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Frail-B: Prospective, non-interventional cohort study investigating frailty in gynecologic oncology patients

Frail-B: Prospective, non-interventional cohort study investigating frailty in gynecologic oncology patients - Frail-B

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00032361
Enrollment
500
Registered
2023-08-04
Start date
2023-02-06
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty gynecologic oncology

Interventions

Group 1: Adult female patients (age = 60 years and/or BMI (Body Mass Index) = 35kg/m² and/or subjectively frail) with a confirmed diagnosis of a gynecological tumor, regardless of the clinical stage,

Sponsors

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Abteilung Klinik und Poliklinik für Geburtshilfe und Frauengesundheit
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Adult female patients (age = 60 years and/or BMI (Body Mass Index) = 35kg/m² and/or subjectively frail) with a confirmed diagnosis of a gynecological tumor, regardless of the clinical stage, treatment type, and treatment line, who require stage-appropriate surgical therapy.

Exclusion criteria

Exclusion criteria: - Lack of histological confirmation - Benign pathology - Missing informed consent

Design outcomes

Primary

MeasureTime frame
Correlation of frailty status with postoperative complications in patients with gynecological tumors

Secondary

MeasureTime frame
- progression-free survival (PFS), disease specific survival (DSS) and overall survival (OS) and correlation with the preoperative screening tools - length of hosptial stay and readmission rate - Influence of the comprehensive geriatric assessment on the outcome of the frail cohort - collection of preoperative risk factors - correlation of screening tests, laboratory results and clinical parameters with PFS, DSS and OS - screening of potential biomarkers for frailty in serum and saliva

Countries

Germany

Contacts

Public ContactValerie Linz

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Abteilung Klinik und Poliklinik für Geburtshilfe und Frauengesundheit

valerie.linz@unimedizin-mainz.de+49 6131 170

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026