- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03203993
China Ovarian Cancer BRCA Testing Study (CRONUS)
China Local BRCA Testing and Exploration of Ovarian Cancer Treatment Outcomes of Different BRCA Status in Newly Diagnosed Epithelial Ovarian Cancer Patients
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Hong Kong, Hong Kong
- Research Site
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Anhui
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Hefei, Anhui, Kina, 230601
- Research Site
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Beijing
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Beijing, Beijing, Kina, 100142
- Research Site
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Beijing, Beijing, Kina, 100191
- Research Site
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Beijing, Beijing, Kina, 100730
- Research Site
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Chongqing
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Chongqing, Chongqing, Kina, 400030
- Research Site
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Guangdong
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Guangzhou, Guangdong, Kina, 510060
- Research Site
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Guangzhou, Guangdong, Kina, 510080
- Research Site
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Guangzhou, Guangdong, Kina, 510220
- Research Site
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Henan
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Zhengzhou, Henan, Kina, 450008
- Research Site
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Hubei
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Wuhan, Hubei, Kina, 430030
- Research Site
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Hunan
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Changsha, Hunan, Kina, 410000
- Research Site
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Shandong
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Jinan, Shandong, Kina, 250014
- Research Site
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Shanghai
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Shanghai, Shanghai, Kina, 200032
- Research Site
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Shanghai, Shanghai, Kina, 200080
- Research Site
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Sichuan
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Chengdu, Sichuan, Kina, 610041
- Research Site
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Tianjin
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Tianjin, Tianjin, Kina, 300110
- Research Site
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Tianjin, Tianjin, Kina, 300202
- Research Site
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310006
- Research Site
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Crossover
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Proportion of newly diagnosed ovarian cancer patients with gBRCA and sBRCA mutations
Tidsramme: 1 year
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To evaluate the prevalence of gBRCA mutation and sBRCA mutation in newly diagnosed ovarian cancer patients
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1 year
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Progression-free survival (PFS)
Tidsramme: 18 months
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To describe ovarian cancer treatment outcomes in patients during the Follow up Period in terms of PFS
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18 months
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Overall survival (OS)
Tidsramme: up to 5 years
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To describe ovarian cancer treatment outcomes in patients during the Follow up Period in terms of OS
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up to 5 years
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Proportion of newly diagnosed ovarian cancer patients with HRR gene mutations
Tidsramme: 1 year
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To evaluate the prevalence of homologous recombination repair (HRR) gene mutations in newly diagnosed ovarian cancer patients
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1 year
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Jinghe Lang, Dr, Peking Union Medical College Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Karcinom
- Neoplasmer, kirtel og epitel
- Genitale neoplasmer, kvindelige
- Sygdomme i det endokrine system
- Ovariesygdomme
- Adnexale sygdomme
- Gonadale lidelser
- Neoplasmer i endokrine kirtler
- Ovariale neoplasmer
- Karcinom, ovarieepitel
Andre undersøgelses-id-numre
- D133FR00117
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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.
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- Studieprotokol
- Statistisk analyseplan (SAP)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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