- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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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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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Case-Crossover
- Tidsperspektiv: Blivande
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Proportion of newly diagnosed ovarian cancer patients with gBRCA and sBRCA mutations
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Progression-free survival (PFS)
Tidsram: 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)
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Proportion of newly diagnosed ovarian cancer patients with HRR gene mutations
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Jinghe Lang, Dr, Peking Union Medical College Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter histologisk typ
- Neoplasmer
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Carcinom
- Neoplasmer, körtel och epitel
- Genitala neoplasmer, hona
- Sjukdomar i det endokrina systemet
- Ovariella sjukdomar
- Adnexala sjukdomar
- Gonadal sjukdomar
- Neoplasmer i endokrina körtel
- Ovariella neoplasmer
- Karcinom, äggstocksepitel
Andra studie-ID-nummer
- D133FR00117
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- Studieprotokoll
- Statistisk analysplan (SAP)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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