Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 77070 for:    Neoplasms

Analysis and Optimization of Predictive and Therapeutic Models in Uterine Neoplasms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03624712
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Collaborators:
University Hospital Heidelberg
University of Homburg
Information provided by (Responsible Party):
University Hospital Tuebingen

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
Uterine Neoplasms Diagnostic Test: uterine neoplasms

Layout table for study information
Study Type : Observational
Estimated 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 : January 2012
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Uterine Cancer

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




Primary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
peripheral blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with operable or inoperable uterine malignancy (cervical cancer, endometrial cancer, sarcoma)
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624712


Locations
Layout table for location information
Germany
University Hospital Tuebingen, Department of Women's Health Recruiting
Tuebingen, Germany, 72076
Contact: Miriam Linneweh, Dr    +4970712982211    miriam.linneweh@med.uni-tuebingen.de   
Sponsors and Collaborators
University Hospital Tuebingen
University Hospital Heidelberg
University of Homburg

Layout table for additonal information
Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03624712     History of Changes
Other Study ID Numbers: ZGynO_DENOVA
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: July 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female