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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03624712
Other study ID # ZGynO_DENOVA
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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