Uterine Neoplasms
Conditions
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
Interventions
DIAGNOSTIC_TESTuterine neoplasms
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
Sponsors
University Hospital Heidelberg
University of Homburg
University Hospital Freiburg
University Hospital Tuebingen
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CTC and DTC analysis | 12 months | Counting the number of tumor cells in blood and bone marrow |
| 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 |
| DNA | 12 months | Determination of DNA in peripheral blood |
| 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 |
| Sentinel lymph nodes | 12 months | Number of detectable lymph nodes by Tc99m- and indocyanine green-labeling |
| Peripheral nerve conduction velocity | 12 months | Intra- and interindividual comparison of N. obturatorius, N. pudendus between pre an post radical gynecological surgery |
| Urodynamic- cystomanometry between pre an post radical gynecological surgeryuroflowmetry | 12 months | pressur/volume relationship |
| Urodynamic- urethral pressure profile between pre an post radical gynecological surgeryuroflowmetry | 12 months | cm H20 |
| Urodynamic- uroflowmetry between pre an post radical gynecological surgeryuroflowmetry | 12 months | rate of flow of urine |
Countries
Germany
Outcome results
None listed