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NCT Number: NCT03624712

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

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Key information

Conditions

Uterine Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Tuebingen, Department of Women's Health

Tübingen, 72076, Germany

Location status: Recruiting

Location contact

Miriam Linneweh, Dr

CONTACT

[email protected]

+4970712982211

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. CTC and DTC analysis

    Time frame: 12 months

    Counting the number of tumor cells in blood and bone marrow

  2. HPV

    Time frame: 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

    Time frame: 12 months

    Determination of DNA in peripheral blood

  4. Douglas cytology

    Time frame: 12 months

    Intraperitoneal wash fluid

  5. Proteomic analysis

    Time frame: 12 months

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

  6. Sentinel lymph nodes

    Time frame: 12 months

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

  7. Peripheral nerve conduction velocity

    Time frame: 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

    Time frame: 12 months

    pressur/volume relationship

  9. CTC and DTC analysis

    Time frame: 12 months

    Identification and quantification of genetic variants and mutations

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

    Time frame: 12 months

    cm H20

  11. Urodynamic- uroflowmetry between pre an post radical gynecological surgeryuroflowmetry

    Time frame: 12 months

    rate of flow of urine

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • University Hospital Freiburg
  • University Hospital Heidelberg
  • University of Homburg

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2027
Study completion
2027
First posted
Aug 10, 2018
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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