Pancreas Cancer Detection Consortium (PCDC)
24. september 2026 opdateret af: City of Hope Medical Center
Tidlig påvisning af bugspytkirtelkræft: Prospektiv undersøgelse
This study aims to prospective validate an exosome-based miRNA signature for noninvasive and early detection of pancreatic ductal adenocarcinoma.
Studieoversigt
Status
Rekruttering
Betingelser
- Bugspytkirtel neoplasmer
- Kræft i bugspytkirtlen
- Adenocarcinom i bugspytkirtlen
- Duktalt adenokarcinom i bugspytkirtlen
- Kræft i bugspytkirtlen Resecerbar
- Pancreascarcinom
- Bugspytkirtelkræft Ikke-operabel
- Bugspytkirtelkræft fase III
- Bugspytkirtelkræftstadiet
- Bugspytkirtelkræft fase II
- Kræft i bugspytkirtlen, voksen
- Bugspytkirtelkræft fase I
- Bugspytkirtelkræft fase 0
Intervention / Behandling
Detaljeret beskrivelse
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 identifying PDAC at its earliest stages.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
2000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ajay Goel, PhD
- Telefonnummer: 6262183452
- E-mail: AJGOEL@COH.ORG
Studiesteder
-
-
Arizona
-
Phoenix, Arizona, Forenede Stater, 85004
- Rekruttering
- Translational Genomics Research Institute
-
Kontakt:
- Daniel Von Hoff
- E-mail: dvh@tgen.org
-
Ledende efterforsker:
- Daniel Von Hoff
-
Underforsker:
- Haiyong Han
-
Underforsker:
- Derek Cridebring
-
Scottsdale, Arizona, Forenede Stater, 85258
- Afsluttet
- Honorhealth
-
-
California
-
Monrovia, California, Forenede Stater, 91016
- Rekruttering
- City of Hope Medical Center
-
Underforsker:
- Alessandro Mannucci
-
Underforsker:
- Caiming Xu
-
Ledende efterforsker:
- Ajay Goel
-
Underforsker:
- Stanley Hamilton
-
Underforsker:
- Vincent Chung
-
Kontakt:
- Ajay Goel, PhD
- Telefonnummer: 626-218-3452
- E-mail: AJGOEL@COH.ORG
-
Newport Beach, California, Forenede Stater, 92663
- Afsluttet
- Hoag Center
-
-
Illinois
-
Peoria, Illinois, Forenede Stater, 61637
- Rekruttering
- OSF HealthCare
-
Kontakt:
- Chandler Wilfong
- E-mail: chandler.d.wilfong@osfhealthcare.org
-
Underforsker:
- Chandler Wilfong
-
-
Louisiana
-
Jefferson, Louisiana, Forenede Stater, 70121
- Rekruttering
- Ochsner Medical Center
-
Kontakt:
- John Bolton
- E-mail: jbolton@ochsner.org
-
Underforsker:
- John Bolton
-
-
New Jersey
-
Morristown, New Jersey, Forenede Stater, 07960
- Rekruttering
- Atlantic Health System
-
Kontakt:
- Angela Alistar
- E-mail: angela.alistar@atlantichealth.org
-
Underforsker:
- Angela Alistar
-
Underforsker:
- Eric Whitman
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Forenede Stater, 15212
- Rekruttering
- AHN Cancer Institute at Allegheny General Hospital
-
Kontakt:
- Ali Zaidi, MD
- E-mail: ali.zaidi@ahn.org
-
-
South Carolina
-
Rock Hill, South Carolina, Forenede Stater, 29732
- Rekruttering
- Piedmont Medical Center
-
Kontakt:
- Andrew Page
- E-mail: Andrew.Page@piedmont.org
-
Underforsker:
- Andrew Page
-
Underforsker:
- Eyal Meiri
-
-
Washington
-
Tacoma, Washington, Forenede Stater, 98405
- Rekruttering
- MultiCare Cancer Institute - Tacoma General Hospital
-
Kontakt:
- Alex Cantafio, MD
- E-mail: alex.cantafio@multicare.org
-
-
Wisconsin
-
Milwaukee, Wisconsin, Forenede Stater, 53226
- Rekruttering
- Medical College of Wisconsin
-
Kontakt:
- Douglas Evans
- E-mail: devans@mcw.edu
-
Underforsker:
- Douglas Evans
-
-
-
-
-
Nagoya, Japan
- Rekruttering
- Nagoya University
-
Underforsker:
- Yasuhiro Kodera
-
Kontakt:
- Yasuhiro Kodera
- E-mail: ykodera@med.nagoya-u.ac.jp
-
Underforsker:
- Masamichi Hayashi
-
-
-
-
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Seoul, Sydkorea
- Rekruttering
- Asan Medical Center
-
Kontakt:
- Song Cheol Kim
- E-mail: drksc@amc.seoul.kr
-
Underforsker:
- Song Cheol Kim
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Independent cohorts of individuals with and without pancreatic cancer (cases and controls, respectively)
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: CASE_CONTROL
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Patients with Pancreatic Cancer Ductal Adenocarcinoma (Training)
Individuals diagnosed with pancreatic ductal adenocarcinoma |
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
Andre navne:
|
|
Individuals without Pancreatic Cancer Ductal Adenocarcinoma (Training)
Individuals without pancreatic ductal adenocarcinoma |
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
Andre navne:
|
|
Patients with Pancreatic Cancer Ductal Adenocarcinoma (Validation)
Individuals diagnosed with pancreatic ductal adenocarcinoma |
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
Andre navne:
|
|
Individuals without Pancreatic Cancer Ductal Adenocarcinoma (Validation)
Individuals without pancreatic ductal adenocarcinoma |
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
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Sensitivity
Tidsramme: Through study completion, an average of 1 year
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Specificity
Tidsramme: Through study completion, an average of 1 year
|
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
|
|
Accuracy
Tidsramme: Through study completion, an average of 1 year
|
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Ajay Goel, PhD, City of Hope Medical Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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- Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.
- Crowley E, Di Nicolantonio F, Loupakis F, Bardelli A. Liquid biopsy: monitoring cancer-genetics in the blood. Nat Rev Clin Oncol. 2013 Aug;10(8):472-84. doi: 10.1038/nrclinonc.2013.110. Epub 2013 Jul 9.
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- Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Pantel K, Alix-Panabieres C. Liquid biopsy and minimal residual disease - latest advances and implications for cure. Nat Rev Clin Oncol. 2019 Jul;16(7):409-424. doi: 10.1038/s41571-019-0187-3.
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- Fahrmann JF, Schmidt CM, Mao X, Irajizad E, Loftus M, Zhang J, Patel N, Vykoukal J, Dennison JB, Long JP, Do KA, Zhang J, Chabot JA, Kluger MD, Kastrinos F, Brais L, Babic A, Jajoo K, Lee LS, Clancy TE, Ng K, Bullock A, Genkinger J, Yip-Schneider MT, Maitra A, Wolpin BM, Hanash S. Lead-Time Trajectory of CA19-9 as an Anchor Marker for Pancreatic Cancer Early Detection. Gastroenterology. 2021 Mar;160(4):1373-1383.e6. doi: 10.1053/j.gastro.2020.11.052. Epub 2020 Dec 14.
- 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.
- Gui JC, Yan WL, Liu XD. CA19-9 and CA242 as tumor markers for the diagnosis of pancreatic cancer: a meta-analysis. Clin Exp Med. 2014 May;14(2):225-33. doi: 10.1007/s10238-013-0234-9. Epub 2013 Mar 3.
- Tempero MA, Uchida E, Takasaki H, Burnett DA, Steplewski Z, Pour PM. Relationship of carbohydrate antigen 19-9 and Lewis antigens in pancreatic cancer. Cancer Res. 1987 Oct 15;47(20):5501-3.
- 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.
- Luo G, Liu C, Guo M, Cheng H, Lu Y, Jin K, Liu L, Long J, Xu J, Lu R, Ni Q, Yu X. Potential Biomarkers in Lewis Negative Patients With Pancreatic Cancer. Ann Surg. 2017 Apr;265(4):800-805. doi: 10.1097/SLA.0000000000001741.
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- Shigeyasu K, Toden S, Zumwalt TJ, Okugawa Y, Goel A. Emerging Role of MicroRNAs as Liquid Biopsy Biomarkers in Gastrointestinal Cancers. Clin Cancer Res. 2017 May 15;23(10):2391-2399. doi: 10.1158/1078-0432.CCR-16-1676. Epub 2017 Jan 31.
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. marts 2023
Primær færdiggørelse (Anslået)
30. december 2030
Studieafslutning (Anslået)
30. december 2030
Datoer for studieregistrering
Først indsendt
19. april 2024
Først indsendt, der opfyldte QC-kriterier
24. april 2024
Først opslået (Faktiske)
29. april 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 19288/PCDC
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
IPD-planbeskrivelse
Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data
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