel A. MicroRNAs as potential liquid biopsy biomarkers in colorectal cancer: A systematic review. Biochim Biophys Acta Rev Cancer. 2018 Dec;1870(2):274-282. doi: 10.1016/j.bbcan.2018.05.006. Epub 2018 M — View Citation

Uesaka K, Boku N, Fukutomi A, Okamura Y, Konishi M, Matsumoto I, Kaneoka Y, Shimizu Y, Nakamori S, Sakamoto H, Morinaga S, Kainuma O, Imai K, Sata N, Hishinuma S, Ojima H, Yamaguchi R, Hirano S, Sudo T, Ohashi Y; JASPAC 01 Study Group. Adjuvant chemotherapy of S-1 versus gemcitabine for resected pancreatic cancer: a phase 3, open-label, randomised, non-inferiority trial (JASPAC 01). Lancet. 2016 Jul 16;388(10041):248-57. doi: 10.1016/S0140-6736(16)30583-9. Epub 2016 Jun 2. — View Citation

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* Note: There are 31 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity True positive rate: the probability of a positive test result, conditioned on the individual truly being positive Through study completion, an average of 1 year
Secondary Specificity True negative rate: the probability of a negative test result, conditioned on the individual truly being negative Through study completion, an average of 1 year
Secondary Accuracy A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined Through study completion, an average of 1 year
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