Analysis and Optimization of Predictive and Therapeutic Models in Uterine Neoplasms

Uterine Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03624712
• Other study ID #: ZGynO_DENOVA
• Status: Recruiting
• Start date: January 2012
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 580
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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)

Related Conditions & MeSH terms

• Neoplasms
• Uterine Neoplasms

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital Tuebingen, Department of Women's Health	Tuebingen

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital Tuebingen	University Hospital Freiburg, University Hospital Heidelberg, University of Homburg

Country where clinical trial is conducted

Germany, 

Outcome

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