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NCT Number: NCT03082976

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 (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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Research Site

Al Ain City, United Arab Emirates

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of somatic BRCA mutations among ovarian cancer patients

    Time frame: 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

Secondary outcomes

  1. Associations or correspondence in prevalence between genetic alterations

    Time frame: 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

  2. Describe epidemiological characteristics

    Time frame: Up to 4 Weeks for BRCA testing result

    Describe epidemiological characteristics (e.g., age, ethnicities) of patients being treated for ovarian cancer.

  3. Describe treatment modalities

    Time frame: 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

  4. Categorize epideimiological charactersitics and clinical features

    Time frame: Up to 4 Weeks for BRCA testing result

    Describe epidemiological characteristics(e.g. Comorbidities, stage) of patients being treated for ovarian cancer

Other outcomes

  1. Compare standards of care practices

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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.

Acronym: PREDICT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 17, 2017
Registry last updated
Jul 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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