- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
-
Al Ain, Förenade arabemiraten
- Research Site
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Prevalence of somatic BRCA mutations among ovarian cancer patients
Tidsram: Up to 4 Weeks for BRCA testing result
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Associations or correspondence in prevalence between genetic alterations
Tidsram: Up to 4 Weeks for BRCA testing result
|
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
|
Up to 4 Weeks for BRCA testing result
|
|
Describe epidemiological characteristics
Tidsram: Up to 4 Weeks for BRCA testing result
|
Describe epidemiological characteristics (e.g., age, ethnicities) of patients being treated for ovarian cancer.
|
Up to 4 Weeks for BRCA testing result
|
|
Describe treatment modalities
Tidsram: 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
|
Up to 4 Weeks for BRCA testing result
|
|
Categorize epideimiological charactersitics and clinical features
Tidsram: Up to 4 Weeks for BRCA testing result
|
Describe epidemiological characteristics(e.g.
Comorbidities, stage) of patients being treated for ovarian cancer
|
Up to 4 Weeks for BRCA testing result
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Compare standards of care practices
Tidsram: Up to 4 Weeks for BRCA testing result
|
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.
|
Up to 4 Weeks for BRCA testing result
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Mohammed Jaloudi, MD, Tawam Hospital
Publikationer och användbara länkar
Användbara länkar
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
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
- D133FR00118
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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