Ovarian Cancer, Hereditary Ovarian Cancer SyndromeC-PATROLNCT02503436
C-PATROL - Non-interventional Study (NIS) to Collect Clinical and Patient Reported Outcome Data in an Olaparib Treated BRCAm+ PSR Ovarian Cancer Population
An observational study of Ovarian Cancer, Hereditary Ovarian Cancer Syndrome, run by AstraZeneca at 68 sites in Germany.
Trial summary
The main objective of the proposed non-interventional study is to obtain real-world effectiveness, safety and treatment patterns data of patients with BRCAm+ (Breast Cancer Gene(s) mutation positive) platinum sensitive relapsed (PSR) ovarian cancer in German hospitals and outpatient practices treated with olaparib. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Hereditary Ovarian Cancer Syndrome
- How many people
- 276 participants
- Where
- 68 sitesGermany
- Study dates
- 28 Oct 2015to 1 Dec 2022
- How long will I take part?
- 84 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 300 patients in 80 sites (approx. 40 hospitals and 40 outpatient practices) in Germany. Each site should enrol 2-30 patients
Who may be able to join
- Signed written informed consent
- Women aged ≥ 18 years
- Patients with platinum sensitive relapsed high grade epithelial ovarian cancers (including primary peritoneal and/or fallopian tube cancer). (Platinum sensitive disease is defined as disease progression ≥6 months after completion of their last dose of platinum based chemotherapy. Patients must be currently in response to platinum-based chemotherapy. For the last chemotherapy course immediately prior to enrolment on the study, patients must be, in the opinion of the investigator, in response (partial or complete), following completion of this chemotherapy course.
- Documented BRCA mutations (germline and/or somatic mutation in BRCA1 (Breast Cancer gene 1) and/or BRCA2 (Breast Cancer gene 2) that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function))
- Patients should be in line with the specifications mentioned in the German LYNPARZA (olaparib) SmPC (Summary Product Characteristics) for hard capsules or tablets.
- Patients are able to read and understand German, English, Turkish or Arabic
Who cannot join
- Known hypersensitivity to olaparib or any of the excipients of the drug
- Patients who have started olaparib monotherapy for more than 14 days before giving their informed consent
- Pregnancy or breast feeding
Trial locations and contacts
68 sites in 1 country.
68 sites in 1 country
Germany68 sites
Research Site
Amberg
Research Site
Aschaffenburg
Research Site
Augsburg
Research Site
Bad Homburg
Research Site
Berlin
Research Site
Bonn
Research Site
Bottrop
Research Site
Brandenburg an der Havel
Research Site
Braunschweig
Research Site
Bremen
Research Site
Chemnitz
Research Site
Coburg
Research Site
Cologne
Research Site
Donauwörth
Research Site
Dortmund
Research Site
Dresden
Research Site
Duisburg
Research Site
Düsseldorf
Research Site
Erlangen
Research Site
Essen
Research Site
Esslingen am Neckar
Research Site
Eutin
Research Site
Frankfurt
Research Site
Freiburg im Breisgau
Research Site
Fürstenwalde
Research Site
Georgsmarienhütte
Research Site
Halle
Research Site
Hamburg
Research Site
Hanover
Research Site
Heidelberg
Research Site
Heidenheim
Research Site
Hildesheim
Research Site
Homburg/Saar
Research Site
Jena
Research Site
Karlsruhe
Research Site
Kassel
Research Site
Kempten
Research Site
Kiel
Research Site
Krefeld
Research Site
Kulmbach
Research Site
Landshut
Research Site
Lübeck
Research Site
Mainz
Research Site
Mannheim
Research Site
Mönchengladbach
Research Site
München
Research Site
Münster
Research Site
Mutlangen
Research Site
Nuremberg
Research Site
Oberhausen
Research Site
Osnabrück
Research Site
Paderborn
Research Site
Plauen
Research Site
Regensburg
Research Site
Rosenheim
Research Site
Rostock
Research Site
Saarbrücken
Research Site
Schwerin
Research Site
Singen
Research Site
Solingen
Research Site
Stralsund
Research Site
Stuttgart
Research Site
Traunstein
Research Site
Troisdorf
Research Site
Tübingen
Research Site
Wiesbaden
Research Site
Wolfsburg
Research Site
Würzburg
About this study
Official title: C-PATROL - a Single Arm, Prospective Non-interventional Study (NIS) to Collect Clinical and Patient Reported Outcome Data in an Olaparib Treated BRCAm+ PSR Ovarian Cancer Population
The main objective of the proposed non-interventional study is to obtain real-world effectiveness, safety and treatment patterns data of patients with BRCAm+ (Breast Cancer Gene(s) mutation positive) platinum sensitive relapsed (PSR) ovarian cancer in German hospitals and outpatient practices treated with olaparib.
- Keywords
- Ovarian Cancer, Fallopian Tube Cancer, primary peritoneal cancer, BRCA1 Gene, BRCA2 Gene
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Fanconi Anemia, Complementation Group D1
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess clinical effectiveness of olaparib maintenance monotherapy by assessment of progression free survival (PFS) in patients with BRCAm+ ovarian cancer. Methods and time intervals for tumor assessment depend on the investigator's decision.
Measured: Date of first documented dose of olaparib to the date of progression (as judged by the investigator) or death (of any cause) whichever occurred before, assessed approximately up to 84 months
Secondary outcomes (7)
To collect and explore real-life data on patient outcomes in terms of Overall Survival (OS)
Measured: Date of first documented dose of olaparib to death of any cause, assessed approximately up to 84 months
Time to first subsequent therapy (TFST)
Measured: Date of first documented dose of olaparib to date of first administration of first subsequent therapy or death if this occurs before commencement of first subsequent treatment, assessed approximately up to 84 months
Progression-free survival 2 (PFS2)
Measured: Date of first administration of first subsequent therapy to date of progression as assessed by the investigator or death, assessed approximately up to 84 months
Time to second subsequent therapy (TSST)
Measured: Date of first documented dose of olaparib to date of first administration of second subsequent therapy or death if this occurs before commencement of second subsequent treatment, assessed approximately up to 84 months
Time to discontinuation of olaparib monotherapy (TDO)
Measured: Date of first documented dose of olaparib montherapy to date of last documented dose of olaparib monotherapy or death whichever occurred before, assessed approximately up to 84 months
Assessment of health-related quality of life (HRQoL) in patients participating in the study.
Health related quality of life (HRQoL): Assessment of general cancer-associated and specific ovarian cancer associated parameters by use of standardized HRQoL questionnaires:
- Functional assessment of Cancer Therapy for Patients with Ovarian Cancer (FACT-O)
- Functional Assessment of Chronic Illness - Fatigue (FACIT-Fatigue)
- Functional Living Index - Emesis (FLIE)
Measured: Date of first visit to last visit. HRQoL are collected every 3 months up to 84 months
Safety of Olaparib: collection of Adverse Events (AE)
Type and frequeny of adverse event (AE), intensity, causal relationship to olaparib, outcome, seriousness, management of adverse event
Measured: Date of first documented dose of Olaparib to last visit, assessed approximately up to 84 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study start28 Oct 2015
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cancer, Hereditary Ovarian Cancer SyndromeStudies 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
- 276 participants (actual)
- Target duration
- 84 Months
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503436
- Sponsor's protocol ID
- D0816R00009
- Acronym
- C-PATROL
- Status last verified
- Nov 2023
- First submitted
- 8 Jul 2015
- Last updated
- 4 Dec 2023
- 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 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C-PATROL - a Single Arm, Prospective Non-interventional Study (NIS) to Collect Clinical and Patient Reported Outcome Data in an Olaparib Treated BRCAm+ PSR Ovarian Cancer Population
- ClinicalTrials.gov ID
- NCT02503436
- Acronym / sponsor ID
- C-PATROL / D0816R00009
- Keywords
- Ovarian Cancer, Fallopian Tube Cancer, primary peritoneal cancer, BRCA1 Gene, BRCA2 Gene
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2015 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 21 Jul 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.
The main objective of the proposed non-interventional study is to obtain real-world effectiveness, safety and treatment patterns data of patients with BRCAm+ (Breast Cancer Gene(s) mutation positive) platinum sensitive relapsed (PSR) ovarian cancer in German hospitals and outpatient practices treated with olaparib.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 84 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300 patients in 80 sites (approx. 40 hospitals and 40 outpatient practices) in Germany. Each site should enrol 2-30 patients
Key inclusion criteria (6 listed)
- Signed written informed consent
- Women aged ≥ 18 years
- Patients with platinum sensitive relapsed high grade epithelial ovarian cancers (including primary peritoneal and/or fallopian tube cancer). (Platinum sensitive disease is defined as disease progression ≥6 months after completion of their last dose of platinum based chemotherapy. Patients must be currently in response to platinum-based chemotherapy. For the last chemotherapy course immediately prior to enrolment on the study, patients must be, in the opinion of the investigator, in response (partial or complete), following completion of this chemotherapy course.
- Documented BRCA mutations (germline and/or somatic mutation in BRCA1 (Breast Cancer gene 1) and/or BRCA2 (Breast Cancer gene 2) that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function))
- Patients should be in line with the specifications mentioned in the German LYNPARZA (olaparib) SmPC (Summary Product Characteristics) for hard capsules or tablets.
Key exclusion criteria (3 listed)
- Known hypersensitivity to olaparib or any of the excipients of the drug
- Patients who have started olaparib monotherapy for more than 14 days before giving their informed consent
- Pregnancy or breast feeding
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
To assess clinical effectiveness of olaparib maintenance monotherapy by assessment of progression free survival (PFS) in patients with BRCAm+ ovarian cancer. Methods and time intervals for tumor assessment depend on the investigator's decision.
Time frame: Date of first documented dose of olaparib to the date of progression (as judged by the investigator) or death (of any cause) whichever occurred before, assessed approximately up to 84 months
7 secondary outcomes
To collect and explore real-life data on patient outcomes in terms of Overall Survival (OS)
Time frame: Date of first documented dose of olaparib to death of any cause, assessed approximately up to 84 months
Time to first subsequent therapy (TFST)
Time frame: Date of first documented dose of olaparib to date of first administration of first subsequent therapy or death if this occurs before commencement of first subsequent treatment, assessed approximately up to 84 months
Progression-free survival 2 (PFS2)
Time frame: Date of first administration of first subsequent therapy to date of progression as assessed by the investigator or death, assessed approximately up to 84 months
Time to second subsequent therapy (TSST)
Time frame: Date of first documented dose of olaparib to date of first administration of second subsequent therapy or death if this occurs before commencement of second subsequent treatment, assessed approximately up to 84 months
Time to discontinuation of olaparib monotherapy (TDO)
Time frame: Date of first documented dose of olaparib montherapy to date of last documented dose of olaparib monotherapy or death whichever occurred before, assessed approximately up to 84 months
Assessment of health-related quality of life (HRQoL) in patients participating in the study.
Time frame: Date of first visit to last visit. HRQoL are collected every 3 months up to 84 months
Safety of Olaparib: collection of Adverse Events (AE)
Time frame: Date of first documented dose of Olaparib to last visit, assessed approximately up to 84 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 4 Dec 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
68 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 Cancer, Hereditary Ovarian Cancer Syndrome, run by AstraZeneca at 68 sites in Germany.
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 6 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 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in Germany. 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?
To assess clinical effectiveness of olaparib maintenance monotherapy by assessment of progression free survival (PFS) in patients with BRCAm+ ovarian cancer. Methods and time intervals for tumor assessment depend on the investigator's decision. (time frame: Date of first documented dose of olaparib to the date of progression (as judged by the investigator) or death (of any cause) whichever occurred before, assessed approximately up to 84 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 4 Dec 2023.