Clinical trial · Interventional
Evaluation of Pretreatment Sarcopenia in Patients With Inoperable High-grade Ovarian Carcinoma as Part of Optimised Management
NCT05415527CI-TRIAL-00101979OPTIMOVAcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
Prospective, monocentric study evaluating the presence of sarcopenia prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Presence of sarcopenia evaluated prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management(dietician and APA). | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- patients with inoperable high-grade ovarian carcinoma
- description
- Evaluation of sarcopenia in patients with inoperable high-grade ovarian carcinoma as part of optimised management
- interventionNames
- Other: Presence of sarcopenia evaluated prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management(dietician and APA).
Primary outcomes (1)
- measure
- Proportion of patients with pretreatment sarcopenia identified by analysis of the baseline CT-scan (CT0).
- timeFrame
- Baseline
- description
- Proportion of patients with pretreatment sarcopenia identified by analysis of the baseline CT-scan (CT0). According to the 2019 HAS guidelines \[Diagnosis of undernutrition in children and adults, November 2019\], we consider the patient to have sarcopenia if her MSI is strictly below 38.5 cm2/m2.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years. 2. Inoperable, high-grade, epithelial ovarian carcinoma requiring perioperative chemotherapy (neoadjuvant and adjuvant). 3. Optical medical treatment (carboplatin-taxol chemotherapy every 3 weeks) and surgery at Institut Bergonié. 4. Non-clinically undernourished patient, i.e. without loss of more than 10% bodyweight in 6 months 5. Free, informed and written consent signed by the participant and the investigator (on the day of inclusion at the latest and before any tests required for the research). 6. Patient with social security cover in accordance with Article 1121-11 of the French code of public health. Exclusion Criteria: 1. Contraindication to CT-scans. 2. Contraindication to bone mineral densitometry. 3. Patients over the age of 70 the G8 of whom requires oncogeriatric surgery. 4. Patients under guardianship, vulnerable patients or patients under any other legal protection measures. 5. Geographic, social or psychological factors meaning the patient is unable to commit to study follow-up and procedures. 6. Patient already included in this study or in another study evaluating the impact of sarcopenia.
References
Publications (0)
Data not yet available
No reference posted for this study.