Analysis and Optimization of Predictive and Therapeutic Models in Uterine Neoplasms

Recruiting

• Conditions: Uterine Neoplasms
• Interventions: Diagnostic Test: uterine neoplasms

• Registration Number: NCT03624712
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

Evaluation of clinical, therapeutic and prognostic relevance of new experimental results as well as optimization of therapeutic models and development of a new algorithm for therapeutic plan and therapy in patients with uterine neoplasm

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2018-07-04
• Study First Submitted QC: 2018-08-06
• Study First Posted: 2018-08-10
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 580

Inclusion Criteria

• Confirmed uterine malignancy ( cervical cancer, endometrial cancer, sarcoma)
• If operable: surgical primary therapy: laparoscopic/robot-assisted or open radical gyneco-oncological surgery
• Written consent
• Willingness and ability to participate in all study-specific procedures
• Age ≥ 18 years

Exclusion Criteria

• Severe and acute general disease in the last 4 weeks
• Acute or chronic psychiatric disorders
• Other factors questioning study participation (e.g. acute psychosocial stress, insufficient understanding of nature and consequences of the study, inadequate skills of the German language)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
uterine neoplasms	uterine neoplasms	Women with operable and inoperable uterine malignomas (cervical cancer, endometrial cancer, uterine sarcoma)

Primary Outcome Measures

Name	Time	Method
CTC and DTC analysis	12 months	Identification and quantification of genetic variants and mutations
HPV	12 months	Analysis of HPV types by DNA tests in peripheral blood, bone marrow, sentinel-lymph node, cervical-, endometrial- and myometrial-tissue, intraperitoneal wash fluid
Sentinel lymph nodes	12 months	Number of detectable lymph nodes by Tc99m- and indocyanine green-labeling
Urodynamic- cystomanometry between pre an post radical gynecological surgeryuroflowmetry	12 months	pressur/volume relationship
Urodynamic- uroflowmetry between pre an post radical gynecological surgeryuroflowmetry	12 months	rate of flow of urine
Douglas cytology	12 months	Intraperitoneal wash fluid
Proteomic analysis	12 months	Analysis of proteins by mass spectrometry in removed uterine and sentinel lymph node tissue
Peripheral nerve conduction velocity	12 months	Intra- and interindividual comparison of N. obturatorius, N. pudendus between pre an post radical gynecological surgery
Urodynamic- urethral pressure profile between pre an post radical gynecological surgeryuroflowmetry	12 months	cm H20
DNA	12 months	Determination of DNA in peripheral blood

Trial Locations

Locations (1)

University Hospital Tuebingen, Department of Women's Health; 🇩🇪 Tuebingen, Germany