Recruiting NCT03624712
Analysis and Optimization of Predictive and Therapeutic Models in Uterine Neoplasms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: uterine neoplasms.
- Who it may be relevant to
- Registry conditions: Uterine Neoplasms. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective, Tricentric Open Trial on the Analysis and Optimization of Predictive and Therapeutic Models in Uterine Neoplasms
Overview
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 test 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
Primary outcome measures
- CTC and DTC analysis [Time frame: 12 months]
- HPV [Time frame: 12 months]
- DNA [Time frame: 12 months]
- Douglas cytology [Time frame: 12 months]
- Proteomic analysis [Time frame: 12 months]
- Sentinel lymph nodes [Time frame: 12 months]
- Peripheral nerve conduction velocity [Time frame: 12 months]
- Urodynamic- cystomanometry between pre an post radical gynecological surgeryuroflowmetry [Time frame: 12 months]
- CTC and DTC analysis [Time frame: 12 months]
- Urodynamic- urethral pressure profile between pre an post radical gynecological surgeryuroflowmetry [Time frame: 12 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Germany · 1 center
- University Hospital Tuebingen, Department of Women's Health — Tübingen
Identifiers
NCT: NCT03624712 · ZGynO_DENOVA