Clinical Trials in Germany / NCT03624712
Recruiting
Observational
Analysis and Optimization of Predictive and Therapeutic Models in Uterine Neoplasms
NCT03624712 · tracked via the Priya Life Science Germany tracker
Condition(s) studied
Uterine Neoplasms
Investigational drug(s) / intervention(s)
uterine neoplasms
uterine 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
Study 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
Eligibility
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)
Primary outcome measure(s)
- 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 - CTC and DTC analysis — 12 months
Identification and quantification of genetic variants and mutations - 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
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| University Hospital Tuebingen, Department of Women's Health | Tübingen | Germany | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03624712 on ClinicalTrials.gov ↗ ← All trials in Germany