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China Ovarian Cancer BRCA Testing Study (CRONUS)

13. oktober 2020 oppdatert av: AstraZeneca

China Local BRCA Testing and Exploration of Ovarian Cancer Treatment Outcomes of Different BRCA Status in Newly Diagnosed Epithelial Ovarian Cancer Patients

This is a prospective, multi-center, observational study, the primary objective is to evaluate the prevalence of gBRCA/sBRCAm in newly diagnosed ovarian cancer patients and explore ovarian cancer treatment outcomes of different BRCAm status

Studieoversikt

Status

Avsluttet

Forhold

Detaljert beskrivelse

This is a prospective, multi-center, observational study that will enroll consecutive patients with a confirmed diagnosis of epithelial ovarian cancer, fallopian tube, or peritoneal cancer and who consent to a blood draw, a tissue sample analysis, and follow up for collection of data. 900 newly diagnosed ovarian cancer patients will be enrolled and evaluated for Breast Cancer Susceptibility genes BRCA1 and BRCA2 germline and somatic mutations (BRCAm). Approximately 170 BRCAm positive patients and 170 negative patients will be followed in the Follow-up Period. This study aims to answer very important questions regarding the prevalence of gBRCAm and sBRCAm in a population of newly diagnosed ovarian cancer patients, and the relationship of these mutations to patient treatment and clinical outcomes. These answers may be extremely helpful in the counseling and treatment of genetic risk in these populations and may aid in making treatment decisions in the future.

Studietype

Observasjonsmessig

Registrering (Faktiske)

29

Kontakter og plasseringer

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

Studiesteder

  • Hong Kong
      • Hong Kong, Hong Kong
        • Research Site
  • Kina
    • Anhui
      • Hefei, Anhui, Kina, 230601
        • Research Site
    • Beijing
      • Beijing, Beijing, Kina, 100142
        • Research Site
      • Beijing, Beijing, Kina, 100191
        • Research Site
      • Beijing, Beijing, Kina, 100730
        • Research Site
    • Chongqing
      • Chongqing, Chongqing, Kina, 400030
        • Research Site
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510060
        • Research Site
      • Guangzhou, Guangdong, Kina, 510080
        • Research Site
      • Guangzhou, Guangdong, Kina, 510220
        • Research Site
    • Henan
      • Zhengzhou, Henan, Kina, 450008
        • Research Site
    • Hubei
      • Wuhan, Hubei, Kina, 430030
        • Research Site
    • Hunan
      • Changsha, Hunan, Kina, 410000
        • Research Site
    • Shandong
      • Jinan, Shandong, Kina, 250014
        • Research Site
    • Shanghai
      • Shanghai, Shanghai, Kina, 200032
        • Research Site
      • Shanghai, Shanghai, Kina, 200080
        • Research Site
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • Research Site
    • Tianjin
      • Tianjin, Tianjin, Kina, 300110
        • Research Site
      • Tianjin, Tianjin, Kina, 300202
        • Research Site
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310006
        • Research Site

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

18 år til 130 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

newly diagnosed epithelial ovarian cancer patients

Beskrivelse

Inclusion Criteria:

  • Be able and willing to sign the informed consent form (ICF)
  • Female aged 18 years or over

  • Have histologically confirmed new diagnosis of Federation of Gynecology and Obstetrics (FIGO) stage III or IV ovarian epithelial, primary peritoneal, or fallopian tube cancer made by one or more of the following:

    • standard staging laparotomy including bilateral salpingo-oophorectomy, omentectomy, and lymph node sampling and debulkingand/or
    • surgical resection and radiographic evidence consistent with Stage III or IV ovarian cancer
    • biopsy with radiographic evidence consistent with Stage III or IV ovarian cancer
  • Have availability of paraffin-embedded archivedtumor tissue block (preferred) or,if a block is not possible, a minimum of twenty 5-μm unstained sections. (Tumor tissue should be archived at diagnosis. 10 slides is utilized for sBRCA testing after the enrolment. Another 10 slides is utilized for exploratory evaluation of HRR gene mutations in a retrospective way.)
  • Have a diagnosis that is within 60 days of informed consent

Exclusion Criteria:

  • Have a diagnosis of additional concurrent malignancies or previous diagnosis of another malignancy with current evidence of residual disease
  • Have a diagnosis of other severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of the study results and, in the judgement of the Investigator, would make the patient inappropriate for enrollment in this study
  • Be currently participating in any other clinical trial for first-line treatment of ovarian cancer
  • Be a patient who, in the judgement of the Investigator, would be inappropriate for enrollment in this study

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Case-Crossover
  • Tidsperspektiver: Potensielle

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of newly diagnosed ovarian cancer patients with gBRCA and sBRCA mutations
Tidsramme: 1 year
To evaluate the prevalence of gBRCA mutation and sBRCA mutation in newly diagnosed ovarian cancer patients
1 year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-free survival (PFS)
Tidsramme: 18 months
To describe ovarian cancer treatment outcomes in patients during the Follow up Period in terms of PFS
18 months
Overall survival (OS)
Tidsramme: up to 5 years
To describe ovarian cancer treatment outcomes in patients during the Follow up Period in terms of OS
up to 5 years

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of newly diagnosed ovarian cancer patients with HRR gene mutations
Tidsramme: 1 year
To evaluate the prevalence of homologous recombination repair (HRR) gene mutations in newly diagnosed ovarian cancer patients
1 year

Samarbeidspartnere og etterforskere

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

Sponsor

AstraZeneca

Etterforskere

  • Studiestol: Jinghe Lang, Dr, Peking Union Medical College Hospital

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)

31. januar 2018

Primær fullføring (Faktiske)

31. mars 2020

Studiet fullført (Faktiske)

31. mars 2020

Datoer for studieregistrering

Først innsendt

23. juni 2017

Først innsendt som oppfylte QC-kriteriene

27. juni 2017

Først lagt ut (Faktiske)

29. juni 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. oktober 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. oktober 2020

Sist bekreftet

1. oktober 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • D133FR00117

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ja

IPD-planbeskrivelse

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-delingstidsramme

AstraZeneca has a long-standing commitment to making information about our clinical research publicly available. We believe that transparency enhances the scientific understanding of how our medicines work and is in the medical interest of our patients.

We publish information on the registration and results of all new and ongoing AstraZeneca sponsored clinical trials for all products in all phases, including marketed medicines, drugs in development and drugs whose further development has been discontinued. We post results, irrespective of whether they are favourable or unfavourable to AstraZeneca.

Tilgangskriterier for IPD-deling

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-deling Støtteinformasjonstype

  • Studieprotokoll
  • Statistisk analyseplan (SAP)

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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