Clinical trial · Interventional
Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy
NCT03418844CI-TRIAL-00095583VIVROVAIRE TRactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Germ Cell Tumor | Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
| Malignant Non-epithelial Ovarian Tumors | — | UNRESOLVED | — |
| Sex Cord Stromal Tumor | Sex Cord-Stromal Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiac, pulmonary, auditory and biological assessment | Diagnostic Test | — | UNRESOLVED |
| Self-questionnaires of living conditions and quality of life | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Interest group (patients treated with chemotherapy)
- description
- Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment
- interventionNames
- Other: Self-questionnaires of living conditions and quality of life
- Diagnostic Test: Cardiac, pulmonary, auditory and biological assessment
- type
- OTHER
- label
- Patient control group (patients not treated with chemotherapy)
- description
- Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment
- interventionNames
- Other: Self-questionnaires of living conditions and quality of life
- Diagnostic Test: Cardiac, pulmonary, auditory and biological assessment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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: * 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.
References
Publications (1)
- DERIVEDDubot 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. PMID 41382138