Analysis and Optimization of Predictive and Therapeutic Models in Uterine Neoplasms

NCT03624712RecruitingOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

University Hospital Tuebingen

Enrollment

580

Start Date

2012-01-01

Completion Date

2027-12-01

Study Type

OBSERVATIONAL

Official Title

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

Interventions

uterine neoplasms

Conditions

Uterine Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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)

Outcome Measures

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

Time frame: 12 months

Urodynamic- urethral pressure profile between pre an post radical gynecological surgeryuroflowmetry

cm H20

Time frame: 12 months

Urodynamic- uroflowmetry between pre an post radical gynecological surgeryuroflowmetry

rate of flow of urine

Time frame: 12 months

Locations

University Hospital Tuebingen, Department of Women's Health, Tübingen, Germany

Analysis and Optimization of Predictive and Therapeutic Models in Uterine Neoplasms