Analysis and Optimization of Predictive and Therapeutic Models in Uterine Neoplasms

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

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 Overview

• Status: Recruiting
• Conditions: Uterine Neoplasms
• Intervention / Treatment: Diagnostic test: uterine neoplasms

• Study Type: Observational
• Enrollment (Estimated): 580

Contacts and Locations

Study Locations

• Germany
  • Tuebingen, Germany, 72076
    • Recruiting
    • University Hospital Tuebingen, Department of Women's Health
    • Contact: Miriam Linneweh, Dr; Phone Number: +4970712982211; Email: miriam.linneweh@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women with operable or inoperable uterine malignancy (cervical cancer, endometrial cancer, sarcoma)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
uterine neoplasms; Women with operable and inoperable uterine malignomas (cervical cancer, endometrial cancer, uterine sarcoma)	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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Collaborators: University Hospital Heidelberg; University Hospital Freiburg; University of Homburg

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 4, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Neoplasms; Uterine Neoplasms
• Other Study ID Numbers: ZGynO_DENOVA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No