Ovarian CancerPREDICTNCT03082976
Prevalence of BRCA1 and BRCA2 Mutations in Ovarian Cancer Patients in the Gulf Region
An observational study of Ovarian Cancer, run by AstraZeneca at 1 site in United Arab Emirates.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 108 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 16 Jul 2017to 24 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
- Conditions
- Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of somatic BRCA mutations among ovarian cancer patients
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
Measured: Up to 4 Weeks for BRCA testing result
Secondary outcomes (4)
Associations or correspondence in prevalence between genetic alterations
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
Measured: Up to 4 Weeks for BRCA testing result
Describe epidemiological characteristics
Describe epidemiological characteristics (e.g., age, ethnicities) of patients being treated for ovarian cancer.
Measured: Up to 4 Weeks for BRCA testing result
Describe treatment modalities
Describe treatment strategy among the treatment-experienced subgroup of patients who were previously diagnosed with ovarian cancer
Measured: Up to 4 Weeks for BRCA testing result
Categorize epideimiological charactersitics and clinical features
Describe epidemiological characteristics(e.g. Comorbidities, stage) of patients being treated for ovarian cancer
Measured: Up to 4 Weeks for BRCA testing result
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start16 Jul 2017
- Primary completion24 Jul 2019
- Study completion24 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohammed Jaloudi, MD, Principal investigator, Tawam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082976
- Sponsor's protocol ID
- D133FR00118
- Acronym
- PREDICT
- Status last verified
- Jul 2020
- First submitted
- 27 Feb 2017
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Azribi F, Abdou E, Dawoud E, Ashour M, Kamal A, Al Sayed M, Burney I. Prevalence of BRCA1 and BRCA2 pathogenic sequence variants in ovarian cancer patients in the Gulf region: the PREDICT study. BMC Cancer. 2021 Dec 20;21(1):1350. doi: 10.1186/s12885-021-09094-8.
PubMed 34930165
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT03082976
- Acronym / sponsor ID
- PREDICT / D133FR00118
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2017 (actual)
- Primary completion
- 24 Jul 2019 (actual)
- Study completion
- 24 Jul 2019 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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:
- Have availability of paraffin-embedded archived tumor tissue block (preferred) or, if a block is not possible, a minimum of twenty 10-um sections.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Associations or correspondence in prevalence between genetic alterations
Time frame: Up to 4 Weeks for BRCA testing result
Describe epidemiological characteristics
Time frame: Up to 4 Weeks for BRCA testing result
Describe treatment modalities
Time frame: Up to 4 Weeks for BRCA testing result
Categorize epideimiological charactersitics and clinical features
Time frame: Up to 4 Weeks for BRCA testing result
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Derived from this study: PubMed 34930165Azribi F, Abdou E, Dawoud E, Ashour M, Kamal A, Al Sayed M, Burney I. Prevalence of BRCA1 and BRCA2 pathogenic sequence variants in ovarian cancer patients in the Gulf region: the PREDICT study. BMC Cancer. 2021 Dec 20;21(1):1350. doi: 10.1186/s12885-021-09094-8.
- Redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed Jaloudi, MD principal investigator
Tawam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by AstraZeneca at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of somatic BRCA mutations among ovarian cancer patients (time frame: Up to 4 Weeks for BRCA testing result). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03082976, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.