Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Pancreatic Cancer Screening Using the Enzeavour Assay in Japan (ENZEAVOUR FS)

23 juni 2026 uppdaterad av: Cosomil, Inc.

Pancreatic Cancer Screening Using Single-Molecule Enzyme Activity-Based Liquid Biopsy, Enzeavour: A Single-Arm Interventional Feasibility Study Protocol in Japan

This nationwide, multicenter, prospective, single-arm interventional feasibility study evaluates the Enzeavour Pancreatic Cancer assay in routine health checkups and cancer screening in Japan. Approximately 10,000 asymptomatic adults will be enrolled. Participants with an Enzeavour Score above 0.369 will undergo diagnostic work-up as clinically indicated. The primary outcome is pancreatic cancer detection rate within 12 months after the index blood draw, and the secondary outcome is positive predictive value.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Pancreatic cancer is often diagnosed at an advanced stage, and an effective population-based screening strategy has not been established. The Enzeavour Pancreatic Cancer assay is a blood-based test that quantifies the activity of three specific enzymes at a single-molecule level and integrates four biomarkers into a composite Enzeavour Score.

This nationwide, multicenter, prospective, single-arm feasibility study evaluates the Enzeavour assay in routine health checkups and cancer screening in Japan. Approximately 10,000 asymptomatic adults will be enrolled. Participants with an Enzeavour Score greater than 0.369 will be referred for diagnostic work-up as clinically indicated. This study uses a partial verification design with 12-month follow-up for pre-specified subgroups and aims to generate real-world estimates of pancreatic cancer detection rate and positive predictive value for future trial planning.

Studietyp

Interventionell

Inskrivning (Beräknad)

10000

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Japan
    • Aichi-ken
      • Nagakute, Aichi-ken, Japan
        • Rekrytering
        • Aichi Medical University Hospital
      • Nagoya, Aichi-ken, Japan
        • Rekrytering
        • Nagoya University Hospital
    • Hiroshima
      • Hiroshima, Hiroshima, Japan
        • Rekrytering
        • Hiroshima University Hospital
      • Onomichi, Hiroshima, Japan
        • Rekrytering
        • JA Onomichi General Hospital
        • Kontakt:
          • Keiji Hanada, MD, Ph.D.
        • Huvudutredare:
          • Keiji Hanada, MD, Ph.D.
    • Hokkaido
      • Obihiro, Hokkaido, Japan
        • Rekrytering
        • Obihiro Kosei Hospital
      • Sapporo, Hokkaido, Japan
        • Rekrytering
        • Keijinkai Maruyama Clinic
      • Sapporo, Hokkaido, Japan
        • Rekrytering
        • Teine Keijinkai Hospital
    • Hyōgo
      • Kobe, Hyōgo, Japan
        • Rekrytering
        • Hotel Okura Kobe Clinic
      • Kobe, Hyōgo, Japan
        • Rekrytering
        • Kobe University Hospital
    • Ibaraki
      • Mito, Ibaraki, Japan
        • Rekrytering
        • Ibaraki Medical Center
      • Mito, Ibaraki, Japan
        • Rekrytering
        • Mito Kyodo General Hospital
    • Kagawa-ken
      • Kita-gun Miki-cho, Kagawa-ken, Japan
        • Rekrytering
        • Kagawa University Hospital
    • Kanagawa
      • Atsugi, Kanagawa, Japan
        • Rekrytering
        • JA Health Management Center Atsugi
      • Isehara, Kanagawa, Japan
        • Rekrytering
        • Isehara Kyodo Hospital
      • Kawasaki, Kanagawa, Japan
        • Rekrytering
        • St. Marianna University School of Medicine Hospital
      • Sagamihara, Kanagawa, Japan
        • Rekrytering
        • Kitasato University Hospital
      • Sagamihara, Kanagawa, Japan
        • Rekrytering
        • JA Health Management Center Sagamihara
      • Yokohama, Kanagawa, Japan
        • Rekrytering
        • Yokohama City University Medical Center
    • Kochi
      • Kochi, Kochi, Japan
        • Rekrytering
        • Clinic Green House
      • Kochi, Kochi, Japan
        • Rekrytering
        • Japanese RedCross Society Kochi Red Cross Hospital
      • Kochi, Kochi, Japan
        • Rekrytering
        • Kochi Kenshin Clinic
    • Kyoto
      • Kyoto, Kyoto, Japan
        • Rekrytering
        • Kyoto University Hospital
      • Kyoto, Kyoto, Japan
        • Rekrytering
        • Kyoto Industrial Health Association
    • Mie-ken
      • Matsusaka, Mie-ken, Japan
        • Rekrytering
        • Matsusaka Medical Association
      • Tsu, Mie-ken, Japan
        • Rekrytering
        • Mie University Hospital
      • Tsu, Mie-ken, Japan
        • Rekrytering
        • Mie Healthcare center
    • Oita Prefecture
      • Yufu, Oita Prefecture, Japan
        • Rekrytering
        • Oita University Hospital
    • Okinawa
      • Okinawa, Okinawa, Japan
        • Rekrytering
        • Nakagami General Chibana Clinic
      • Okinawa, Okinawa, Japan
        • Rekrytering
        • Nakagami Hospital
      • Shimajiri-gun Haebaru-cho, Okinawa, Japan
        • Rekrytering
        • Okinawa Health Promotion Foundation
    • Osaka
      • Osaka, Osaka, Japan
        • Rekrytering
        • NEO Healthcare GI Endoscopy Clinic Honmachi
      • Osaka, Osaka, Japan
        • Rekrytering
        • Tane Clinic
      • Osaka, Osaka, Japan
        • Rekrytering
        • Tane General Hospital
    • Saitama
      • Saitama, Saitama, Japan
        • Rekrytering
        • Jichi Medical University Saitama Medical Center
    • Shiga
      • Ōtsu, Shiga, Japan
        • Rekrytering
        • Shiga University of Medical Science Hospital
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan
        • Rekrytering
        • Seirei Hamamatsu General Hospital
      • Hamamatsu, Shizuoka, Japan
        • Rekrytering
        • Seirei Preventive Health Care Center
    • Tokyo
      • Chuo-ku, Tokyo, Japan
        • Rekrytering
        • Medical Check Studio Tokyo Ginza Clinic
      • Itabashi-ku, Tokyo, Japan
        • Rekrytering
        • C'est la vie Shinbashi Clinic
      • Itabashi-ku, Tokyo, Japan
        • Rekrytering
        • Nihon University Itabashi Hospital
      • Koganei, Tokyo, Japan
        • Rekrytering
        • Koganei Tsurukame Clinic
      • Minato-ku, Tokyo, Japan
        • Rekrytering
        • The Jikei University Hospital
      • Shinjuku-ku, Tokyo, Japan
        • Rekrytering
        • Tokyo Women's Medical University Hospital
      • Shinjuku-ku, Tokyo, Japan
        • Rekrytering
        • Miraza Shinjuku Tsurukame Clinic
      • Shinjuku-ku, Tokyo, Japan
        • Rekrytering
        • Shinjuku Tsurukame Clinic
    • Wakayama
      • Wakayama, Wakayama, Japan
        • Rekrytering
        • Wakayama Medical University Hospital
    • Yamagata
      • Yamagata, Yamagata, Japan
        • Rekrytering
        • Yamagata University Hospital
      • Yamagata, Yamagata, Japan
        • Rekrytering
        • Public Interest Incorporated Foundation Yamagata Health Promotion Organization

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

Inclusion Criteria:

  • Asymptomatic adults attending participating facilities for routine health checkups, organized cancer screening, or both
  • Able to understand the study procedures and provide written informed consent before enrollment

Exclusion Criteria:

  • Documented clinical history of pancreatic cancer
  • Considered unable or unwilling to undergo any required diagnostic imaging modality (MRCP, EUS, or contrast-enhanced CT) after a positive index test result
  • Any medical, psychological, or social condition that, in the opinion of the principal investigator at each participating site, makes participation inappropriate or compromises study integrity

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Undersökning
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Enzeavour Screening Pathway
Participants undergo peripheral blood collection for the Enzeavour Pancreatic Cancer assay as part of a routine health checkup or organized cancer screening visit. Participants with a positive assay result, defined as an Enzeavour Score greater than 0.369, are referred for diagnostic work-up, including MRCP, EUS, or contrast-enhanced CT, as clinically indicated.
Diagnostiskt test: Enzeavour Pancreatic Cancer Assay
A blood-based diagnostic assay that quantifies the activity of three specific enzymes at a single-molecule level. Four biomarkers derived from these measurements are integrated into a composite Enzeavour Score using a predefined discriminant function. Participants with a score above the pre-specified cut-off of 0.369 are considered test-positive and referred for diagnostic work-up.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pancreatic Cancer Detection Rate
Tidsram: Within 12 months after the index blood draw
The proportion of all enrolled participants diagnosed with pancreatic cancer within 12 months of the index blood draw. A confirmed case is defined as pancreatic cancer confirmed histopathologically or cytologically, or clinically diagnosed based on multidisciplinary team judgment.
Within 12 months after the index blood draw

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Positive Predictive Value of the Enzeavour Assay
Tidsram: Within 12 months after the index blood draw
The proportion of participants with a positive index test result, defined as an Enzeavour Score greater than 0.369, who are subsequently diagnosed with histopathologically confirmed pancreatic cancer within 12 months after the index blood draw.
Within 12 months after the index blood draw

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Detection Rates of Other Pancreatic Diseases and High-Risk Radiological Findings
Tidsram: Within 12 months after the index blood draw
Descriptive analysis of detection rates for various pancreatic diseases and high-risk radiological findings identified during diagnostic work-up and follow-up.
Within 12 months after the index blood draw
Comparison With Conventional Tumor Markers
Tidsram: Baseline through 12 months
Comparison of positivity rates and detection rates between the Enzeavour assay and conventional tumor markers, including CA19-9, overall and within the Enzeavour-positive subgroup.
Baseline through 12 months
Imaging Correlates of Assay Results
Tidsram: Baseline through 12 months
Comparative analysis of MRCP findings according to assay status and retrospective re-evaluation of baseline imaging in confirmed cancer cases.
Baseline through 12 months
Preliminary Longitudinal Performance Measures
Tidsram: 365 days after the index blood draw
Descriptive estimation of specificity and incidence rates for pancreatic and extra-pancreatic malignancies during follow-up.
365 days after the index blood draw

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Cosomil, Inc.

Utredare

  • Huvudutredare: Keiji Hanada, MD, Ph.D., JA Onomichi General Hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

4 februari 2026

Primärt slutförande (Beräknad)

31 december 2027

Avslutad studie (Beräknad)

31 december 2028

Studieregistreringsdatum

Först inskickad

11 maj 2026

Först inskickad som uppfyllde QC-kriterierna

18 maj 2026

Första postat (Faktisk)

26 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • A250007-T (Annan identifierare: Kobe University Hospital Interventional Research Ethics Committee)
  • JPNP23019 (Annat bidrag/finansieringsnummer: The New Energy and Industrial Technology Development Organization (NEDO))
  • UMIN000059647 (Registeridentifierare: University hospital Medical Information Network (UMIN) Center)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Individual participant data will not be made publicly available.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera