NCT05415527

Brief Summary

Prospective, monocentric study evaluating the presence of sarcopenia prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
25mo left

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Jun 2022Jun 2028

First Submitted

Initial submission to the registry

June 7, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

June 11, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2028

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

June 7, 2022

Last Update Submit

January 28, 2026

Conditions

Ovarian Carcinoma

Keywords

Inoperable high-grade ovarian carcinomaSarcopenia evaluationnutritional monitoringadapted physical activity

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with pretreatment sarcopenia identified by analysis of the baseline CT-scan (CT0).

    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.

    Baseline

Secondary Outcomes (1)

  • The time of access to chemotherapy

    From the date of surgery to the start date of adjuvant chemotherapy, assessed up to 2 months from surgery

Study Arms (1)

patients with inoperable high-grade ovarian carcinoma

OTHER

Evaluation of sarcopenia in patients with inoperable high-grade ovarian carcinoma as part of optimised management

Other: Presence of sarcopenia evaluated prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management(dietician and APA).

Interventions

Presence of sarcopenia evaluated prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management(dietician and APA).OTHER

Sarcopenia will be evaluated by CT-scan. This method will be combined with a bone mineral density test which is also a way of entering into a more specific approach to sarcopenia screening. The patients will receive optimised treatment by nutritional monitoring and adapted physical activity (APA) in addition to follow-up for sarcopenia.

patients with inoperable high-grade ovarian carcinoma

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Patient with social security cover in accordance with Article 1121-11 of the French code of public health.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Bergonié

Bordeaux, France

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Glutamyl Aminopeptidase

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

AminopeptidasesExopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloexopeptidasesMetalloproteases

Study Officials

  • Jean-Pierre GEKIERE, MD

    Institut Bergonié

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2022

First Posted

June 13, 2022

Study Start

June 11, 2022

Primary Completion (Estimated)

June 10, 2027

Study Completion (Estimated)

June 10, 2028

Last Updated

January 29, 2026

Record last verified: 2026-01

Locations

FR(1)