Analysis and Optimization of Predictive and Therapeutic Models in Uterine Neoplasms

Study Overview
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Brief Summary
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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

Official Title
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Prospective, Tricentric Open Trial on the Analysis and Optimization of Predictive and Therapeutic Models in Uterine Neoplasms

Conditions
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Uterine Neoplasms

Intervention / Treatment
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* Diagnostic Test: uterine neoplasms


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| uterine neoplasms<br>Women with operable and inoperable uterine malignomas (cervical cancer, endometrial cancer, uterine sarcoma) | Diagnostic Test: uterine neoplasms<br>* Analysis of circulating (CTC) and disseminating tumor cells (DTC), determination of Human Papilloma Virus (HPV), Douglas cytology, DNA analysis in blood, proteome analysis, sentinel lymph node detection<br>|

What is the study measuring?
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Primary Outcome Measures

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