Analysis and Optimization of Predictive and Therapeutic Models in Uterine Neoplasms

University Hospital Tuebingen580 enrolled

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

Study Type

OBSERVATIONAL

Enrollment

580

Conditions

Uterine Neoplasms

Interventions

uterine neoplasmsDIAGNOSTIC_TEST

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University Hospital Tuebingen, Department of Women's Health

Tübingen, Germany

RECRUITING

Outcomes

Primary Outcomes

CTC and DTC analysis

Counting the number of tumor cells in blood and bone marrow

Time frame: 12 months

HPV

Analysis of HPV types by DNA tests in peripheral blood, bone marrow, sentinel-lymph node, cervical-, endometrial- and myometrial-tissue, intraperitoneal wash fluid

Time frame: 12 months

DNA

Determination of DNA in peripheral blood

Time frame: 12 months

Douglas cytology

Intraperitoneal wash fluid

Time frame: 12 months

Proteomic analysis

Analysis of proteins by mass spectrometry in removed uterine and sentinel lymph node tissue

Time frame: 12 months

Sentinel lymph nodes

Number of detectable lymph nodes by Tc99m- and indocyanine green-labeling

Time frame: 12 months

Peripheral nerve conduction velocity

Intra- and interindividual comparison of N. obturatorius, N. pudendus between pre an post radical gynecological surgery

Time frame: 12 months

Urodynamic- cystomanometry between pre an post radical gynecological surgeryuroflowmetry

pressur/volume relationship

Time frame: 12 months

CTC and DTC analysis

Identification and quantification of genetic variants and mutations

Data from ClinicalTrials.gov

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