Ovarian CancerEORTC QLQ-OV39NCT07465133
Updating the EORTC Quality-of-Life Questionnaire for Ovarian Cancer (QLQ-OV38)
An observational study of Ovarian Cancer and Quality of Life, run by Helios University Hospital Wuppertal at 1 site in Germany.
Trial summary
The goal of this observational study is to pre-test the EORTC QLQ-OV39 to identify and resolve potential problems in its administration and to identify missing/redundant items. A preliminary evaluation of the measurement properties of the module will be carried out. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Quality of Life
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Ovarian cancer patients from collaborating centers
Who may be able to join
- Evidence of localized (FIGO I-II) or advanced ovarian cancer (FIGO II-IV)
- Must be able and willing to complete the questionnaires.
- Must be able to understand and speak the language in which the patient will complete the questionnaire.
- Age > 18 years
Who cannot join
- cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Helios University Clinic Wuppertal, University Witten/Herdecke
Wuppertal, North Rhine-Westphalia, 42283
Vesna Bjelic-Radisic, Prof, +492028961411, vesna.bjelic-radisic@helios-gesundheit.de
Jennifer C. Steinmetz, +49 202 896 1478, jennifer.steinmetz2@helios-gesundheit.de
About this study
Official title: The Update of the EORTC QLQ-Ovarial Cancer Module (EORTC-QLQ-OV28) - OV39 Phase III
The goal of this observational study is to pre-test the EORTC QLQ-OV39 to identify and resolve potential problems in its administration and to identify missing/redundant items. A preliminary evaluation of the measurement properties of the module will be carried out.
The study includes patients with evidence of localized (FIGO I-II) or advanced ovarian cancer (FIGO II-IV) above the age of 18 years.
Read more
The main aims are:
- To conduct Phase 3a and 3b pre-testing of the preliminary EORTC-QLQ-OV39 Questionnaire to identify and resolve potential problems in its administration and to identify missing/redundant items according to the updated EORTC QLG Guidelines for Module Development, 5th Edition 2021.(16)
- a preliminary assessment of the psychometric properties of the module
Participants will [describe the main tasks participants will be asked to, complete the OV39, C30 and debriefing interviews, as well as questions about their demographics and clinical data.
Read the detailed description
Follows.
- Conditions
- Ovarian Cancer, Quality of Life
- Keywords
- ovarian cancer, EORTC, Quality of Life, EORTC Quality of life group
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire
Questionnaire for the quality of life of ovarian cancer patients. Patients are advised to indicate on a 4-point-Likert scale (1 = not at all; 2 = a little; 3 = quite a bit; 4 = very much) how much a specific issue has occured within a specific time frame and how much this had had an impact on them. Higher scored meaning more impact on quality of life.
Measured: Last week or last four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helios University Hospital Wuppertal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vesna Bjelic-Radisic, Helios University Hospital Wuppertal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465133
- Sponsor's protocol ID
- OV28 Phase III
- Acronym
- EORTC QLQ-OV39
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not publicly available due to privacy restrictions and ethical considerations
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Update of the EORTC QLQ-Ovarial Cancer Module (EORTC-QLQ-OV28) - OV39 Phase III
- ClinicalTrials.gov ID
- NCT07465133
- Acronym / sponsor ID
- EORTC QLQ-OV39 / OV28 Phase III
- Conditions
- Ovarian Cancer, Quality of Life
- Keywords
- ovarian cancer, EORTC, Quality of Life, EORTC Quality of life group
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Helios University Hospital WuppertalUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Mar 2026 (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.
The goal of this observational study is to pre-test the EORTC QLQ-OV39 to identify and resolve potential problems in its administration and to identify missing/redundant items. A preliminary evaluation of the measurement properties of the module will be carried out.
The study includes patients with evidence of localized (FIGO I-II) or advanced ovarian cancer (FIGO II-IV) above the age of 18 years.
The main aims are:
- To conduct Phase 3a and 3b pre-testing of the preliminary EORTC-QLQ-OV39 Questionnaire to identify and resolve potential problems in its administration and to identify missing/redundant items according to the updated EORTC QLG Guidelines for Module Development, 5th Edition 2021.(16)
- a preliminary assessment of the psychometric properties of the module
Participants will [describe the main tasks participants will be asked to, complete the OV39, C30 and debriefing interviews, as well as questions about their demographics and clinical data.
Detailed description
Follows.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ovarian cancer patients from collaborating centers
Key inclusion criteria (4 listed)
- Evidence of localized (FIGO I-II) or advanced ovarian cancer (FIGO II-IV)
- Must be able and willing to complete the questionnaires.
- Must be able to understand and speak the language in which the patient will complete the questionnaire.
- Age > 18 years
Key exclusion criteria (1 listed)
- cognitive impairment
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
Questionnaire
Time frame: Last week or last four weeks
Questionnaire for the quality of life of ovarian cancer patients. Patients are advised to indicate on a 4-point-Likert scale (1 = not at all; 2 = a little; 3 = quite a bit; 4 = very much) how much a specific issue has occured within a specific time frame and how much this had had an impact on them. Higher scored meaning more impact on quality of life.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data are not publicly available due to privacy restrictions and ethical considerations
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
Helios University Clinic Wuppertal, University Witten/Herdecke
Wuppertal, Germany
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 and Quality of Life, run by Helios University Hospital Wuppertal at 1 site 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 4 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: opening soon, as of the sponsor's last update on 18 Sep 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire (time frame: Last week or last four weeks). 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 18 Sep 2026.