Status:
RECRUITING
Evaluation of Pretreatment Sarcopenia in Patients With Inoperable High-grade Ovarian Carcinoma as Part of Optimised Management
Lead Sponsor:
Institut Bergonié
Conditions:
Ovarian Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Prospective, monocentric study evaluating the presence of sarcopenia prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management.
Detailed Description
Prior to carrying out the research, the informed consent of the person must be obtained after being informed of the purpose of the research, its conduct and duration, benefits, potential risks and con...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Inoperable, high-grade, epithelial ovarian carcinoma requiring perioperative chemotherapy (neoadjuvant and adjuvant).
- Optical medical treatment (carboplatin-taxol chemotherapy every 3 weeks) and surgery at Institut Bergonié.
- Non-clinically undernourished patient, i.e. without loss of more than 10% bodyweight in 6 months
- 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).
- Patient with social security cover in accordance with Article 1121-11 of the French code of public health.
Exclusion
- Contraindication to CT-scans.
- Contraindication to bone mineral densitometry.
- Patients over the age of 70 the G8 of whom requires oncogeriatric surgery.
- Patients under guardianship, vulnerable patients or patients under any other legal protection measures.
- Geographic, social or psychological factors meaning the patient is unable to commit to study follow-up and procedures.
- Patient already included in this study or in another study evaluating the impact of sarcopenia.
Key Trial Info
Start Date :
June 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05415527
Start Date
June 11 2022
End Date
January 1 2028
Last Update
November 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institut Bergonié
Bordeaux, France