Ovarian NeoplasmsFindBRCANessNCT02524808
Prospective Identification and Validation of "BRCANess" Profile in Ovarian Epithelial Cancer
An observational study of Ovarian Neoplasms, run by Fundación de investigación HM at 4 sites in Spain.
Trial summary
This is an observational prospective study. Patients diagnosed with advanced epithelial ovarian cancer (stage IC or higher) since 2008 will be asked to participate in this study by signing an informed consent. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Neoplasms
- How many people
- 230 participants
- Where
- 4 sitesSpain
- Study dates
- Aug 2015to Jul 2016
- How long will I take part?
- 6 Months
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with advanced epithelial ovarian cancer (stage 1c or higher) since 2008
Who may be able to join
- Patients diagnosed with advanced epithelial ovarian cancer (stage IC or higher).
Who cannot join
- Non
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital Universitario Severo Ochoa
Leganés, Madrid
Hospital Universitario HM Sanchinarro - Clara Campal Comprehensive Cancer Center
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Complejo Hospitalario de Navarra
Pamplona
About this study
Official title: Multicentric Project for the Prospective Identification and Validation of Molecular Alterations That Define the "BRCANess" Profile in Ovarian Epithelial Cancer and Its Application as a Response Predictor to Platinum and Antitarget Therapies in the Clinical Practice. The Finding BRCANess Project
This is an observational prospective study. Patients diagnosed with advanced epithelial ovarian cancer (stage IC or higher) since 2008 will be asked to participate in this study by signing an informed consent. Tumour samples will be reviewed to confirm the diagnosis and to select the best regions for tissue sampling to perform the following molecular studies: array-based Comparative Genomic Hybridization and Next Generation Sequencing. Detected mutations will be analysed by Sanger sequencing. FISH probes will be designed and tested on the samples.
- Conditions
- Ovarian Neoplasms
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a genetic profile defined by sequencing that could predict Progression Free Survival (PFS)
Clinical data from the enrolled patients will be recorded and related to the results obtained from sequencing the DNA isolated from tumor samples. Whole exome sequencing (WES) will be used for sequencing DNA isolated from paraffin embedded samples and Whole genome association study (GWAS) for the DNA from frozen samples. The bioinformatics analysis of the sequencing results will allow us to identify altered regions and affected genes and the minimal common regions of imbalance. All detected mutations will be confirmed by Sanger sequencing to ensure the reliability of the findings.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2015 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 230 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Fundación de investigación HM
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524808
- Sponsor's protocol ID
- ESR-14-10537
- Acronym
- FindBRCANess
- Status last verified
- Aug 2015
- First submitted
- 6 Aug 2015
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Project for the Prospective Identification and Validation of Molecular Alterations That Define the "BRCANess" Profile in Ovarian Epithelial Cancer and Its Application as a Response Predictor to Platinum and Antitarget Therapies in the Clinical Practice. The Finding BRCANess Project
- ClinicalTrials.gov ID
- NCT02524808
- Acronym / sponsor ID
- FindBRCANess / ESR-14-10537
- Conditions
- Ovarian Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Fundación de investigación HMUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 17 Aug 2015 (estimated)
- 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.
This is an observational prospective study. Patients diagnosed with advanced epithelial ovarian cancer (stage IC or higher) since 2008 will be asked to participate in this study by signing an informed consent. Tumour samples will be reviewed to confirm the diagnosis and to select the best regions for tissue sampling to perform the following molecular studies: array-based Comparative Genomic Hybridization and Next Generation Sequencing. Detected mutations will be analysed by Sanger sequencing. FISH probes will be designed and tested on the samples.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with advanced epithelial ovarian cancer (stage 1c or higher) since 2008
Key inclusion criteria (1 listed)
- Patients diagnosed with advanced epithelial ovarian cancer (stage IC or higher).
Key exclusion criteria (1 listed)
- Non
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
Number of participants with a genetic profile defined by sequencing that could predict Progression Free Survival (PFS)
Time frame: 1 year
Clinical data from the enrolled patients will be recorded and related to the results obtained from sequencing the DNA isolated from tumor samples. Whole exome sequencing (WES) will be used for sequencing DNA isolated from paraffin embedded samples and Whole genome association study (GWAS) for the DNA from frozen samples. The bioinformatics analysis of the sequencing results will allow us to identify altered regions and affected genes and the minimal common regions of imbalance. All detected mutations will be confirmed by Sanger sequencing to ensure the reliability of the findings.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Neoplasms, run by Fundación de investigación HM at 4 sites in Spain.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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?
Results are not available in the source record.
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?
Number of participants with a genetic profile defined by sequencing that could predict Progression Free Survival (PFS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2015.