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Prevalence of BRCA1 and BRCA2 Mutations in Ovarian Cancer Patients in the Gulf Region (PREDICT)

15. juli 2020 oppdatert av: AstraZeneca

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.

A prospective, multi-centre, epidemiological observational study designed to evaluate the prevalence of BRCA1 and BRCA2 (BReast CAncer gene) mutations in current and newly diagnosed ovarian cancer patients across different countries in the Gulf region. This study will also describe the epidemiological features for the disease for the enrolled patients.

Studieoversikt

Status

Fullført

Forhold

Studietype

Observasjonsmessig

Registrering (Faktiske)

108

Kontakter og plasseringer

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

Studiesteder

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

The target study population will be women at least 18 years of age with histologically confirmed ovarian, peritoneal, and fallopian tube cancers at participating oncology hospitals/departments in the Gulf region. Patients enrolled in this study will be assigned to either the treatment-experienced subgroup for those who were previously diagnosis and are undergoing treatment at the time of enrollment, or the treatment-native group for those who were recently diagnosed and not yet undergoing treatment.

Beskrivelse

Inclusion Criteria:

  1. Subjects willing to sign the informed consent form (ICF)
  2. Female subjects 18 years of age or older
  3. Have histologically confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) ovarian epithelial, primary peritoneal cancer made by one or more of the following:

    1. Standard staging laparotomy including bilateral salpingo-oophorectomy,omentectomy, and lymph node sampling and debulking and/or
    2. Surgical resection and radiographic evidence consistent with ovarian cancer
    3. Paracentesis or biopsy with radiographic evidence consistent with ovarian cancer(normal appearing pancreas, liver, and gastrointestinal tract).
  4. 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:

  1. 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.
  2. Is not able or willing to provide written informed consent.
  3. 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.
  4. 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

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

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prevalence of somatic BRCA mutations among ovarian cancer patients
Tidsramme: 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
Up to 4 Weeks for BRCA testing result

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Associations or correspondence in prevalence between genetic alterations
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Compare standards of care practices
Tidsramme: 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

Samarbeidspartnere og etterforskere

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

Sponsor

Etterforskere

  • Hovedetterforsker: Mohammed Jaloudi, MD, Tawam Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

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)

16. juli 2017

Primær fullføring (Faktiske)

24. juli 2019

Studiet fullført (Faktiske)

24. juli 2019

Datoer for studieregistrering

Først innsendt

27. februar 2017

Først innsendt som oppfylte QC-kriteriene

13. mars 2017

Først lagt ut (Faktiske)

17. mars 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. juli 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. juli 2020

Sist bekreftet

1. juli 2020

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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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