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Analysis and Optimization of Predictive and Therapeutic Models in Uterine Neoplasms

ConditionUterine Neoplasms
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital Tuebingen

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • uterine neoplasms

    Diagnostic 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

Treatment groups

580 Participants
are divided into 1 treatment group
Group A: uterine neoplasms1 intervention

Trial outcomes

Primary outcomes

1

CTC and DTC analysis

Counting the number of tumor cells in blood and bone marrow

Time frame
12 months
2

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
3

DNA

Determination of DNA in peripheral blood

Time frame
12 months
4

Douglas cytology

Intraperitoneal wash fluid

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Tuebingen

Lead sponsor

University Hospital Heidelberg

Collaborator

University of Homburg

Collaborator

University Hospital Freiburg

Collaborator

Source ClinicalTrials.gov
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