Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Establishment of Scoring Model for Early and Differential Diagnosis of Intrahepatic Cholangiocarcinoma

7. april 2022 opdateret af: Yanjing Gao, Qilu Hospital of Shandong University

Establishment of Scoring Model for Early Diagnosis and Differential Diagnosis of Intrahepatic Cholangiocarcinoma

The purpose of this study is to develop and validate a radiological nomogram including radiological characteristics, clinical risk factors, and medical history. And we aim to establish a noninvasive method for the diagnosis of intrahepatic cholangiocarcinoma (ICC), and to construct a differential diagnosis model for ICC and hepatocellular carcinoma (HCC) with higher sensitivity and accuracy.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

In recent years, the incidence and mortality of intrahepatic cholangiocarcinoma (ICC) have been increasing worldwide. Due to the different treatment options for hepatocellular carcinoma (HCC) and ICC, accurate differential diagnosis is critical for subsequent treatment of patients. However, because of their similar CT image enhancement patterns, they are easily misdiagnosed by clinicians, leading to an incorrect treatment. Based on the above research background, our objective is to establish a noninvasive method for the diagnosis of ICC and and to construct a differential diagnosis model for ICC and HCC with higher sensitivity and accuracy.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

300

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Shandong
      • Jinan, Shandong, Kina, 250012
        • Rekruttering
        • Department of Gastroenterology,Qilu Hospital,Shandong University
        • Kontakt:

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 til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Clinical data of patients in hospitals in the past 10 years were retrospectively collected. Pathological database from September 2010 to July 2021 was searched. Patients with definite pathological diagnosis of ICC or HCC were determined as the training group, and patients from September 2021 to September 2023 were prospectively collected as the validation group.

Beskrivelse

Inclusion Criteria:

  1. patients with pathological confirmation of ICC or HCC,
  2. CT was performed less than 15 days before surgery,
  3. Patients with complete clinical data.

Exclusion Criteria:

  1. history of other tumors,
  2. Metastatic liver cancer,
  3. Patients received preoperative chemotherapy or radiotherapy,
  4. Image quality analysis is not ideal.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Training cohort
Training cohort consists of the patients diagnosed with intrahepatic cholangiocarcinoma who collected from January 2010 to July 2021 retrospectively.
Internal validation cohort
Internal validation cohort consists of the intrahepatic cholangiocarcinoma patients who enrolled from September 2021 of Qilu Hospital prospectively.
External validation cohort
External validation cohort consists of the intrahepatic cholangiocarcinoma patients who enrolled from September 2021 of Shandong Province Hospital, Jinan Military General Hospital and Jinan Central Hospital prospectively.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Accuracy
Tidsramme: through study completion, up to 2 years
The golden standard is the pathological biopsy.Compare the accuracy of the noninvasive model with the pathological biopsy.
through study completion, up to 2 years
sensitivity
Tidsramme: through study completion, up to 2 years
Sensitivity of noninvasive model for diagnosis of intrahepatic cholangiocarcinoma.
through study completion, up to 2 years
specificity
Tidsramme: through study completion, up to 2 years
Specificity of noninvasive model for diagnosis of intrahepatic cholangiocarcinoma.
through study completion, up to 2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Qilu Hospital of Shandong University

Samarbejdspartnere

Shandong Provincial Hospital
Jinan Military General Hospital
Jinan Central Hospital

Efterforskere

  • Ledende efterforsker: Yanjing Gao, PhD.MD, Qilu Hospital, Shandong University

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)

22. november 2020

Primær færdiggørelse (Forventet)

22. februar 2023

Studieafslutning (Forventet)

22. maj 2023

Datoer for studieregistrering

Først indsendt

7. april 2022

Først indsendt, der opfyldte QC-kriterier

7. april 2022

Først opslået (Faktiske)

14. april 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. april 2022

Sidst verificeret

1. april 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 202135719-Qilu

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Intrahepatisk cholangiocarcinom

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Bosnia & Herzegovina

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner