Actively Recruiting
Prospective, Tricentric Open Trial on the Analysis and Optimization of Predictive and Therapeutic Models in Uterine Neoplasms
Led by University Hospital Tuebingen · Updated on 2025-01-17
580
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital Tuebingen
Lead Sponsor
U
University Hospital Heidelberg
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are examining new clinical, therapeutic, and prognostic findings to improve treatment models and develop a new algorithm for therapy in patients with uterine neoplasms, including cervical cancer, endometrial cancer, and uterine sarcoma. This observational study focuses on both operable and inoperable uterine malignancies to optimize predictive and therapeutic approaches. The study is sponsored by University Hospital Tuebingen and aims to enhance understanding and management of these cancers. The study involves analysis of circulating tumor cells (CTC) and disseminating tumor cells (DTC), detection of Human Papilloma Virus (HPV), Douglas cytology, DNA analysis in blood, proteomic analysis, and sentinel lymph node detection. These diagnostic tests are conducted to gather detailed information about the tumors and their spread. Participants with operable tumors may undergo laparoscopic, robot-assisted, or open radical gynecological surgery as part of their primary therapy. Participants will be involved in various assessments over a 12-month period, including cytology, proteomic, and DNA analyses, as well as urodynamic tests measuring nerve conduction velocity, cystomanometry, urethral pressure profiles, and uroflowmetry before and after surgery. These evaluations help monitor treatment effects and disease progression. The study requires participants to provide informed consent and to be willing and able to complete all study-specific procedures during the observation period.
CONDITIONS
Brief Title
Analysis and Optimization of Predictive and Therapeutic Models in Uterine Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed uterine malignancy such as cervical cancer, endometrial cancer, or uterine sarcoma
- If operable: scheduled for laparoscopic, robot-assisted, or open radical gynecological surgery as primary therapy
- Written informed consent provided
- Willingness and ability to participate in all study procedures
- Female aged 18 years or older
You will not qualify if you...
- Severe or acute general disease within the last 4 weeks
- Acute or chronic psychiatric disorders
- Other factors that could affect participation such as acute psychosocial stress, insufficient understanding of the study, or inadequate German language skills
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants undergo analysis of circulating and disseminating tumor cells, testing for Human Papilloma Virus, Douglas cytology, DNA and proteome analysis in blood, and sentinel lymph node detection.
Multiple visits over 12 months
Duration - Up to 12 months
Participants are monitored with assessments including peripheral nerve conduction velocity and urodynamic tests before and after radical gynecological surgery.
Multiple visits over 12 months
Trial Site Locations
Total: 1 location
1
University Hospital Tuebingen, Department of Women's Health
Tübingen, Germany, 72076
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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