Germ Cell TumorVIVROVAIRE TRNCT03418844
Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy
A study testing Self-questionnaires of living conditions and quality of life and Cardiac, pulmonary, auditory and biological assessment in people with Germ Cell Tumor and Sex Cord Stromal Tumor, run by Centre Francois Baclesse at 19 sites in France.
Trial summary
While they are documented in patients in remission of testicular cancer, the sequelae of chemotherapy and the impact of the disease and its treatments on the living conditions and QoL of women in remission of rare ovarian cancer remain poorly explored. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Germ Cell Tumor, Sex Cord Stromal Tumor, Malignant Non-epithelial Ovarian Tumors
- What is being tested?
- Self-questionnaires of living conditions and quality of life and Cardiac, pulmonary, auditory and biological assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 19 sitesFrance
- Study dates
- 7 May 2018to Dec 2025
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age> 18 years;
- Patient with an ovarian malignant germ cell tumor (TGMO) or a stroma tumor and / or sex cords (TSCS) treated optimally;
- Patient who has had surgery and chemotherapy (interest group) or only a surgery (control group);
- Patient in remission more than 2 years after the end of the initial treatment;
- Relapse authorized if remission more than 2 years after the end of the treatment;
- Patient with no other cancers (with the exception of basal cell skin carcinomas, in situ cancers of the breast and cervix);
- Patient having signed his consent to participate
Who cannot join
- Pregnant or breastfeeding woman;
- Psychiatric pathology that may disrupt the course of the study or prevent the interpretation of results;
- Person deprived of liberty;
- Major subject to a legal protection measure or unable to express his consent.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites
Centre Paul Papin
Angers
CHU Besançon Jean MINJOZ
Besançon
Institut Bergonié
Bordeaux
CH Fleyriat
Bourg-en-Bresse
Centre François Baclesse
Caen
Centre Jean Perrin
Clermont-Ferrand
Centre Léon Berard
Lyon
Institut Paoli Calmettes
Marseille
Centre Catherine de Sienne
Nantes
Institut de Cancérologie de l'Ouest
Nantes
HEGP
Paris, Paris
GH Cochin Broca Hôtel-Dieu
Paris
Hôpital Diaconesses-Croix St Simon
Paris
Institut Curie,
Paris
Institut Gustave Roussy
Paris
CHU Poitiers
Poitiers
Institut Jean Godinot
Reims
Institut Rennais de Cancérologie
Rennes
CHRU Stasbourg Hôpital Civil
Strasbourg
About this study
While they are documented in patients in remission of testicular cancer, the sequelae of chemotherapy and the impact of the disease and its treatments on the living conditions and QoL of women in remission of rare ovarian cancer remain poorly explored.
The coordinator therefore propose a national 2-step case-control study to evaluate 1) chronic fatigue and QoL and 2) chemotherapy-related sequelae in adult patients in remission of surgery-treated TGMO or TSCS (conservative or not) supplemented with chemotherapy
- Being tested
- Self-questionnaires of living conditions and quality of life, Cardiac, pulmonary, auditory and biological assessment
- Medical subject headings
- Neoplasms, Germ Cell and Embryonal, Sex Cord-Gonadal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-questionnaires of living conditions and quality of lifeOther
Patients will complete self-questionnaires of living conditions and quality of life (MFI-20, FACT-G/FACT-O, FACT/COG-NTX, FACT-Cog, HADS, Insomnia Severity Index , International Physical Activity Questionnaire)
Cardiac, pulmonary, auditory and biological assessmentDiagnostic test
Patients will perform :
- Cardiac assesments (ECG, Carotid and humeral Doppler ultrasound, Trans-thoracic echocardiography 2D and 3D)
- Pulmonary and auditory assesment ( Respiratory Functional Exploration, Tonal audiogram)
- Blood tests
| Study group | Role | What they receive |
|---|---|---|
| Interest group (patients treated with chemotherapy) | Other | Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment Receives: Other: Self-questionnaires of living conditions and quality of life; Diagnostic Test: Cardiac, pulmonary, auditory and biological assessment |
| Patient control group (patients not treated with chemotherapy) | Other | Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment Receives: Other: Self-questionnaires of living conditions and quality of life; Diagnostic Test: Cardiac, pulmonary, auditory and biological assessment |
| Healthy volunteers | Other | Healthy volunteers will complete several self-questionnaires on living conditions and quality of life. Receives: Other: Self-questionnaires of living conditions and quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
The chronic fatigue by questionnaires
Measured: 2 years after surgery
The late sequelae of chemotherapy, particularly cardiovascular and pulmonary disorders, in adult patients in remission of a rare cancer of the ovary treated by surgery, supplemented or not by chemotherapy.
Measured: 2 years after surgery
The quality of life by questionnaires
Measured: 2 years after surgery
Secondary outcomes (4)
The fertility monitoring by questionnaires
Measured: 2 years after surgery
The symptoms of menopause by questionnaires
Measured: 2 years after surgery
Theimpact of cancer and its treatments on the trajectory and professional situation by questionnaires(access to work, professional ambition, financial situation ...);
Measured: 2 years after surgery
The parental projects by age (≤ 45 years) by questionnaires
Measured: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start7 May 2018
- Primary completion13 Jul 2021
- Study completionDec 2025 (estimated)
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 Germ Cell TumorStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Patients and healthy volunteers will complete several self-questionnaires on living conditions and quality of life. Patients will also perform a cardiac, pulmonary, auditory and biological assessment
- Masking
- None (open label)
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- ARCAGY/ GINECO GROUP
- Responsible party
- Sponsor
- Investigators
- Florence JOLY, Principal investigator, Centre François Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418844
- Sponsor's protocol ID
- VIVROVAIRE TR
- Acronym
- VIVROVAIRE TR
- Status last verified
- Aug 2025
- First submitted
- 15 Jan 2018
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dubot C, Ray-Coquard I, Lequesne J, Pautier P, Renaud T, Selle F, Berton-Rigaud D, Frank S, De La Motte Rouge T, Kalbacher E, Provansal M, Blonz C, Orfeuvre H, Alexandre J, Augereau P, Nadeau C, Kurtz JE, Hanvic B, Fresneau B, Ahmed-Lecheheb D, Christy F, Grellard JM, Clarisse B, Gernier F, Joly F. Long-term quality of life in non-epithelial ovarian cancer survivors: TMRG-GINECO-Vivrovaire rare tumors case-control study. BMC Med. 2025 Dec 12;24(1):34. doi: 10.1186/s12916-025-04540-x.
PubMed 41382138
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy
- ClinicalTrials.gov ID
- NCT03418844
- Acronym / sponsor ID
- VIVROVAIRE TR / VIVROVAIRE TR
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- ARCAGY/ GINECO GROUP
- Study start
- 7 May 2018 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Feb 2018 (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.
While they are documented in patients in remission of testicular cancer, the sequelae of chemotherapy and the impact of the disease and its treatments on the living conditions and QoL of women in remission of rare ovarian cancer remain poorly explored.
The coordinator therefore propose a national 2-step case-control study to evaluate 1) chronic fatigue and QoL and 2) chemotherapy-related sequelae in adult patients in remission of surgery-treated TGMO or TSCS (conservative or not) supplemented with chemotherapy
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients and healthy volunteers will complete several self-questionnaires on living conditions and quality of life. Patients will also perform a cardiac, pulmonary, auditory and biological assessment
| Arm | Type | Receives |
|---|---|---|
| Interest group (patients treated with chemotherapy) | Other | Other: Self-questionnaires of living conditions and quality of life, Diagnostic Test: Cardiac, pulmonary, auditory and biological assessmentPatients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment |
| Patient control group (patients not treated with chemotherapy) | Other | Other: Self-questionnaires of living conditions and quality of life, Diagnostic Test: Cardiac, pulmonary, auditory and biological assessmentPatients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment |
| Healthy volunteers | Other | Other: Self-questionnaires of living conditions and quality of lifeHealthy volunteers will complete several self-questionnaires on living conditions and quality of life. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age> 18 years;
- Patient with an ovarian malignant germ cell tumor (TGMO) or a stroma tumor and / or sex cords (TSCS) treated optimally;
- Patient who has had surgery and chemotherapy (interest group) or only a surgery (control group);
- Patient in remission more than 2 years after the end of the initial treatment;
- Relapse authorized if remission more than 2 years after the end of the treatment;
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding woman;
- Psychiatric pathology that may disrupt the course of the study or prevent the interpretation of results;
- Person deprived of liberty;
- Major subject to a legal protection measure or unable to express his consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-questionnaires of living conditions and quality of lifePatients will complete self-questionnaires of living conditions and quality of life (MFI-20, FACT-G/FACT-O, FACT/COG-NTX, FACT-Cog, HADS, Insomnia Severity Index , International Physical Activity Questionnaire) | Other | Healthy volunteers, Interest group (patients treated with chemotherapy), Patient control group (patients not treated with chemotherapy) |
| Cardiac, pulmonary, auditory and biological assessmentPatients will perform : * Cardiac assesments (ECG, Carotid and humeral Doppler ultrasound, Trans-thoracic echocardiography 2D and 3D) * Pulmonary and auditory assesment ( Respiratory Functional Exploration, Tonal audiogram) * Blood tests | Diagnostic test | Interest group (patients treated with chemotherapy), Patient control group (patients not treated with chemotherapy) |
Primary outcome
The chronic fatigue by questionnaires
Time frame: 2 years after surgery
The late sequelae of chemotherapy, particularly cardiovascular and pulmonary disorders, in adult patients in remission of a rare cancer of the ovary treated by surgery, supplemented or not by chemotherapy.
Time frame: 2 years after surgery
The quality of life by questionnaires
Time frame: 2 years after surgery
4 secondary outcomes
The fertility monitoring by questionnaires
Time frame: 2 years after surgery
The symptoms of menopause by questionnaires
Time frame: 2 years after surgery
Theimpact of cancer and its treatments on the trajectory and professional situation by questionnaires(access to work, professional ambition, financial situation ...);
Time frame: 2 years after surgery
The parental projects by age (≤ 45 years) by questionnaires
Time frame: 2 years after surgery
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 22 Sep 2025.
- Derived from this study: PubMed 41382138Dubot C, Ray-Coquard I, Lequesne J, Pautier P, Renaud T, Selle F, Berton-Rigaud D, Frank S, De La Motte Rouge T, Kalbacher E, Provansal M, Blonz C, Orfeuvre H, Alexandre J, Augereau P, Nadeau C, Kurtz JE, Hanvic B, Fresneau B, Ahmed-Lecheheb D, Christy F, Grellard JM, Clarisse B, Gernier F, Joly F. Long-term quality of life in non-epithelial ovarian cancer survivors: TMRG-GINECO-Vivrovaire rare tumors case-control study. BMC Med. 2025 Dec 12;24(1):34. doi: 10.1186/s12916-025-04540-x.
- 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.
Florence JOLY principal investigator
Centre François Baclesse
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-questionnaires of living conditions and quality of life and Cardiac, pulmonary, auditory and biological assessment in people with Germ Cell Tumor and Sex Cord Stromal Tumor, run by Centre Francois Baclesse at 19 sites in France.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. 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?
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?
The chronic fatigue by questionnaires (time frame: 2 years after surgery). The study lists 3 primary outcomes in all. 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 NCT03418844, 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 22 Sep 2025.