ClinicalTrials.gg
Sign In
Active, not recruitingNCT03418844VIVROVAIRE TRUpdated Sep 22, 2025

Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy

An interventional study of Self-questionnaires of living conditions and quality of life and Cardiac, pulmonary, auditory and biological assessment in Germ Cell Tumor, Sex Cord Stromal Tumor and Malignant Non-epithelial Ovarian Tumors, sponsored by Centre Francois Baclesse. Active, not recruiting at 19 sites in France. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-22.

Sponsored by Centre Francois Baclesse · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
268
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

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

02

Conditions studied

  • Germ Cell Tumor
  • Sex Cord Stromal Tumor
  • Malignant Non-epithelial Ovarian Tumors
03

In context

Neoplasms, Germ Cell and Embryonal

166 studies on the registry are indexed under Neoplasms, Germ Cell and Embryonal; 48 are open to participants now.

This study's planned enrollment of 268 is above the median of 36 across 124 interventional studies indexed under Neoplasms, Germ Cell and Embryonal.

Browse Neoplasms, Germ Cell and Embryonal studies →

Lead sponsor

Centre Francois Baclesse is the lead sponsor of 110 studies on the registry; 26 are open to participants now.

Browse Centre Francois Baclesse studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
268 participants (estimated)

Study arms

  • Other
    Interest group (patients treated with chemotherapy)

    Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment

    Other: Self-questionnaires of living conditions and quality of life · Diagnostic Test: Cardiac, pulmonary, auditory and biological assessment

  • Other
    Patient control group (patients not treated with chemotherapy)

    Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment

    Other: Self-questionnaires of living conditions and quality of life · Diagnostic Test: Cardiac, pulmonary, auditory and biological assessment

  • Other
    Healthy volunteers

    Healthy volunteers will complete several self-questionnaires on living conditions and quality of life.

    Other: Self-questionnaires of living conditions and quality of life

Interventions

  • OtherSelf-questionnaires of living conditions and quality of life

    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)

  • Diagnostic testCardiac, pulmonary, auditory and biological assessment

    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

06

What researchers measure

Primary outcomes

  1. The chronic fatigue by questionnaires

    Time frame: 2 years after surgery

  2. 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

  3. The quality of life by questionnaires

    Time frame: 2 years after surgery

Secondary outcomes

  1. The fertility monitoring by questionnaires

    Time frame: 2 years after surgery

  2. The symptoms of menopause by questionnaires

    Time frame: 2 years after surgery

  3. 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

  4. The parental projects by age (≤ 45 years) by questionnaires

    Time frame: 2 years after surgery

07

Study locations

19 sites
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2018 to primary completion in Jul 2021, 38 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 15, 2018
First posted
Feb 1, 2018
StartActual
May 7, 2018
Primary completionActual
Jul 13, 2021
CompletionEst.
Dec 2025
Last update
Sep 22, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03418844
Lead sponsor
Centre Francois Baclesse
Collaborators
ARCAGY/ GINECO GROUP
Responsible party
Sponsor
First posted
Feb 1, 2018
Start date
May 7, 2018
Primary completion
Jul 13, 2021
Completion
Dec 2025 (estimated)
Last update
Sep 22, 2025

Study contacts

Florence JOLY
principal investigator · Centre François Baclesse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neoplasms, Germ Cell and Embryonal →

Other studies from this sponsor

Centre Francois Baclesse →

Start the discussion