Ovarian, Peritoneal, Fallopian Tube Cancer, BRCAm+ in RussiaOVATARNCT02122588
OVArian Cancer Non-Interventional Study - OVATAR
An observational study of Ovarian, Peritoneal, Fallopian Tube Cancer, BRCAm+ in Russia, run by AstraZeneca at 22 sites in Russia.
Trial summary
This is a multicentre, non-interventional, prospective study to be carried out in representative hospitals in order to assess 1st line treatment management and diagnostic approaches applied to ovarian, peritoneal and fallopian tube cancer management in Russia and assess patients' characteristics and the occurrence of… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian, Peritoneal, Fallopian Tube Cancer, BRCAm+ in Russia
- How many people
- 503 participants
- Where
- 22 sitesRussia
- Study dates
- 30 Jun 2014to 31 May 2018
- 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: Females with serous and endometrioid ovarian, peritoneal and fallopian tube cancer 18 years and older, diagnosed 3 months before enrolment into the study or later, consented to participate in this non-interventional study, who are being treated for OC, FTC and PC in the oncology hospitals/departments in the Russian Federation.
Who may be able to join
- The voluntary obtained informed consent signed by both the subject and the investigator.
- Confirmed serous and endometrioid ovarian cancer or fallopian tube cancer or peritoneal cancer diagnosed 3 months before enrolment into the study or later
- Patients on treatment for OC (Ovarian Cancer) or FTC (Fallopian Tube Cancer) or PC (Peritoneal Cancer)
Who cannot join
- The ovarian cancer histology other than serous and endometrioid.
- Patients participating in clinical studies.
- Any medical condition which on the opinion of the investigator may interfere the patient's participation in the trial.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Russia22 sites
Research Site
Arkhangelsk
Research Site
Chelyabinsk
Research Site
Irkutsk
Research Site
Izhevsk
Research Site
Kaluga
Research Site
Khabarovsk
Research Site
Moscow
Research Site
Novorossiysk
Research Site
Novosibirsk
Research Site
Obninsk
Research Site
Omsk
Research Site
Orenburg
Research Site
Pyatigorsk
Research Site
Rostov-on-Don
Research Site
Saint Petersburg
Research Site
Samara
Research Site
Sochi
Research Site
Tomsk
Research Site
Tula
Research Site
Tver'
Research Site
Ufa
Research Site
Vladimir
About this study
Official title: OVArian Cancer Non-Interventional Study. Treatment hAbits and Epidemiology of BRCA in Russian Federation - OVATAR
This is a multicentre, non-interventional, prospective study to be carried out in representative hospitals in order to assess 1st line treatment management and diagnostic approaches applied to ovarian, peritoneal and fallopian tube cancer management in Russia and assess patients' characteristics and the occurrence of BRCA (Breast Cancer gene) mutations among Russian women with serous and endometrioid ovarian, peritoneal and fallopian tube cancer. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.
Read the detailed description
This is a multicentre, non-interventional, prospective study to be carried out in representative hospitals in order to assess ovarian, fallopian tube and peritoneal cancer management in Russia. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.
It is planned to enrol 300 subjects in up to 30 sites in Russian Federation. The average number of patients per site is planned as 10-15; there are no restrictions on minimum and maximum number of subjects per site in this study.
The disease treatments approaches in 1st line treatment of serous and endometrioid ovarian, peritoneal and fallopian tube cancer (both chemotherapy and surgery) is considered as the primary outcome variable in this study.
Along with other diagnosis examinations the analysis of frequent mutations in the gen BRCA1 (5382insC, 4154delA, 185delAG and C61G (c.300T>G)) will be performed by local or regional laboratories.
Those patients with BRCAm+ OC (Ovarian Cancer) will be observed prospectively during 2 years after the baseline visit or till progression at the 1st line treatment with regards to OC treatment details and outcomes. The patients for whom BRCA mutations not found will participate in the baseline assessments only and will not be followed up. Accordingly, 1 study visit (screening/baseline) is planned for all patients and 1 FU visit (Year 2) is planned for BRCAm+ patients.
The subpopulation of the patients with the congenital serous and endometrioid ovarian, peritoneal and fallopian tube cancer with the corresponding family history will undergo the broadened genetic testing panel (sequencing of all coding areas of genes BRCA1 and BRCA2).
Information regarding patient demographics, the disease characteristics, management approaches, diagnostic tests performed and medication received by the patient will be taken from the medical records.
- Keywords
- serous and endometrioid ovarian, peritoneal, fallopian tube cancer, hereditary ovarian cancer, BRCA (breast cancer gene) mutation, genetic testing
- Medical subject headings
- Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OVATAR study patients | Females with serous and endometrioid ovarian, peritoneal and fallopian tube cancer 18 years and older, diagnosed 3 months before enrolment into the study or later, consented to participate in this non-interventional study, who are being treated for OC, FTC (Fallopian Tube Cancer) and PC (Peritoneal Cancer) in the oncology hospitals/departments in the Russian Federation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of 1st line chemotherapy treatment of serous and endometrioid ovarian, peritoneal and fallopian tube cancer (drugs by INN (International Nonproprietary Name), doses, regimen)
Evaluation of 1st line chemotherapy treatment of serous and endometrioid ovarian, peritoneal and fallopian tube cancer (drugs by INN, doses, regimen)
Measured: up to 14 months
Secondary outcomes (6)
Data collection of patients characteristics (gender, age, race, co-morbidities, family history of ovarian and breast cancer)
Data collection of patients characteristics (gender, age, race, co-morbidities, family history of ovarian and breast cancer)
Measured: up to 14 months
Data collection of disease information (including genetic testing results)
Data collection of disease information (including genetic testing results)
Measured: up to 14 months
Proportion of BRCAm+ among serous and endometrioid ovarian, peritoneal and fallopian tube cancer in Russia.
Proportion of BRCAm+ among serous and endometrioid ovarian, peritoneal and fallopian tube cancer in Russia.
Measured: up to 14 months
Evaluation of response to 1st line chemotherapy treatment of serous and endometrioid BRCAm+ ovarian, peritoneal and fallopian tube cancer
Evaluation of response to 1st line chemotherapy treatment of serous and endometrioid BRCAm+ ovarian, peritoneal and fallopian tube cancer
Measured: up to 3 months
Assessment of relapses after 1st line of Pt (Platinum)-containing regimen for BRCAm+ patients
Assessment of relapses after 1st line of Pt-containing regimen for BRCAm+ patients
Measured: up to 3 months
Evaluation of 2nd line chemotherapy treatment of serous and endometrioid ovarian, peritoneal and fallopian tube cancer (drugs by INN, doses, regimen) for BRCAm+ patients who have progressed after 1st line chemotherapy
Evaluation of 2nd line chemotherapy treatment of serous and endometrioid ovarian, peritoneal and fallopian tube cancer (drugs by INN, doses, regimen) for BRCAm+ patients who have progressed after 1st line chemotherapy
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study start30 Jun 2014
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian, Peritoneal, Fallopian Tube Cancer, BRCAm+ in RussiaStudies 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
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RUSSCO (Russian Society of Clinical Oncology)
- Responsible party
- Sponsor
- Investigators
- Karin Otter, Study director, AstraZenecaVera Gorbunova, Principal investigator, Russian Cancer Research Center named after NN BlokhinAlexandra Tyulandina, Principal investigator, Russian Cancer Research Center named after NN BlokhinLarisa Kolomietz, Study chair, Research Oncology Center, TomskTatiana Kekeeva, Study chair, Research Centre for Medical Genetics, Moscow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122588
- Sponsor's protocol ID
- NIS-ORU-XXX-2014/1
- Acronym
- OVATAR
- Status last verified
- May 2019
- First submitted
- 23 Apr 2014
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OVArian Cancer Non-Interventional Study. Treatment hAbits and Epidemiology of BRCA in Russian Federation - OVATAR
- ClinicalTrials.gov ID
- NCT02122588
- Acronym / sponsor ID
- OVATAR / NIS-ORU-XXX-2014/1
- Keywords
- serous and endometrioid ovarian, peritoneal, fallopian tube cancer, hereditary ovarian cancer, BRCA (breast cancer gene) mutation, genetic testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- RUSSCO (Russian Society of Clinical Oncology)
- Study start
- 30 Jun 2014 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 24 Apr 2014 (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 a multicentre, non-interventional, prospective study to be carried out in representative hospitals in order to assess 1st line treatment management and diagnostic approaches applied to ovarian, peritoneal and fallopian tube cancer management in Russia and assess patients' characteristics and the occurrence of BRCA (Breast Cancer gene) mutations among Russian women with serous and endometrioid ovarian, peritoneal and fallopian tube cancer. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.
Detailed description
This is a multicentre, non-interventional, prospective study to be carried out in representative hospitals in order to assess ovarian, fallopian tube and peritoneal cancer management in Russia. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.
It is planned to enrol 300 subjects in up to 30 sites in Russian Federation. The average number of patients per site is planned as 10-15; there are no restrictions on minimum and maximum number of subjects per site in this study.
The disease treatments approaches in 1st line treatment of serous and endometrioid ovarian, peritoneal and fallopian tube cancer (both chemotherapy and surgery) is considered as the primary outcome variable in this study.
Along with other diagnosis examinations the analysis of frequent mutations in the gen BRCA1 (5382insC, 4154delA, 185delAG and C61G (c.300T>G)) will be performed by local or regional laboratories.
Those patients with BRCAm+ OC (Ovarian Cancer) will be observed prospectively during 2 years after the baseline visit or till progression at the 1st line treatment with regards to OC treatment details and outcomes. The patients for whom BRCA mutations not found will participate in the baseline assessments only and will not be followed up. Accordingly, 1 study visit (screening/baseline) is planned for all patients and 1 FU visit (Year 2) is planned for BRCAm+ patients.
The subpopulation of the patients with the congenital serous and endometrioid ovarian, peritoneal and fallopian tube cancer with the corresponding family history will undergo the broadened genetic testing panel (sequencing of all coding areas of genes BRCA1 and BRCA2).
Information regarding patient demographics, the disease characteristics, management approaches, diagnostic tests performed and medication received by the patient will be taken from the medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OVATAR study patients | – | –Females with serous and endometrioid ovarian, peritoneal and fallopian tube cancer 18 years and older, diagnosed 3 months before enrolment into the study or later, consented to participate in this non-interventional study, who are being treated for OC, FTC (Fallopian Tube Cancer) and PC (Peritoneal Cancer) in the oncology hospitals/departments in the Russian Federation. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Females with serous and endometrioid ovarian, peritoneal and fallopian tube cancer 18 years and older, diagnosed 3 months before enrolment into the study or later, consented to participate in this non-interventional study, who are being treated for OC, FTC and PC in the oncology hospitals/departments in the Russian Federation.
Key inclusion criteria (3 listed)
- The voluntary obtained informed consent signed by both the subject and the investigator.
- Confirmed serous and endometrioid ovarian cancer or fallopian tube cancer or peritoneal cancer diagnosed 3 months before enrolment into the study or later
- Patients on treatment for OC (Ovarian Cancer) or FTC (Fallopian Tube Cancer) or PC (Peritoneal Cancer)
Key exclusion criteria (3 listed)
- The ovarian cancer histology other than serous and endometrioid.
- Patients participating in clinical studies.
- Any medical condition which on the opinion of the investigator may interfere the patient's participation in the trial.
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
Evaluation of 1st line chemotherapy treatment of serous and endometrioid ovarian, peritoneal and fallopian tube cancer (drugs by INN (International Nonproprietary Name), doses, regimen)
Time frame: up to 14 months
Evaluation of 1st line chemotherapy treatment of serous and endometrioid ovarian, peritoneal and fallopian tube cancer (drugs by INN, doses, regimen)
6 secondary outcomes
Data collection of patients characteristics (gender, age, race, co-morbidities, family history of ovarian and breast cancer)
Time frame: up to 14 months
Data collection of disease information (including genetic testing results)
Time frame: up to 14 months
Proportion of BRCAm+ among serous and endometrioid ovarian, peritoneal and fallopian tube cancer in Russia.
Time frame: up to 14 months
Evaluation of response to 1st line chemotherapy treatment of serous and endometrioid BRCAm+ ovarian, peritoneal and fallopian tube cancer
Time frame: up to 3 months
Assessment of relapses after 1st line of Pt (Platinum)-containing regimen for BRCAm+ patients
Time frame: up to 3 months
Evaluation of 2nd line chemotherapy treatment of serous and endometrioid ovarian, peritoneal and fallopian tube cancer (drugs by INN, doses, regimen) for BRCAm+ patients who have progressed after 1st line chemotherapy
Time frame: up to 3 months
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 21 May 2019.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Karin Otter study director
AstraZeneca
Vera Gorbunova principal investigator
Russian Cancer Research Center named after NN Blokhin
Alexandra Tyulandina principal investigator
Russian Cancer Research Center named after NN Blokhin
22 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, Peritoneal, Fallopian Tube Cancer, BRCAm+ in Russia, run by AstraZeneca at 22 sites in Russia.
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 3 inclusion and 3 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 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Russia. 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?
Evaluation of 1st line chemotherapy treatment of serous and endometrioid ovarian, peritoneal and fallopian tube cancer (drugs by INN (International Nonproprietary Name), doses, regimen) (time frame: up to 14 months). 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 21 May 2019.