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

23. juni 2026 oppdatert 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

10000

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Screening
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Diagnostisk 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pancreatic Cancer Detection Rate
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Positive Predictive Value of the Enzeavour Assay
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Detection Rates of Other Pancreatic Diseases and High-Risk Radiological Findings
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Cosomil, Inc.

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. februar 2026

Primær fullføring (Antatt)

31. desember 2027

Studiet fullført (Antatt)

31. desember 2028

Datoer for studieregistrering

Først innsendt

11. mai 2026

Først innsendt som oppfylte QC-kriteriene

18. mai 2026

Først lagt ut (Faktiske)

26. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • A250007-T (Annen identifikator: Kobe University Hospital Interventional Research Ethics Committee)
  • JPNP23019 (Annet stipend/finansieringsnummer: The New Energy and Industrial Technology Development Organization (NEDO))
  • UMIN000059647 (Registeridentifikator: University hospital Medical Information Network (UMIN) Center)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be made publicly available.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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