- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03082976
Prevalence of BRCA1 and BRCA2 Mutations in Ovarian Cancer Patients in the Gulf Region (PREDICT)
PREDICT: Prevalence of BRCA1 and BRCA2 Mutations in Ovarian Cancer Patients in the Gulf Region. A Prospective, Multi-centre, Epidemiological Observational Study Designed to Evaluate the Prevalence of BRCA1 and BRCA2 Mutations in Current and Newly Diagnosed Ovarian Cancer Patients Across Different Countries in the Gulf Region. This Study Study Will Also Describe the Epidemiological Features for the Disease for the Enrolled Patients.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Al Ain, Vereinigte Arabische Emirate
- Research Site
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Subjects willing to sign the informed consent form (ICF)
- Female subjects 18 years of age or older
Have histologically confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) ovarian epithelial, primary peritoneal cancer made by one or more of the following:
- Standard staging laparotomy including bilateral salpingo-oophorectomy,omentectomy, and lymph node sampling and debulking and/or
- Surgical resection and radiographic evidence consistent with ovarian cancer
- Paracentesis or biopsy with radiographic evidence consistent with ovarian cancer(normal appearing pancreas, liver, and gastrointestinal tract).
- Have availability of paraffin-embedded archived tumor tissue block (preferred) or, if a block is not possible, a minimum of twenty 10-um sections.
Exclusion Criteria:
Patients who meet any of the following criteria are ineligible to participate in the study and hence will not be consented:
- The diagnosis is not of a primary ovarian cancer; thus, patients will be excluded if a previous cancer has metastasized to the ovary, or if there is a secondary malignancy that is associated with the ovarian cancer.
- Is not able or willing to provide written informed consent.
- 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.
- Be a patient who, in the judgment of the Investigator, would be inappropriate for enrollment in this study.
A rationale will be documented for all patients who are screened and ultimately excluded from the study as a result of meeting any of the aforementioned exclusion criteria
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Prevalence of somatic BRCA mutations among ovarian cancer patients
Zeitfenster: Up to 4 Weeks for BRCA testing result
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The primary objective of this study is to discern the prevalence of somatic BRCA1 and BRCA2 mutations in patients with ovarian cancer, peritoneal cancer, and fallopian tube cancer, as assessed by tissue genetic testing in tumor samples
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Up to 4 Weeks for BRCA testing result
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Associations or correspondence in prevalence between genetic alterations
Zeitfenster: Up to 4 Weeks for BRCA testing result
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Examine associations (or correspondence) in prevalence between genetic alterations in hereditary (germline) and tissue (somatic) BRCA mutations by testing for germline (blood) mutations in those patients who are known to have somatic mutations
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Up to 4 Weeks for BRCA testing result
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Describe epidemiological characteristics
Zeitfenster: Up to 4 Weeks for BRCA testing result
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Describe epidemiological characteristics (e.g., age, ethnicities) of patients being treated for ovarian cancer.
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Up to 4 Weeks for BRCA testing result
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Describe treatment modalities
Zeitfenster: Up to 4 Weeks for BRCA testing result
|
Describe treatment strategy among the treatment-experienced subgroup of patients who were previously diagnosed with ovarian cancer
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Up to 4 Weeks for BRCA testing result
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Categorize epideimiological charactersitics and clinical features
Zeitfenster: Up to 4 Weeks for BRCA testing result
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Describe epidemiological characteristics(e.g.
Comorbidities, stage) of patients being treated for ovarian cancer
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Up to 4 Weeks for BRCA testing result
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Compare standards of care practices
Zeitfenster: Up to 4 Weeks for BRCA testing result
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An exploratory objective is to compare standards of care and pre- and post-diagnosis practices in each country, for example, with respect to tissue collection, processing, storage and maintenance, which is of great importance to future studies building on the present study.
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Up to 4 Weeks for BRCA testing result
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Mohammed Jaloudi, MD, Tawam Hospital
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen nach histologischem Typ
- Neubildungen
- Urogenitale Neoplasmen
- Neubildungen nach Standort
- Karzinom
- Neubildungen, Drüsen und Epithelien
- Genitale Neubildungen, weiblich
- Erkrankungen des endokrinen Systems
- Eierstockerkrankungen
- Adnexerkrankungen
- Gonadenstörungen
- Neoplasmen der endokrinen Drüse
- Eierstocktumoren
- Karzinom, Eierstockepithel
Andere Studien-ID-Nummern
- D133FR00118
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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