Analysis and Optimization of Predictive and Therapeutic Models in Uterine Neoplasms

• Sponsor: University Hospital Tuebingen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03624712
• Collaborator: University Hospital Heidelberg (Other), University of Homburg (Other)
• Enrollment: 580
• Location: 1
• Anticipated Duration (Months): 131
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Uterine Neoplasms	Diagnostic Test: uterine neoplasms

Study Design

• Study Type: Observational
• Anticipated Enrollment: 580 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Prospective, Tricentric Open Trial on the Analysis and Optimization of Predictive and Therapeutic Models in Uterine Neoplasms
• Actual Study Start Date: Jan 1, 2012
• Anticipated Primary Completion Date: Jan 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. CTC and DTC analysis [12 months]

   Counting the number of tumor cells in blood and bone marrow

2. HPV [12 months]

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

3. DNA [12 months]

   Determination of DNA in peripheral blood

4. Douglas cytology [12 months]

   Intraperitoneal wash fluid

5. Proteomic analysis [12 months]

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

6. Sentinel lymph nodes [12 months]

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

7. Peripheral nerve conduction velocity [12 months]

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

8. Urodynamic- cystomanometry between pre an post radical gynecological surgeryuroflowmetry [12 months]

   pressur/volume relationship

9. CTC and DTC analysis [12 months]

   Identification and quantification of genetic variants and mutations

10. Urodynamic- urethral pressure profile between pre an post radical gynecological surgeryuroflowmetry [12 months]

    cm H20

11. Urodynamic- uroflowmetry between pre an post radical gynecological surgeryuroflowmetry [12 months]

    rate of flow of urine

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Tuebingen, Department of Women's Health	Tuebingen		Germany	72076

Sponsors and Collaborators

• University Hospital Tuebingen
• University Hospital Heidelberg
• University of Homburg

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital Tuebingen
• ClinicalTrials.gov Identifier: NCT03624712
• Other Study ID Numbers: ZGynO_DENOVA
• First Posted: Aug 10, 2018
• Last Update Posted: Jun 23, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms; Uterine Neoplasms

Study Results

No Results Posted as of Jun 23, 2021