Uterine NeoplasmsNCT03624712
Analysis and Optimization of Predictive and Therapeutic Models in Uterine Neoplasms
An observational study of Uterine Neoplasms, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Neoplasms
- What is being tested?
- uterine neoplasms
- How many people
- 580 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with operable or inoperable uterine malignancy (cervical cancer, endometrial cancer, sarcoma)
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tuebingen, Department of Women's Health
Tübingen, 72076
Miriam Linneweh, Dr, +4970712982211, miriam.linneweh@med.uni-tuebingen.de
About this study
Official title: Prospective, Tricentric Open Trial on the 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
- Conditions
- Uterine Neoplasms
- Being tested
- uterine neoplasms
- Medical subject headings
- Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uterine neoplasmsDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| uterine neoplasms | Women with operable and inoperable uterine malignomas (cervical cancer, endometrial cancer, uterine sarcoma) Receives: Diagnostic Test: uterine neoplasms |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTC and DTC analysis
Counting the number of tumor cells in blood and bone marrow
Measured: 12 months
HPV
Analysis of HPV types by DNA tests in peripheral blood, bone marrow, sentinel-lymph node, cervical-, endometrial- and myometrial-tissue, intraperitoneal wash fluid
Measured: 12 months
DNA
Determination of DNA in peripheral blood
Measured: 12 months
Douglas cytology
Intraperitoneal wash fluid
Measured: 12 months
Proteomic analysis
Analysis of proteins by mass spectrometry in removed uterine and sentinel lymph node tissue
Measured: 12 months
Sentinel lymph nodes
Number of detectable lymph nodes by Tc99m- and indocyanine green-labeling
Measured: 12 months
Peripheral nerve conduction velocity
Intra- and interindividual comparison of N. obturatorius, N. pudendus between pre an post radical gynecological surgery
Measured: 12 months
Urodynamic- cystomanometry between pre an post radical gynecological surgeryuroflowmetry
pressur/volume relationship
Measured: 12 months
CTC and DTC analysis
Identification and quantification of genetic variants and mutations
Measured: 12 months
Urodynamic- urethral pressure profile between pre an post radical gynecological surgeryuroflowmetry
cm H20
Measured: 12 months
Urodynamic- uroflowmetry between pre an post radical gynecological surgeryuroflowmetry
rate of flow of urine
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study startJan 2012
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Heidelberg, University of Homburg, University Hospital Freiburg
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624712
- Sponsor's protocol ID
- ZGynO_DENOVA
- Status last verified
- Jan 2025
- First submitted
- 4 Jul 2018
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Tricentric Open Trial on the Analysis and Optimization of Predictive and Therapeutic Models in Uterine Neoplasms
- ClinicalTrials.gov ID
- NCT03624712
- Acronym / sponsor ID
- ZGynO_DENOVA
- Conditions
- Uterine Neoplasms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- University Hospital Heidelberg, University of Homburg, University Hospital Freiburg
- Study start
- Jan 2012 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| uterine neoplasms | – | Diagnostic Test: uterine neoplasmsWomen with operable and inoperable uterine malignomas (cervical cancer, endometrial cancer, uterine sarcoma) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with operable or inoperable uterine malignancy (cervical cancer, endometrial cancer, sarcoma)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| uterine neoplasmsAnalysis 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 | Diagnostic test | uterine neoplasms |
Primary outcome
CTC and DTC analysis
Time frame: 12 months
Counting the number of tumor cells in blood and bone marrow
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
DNA
Time frame: 12 months
Determination of DNA in peripheral blood
Douglas cytology
Time frame: 12 months
Intraperitoneal wash fluid
Proteomic analysis
Time frame: 12 months
Analysis of proteins by mass spectrometry in removed uterine and sentinel lymph node tissue
Sentinel lymph nodes
Time frame: 12 months
Number of detectable lymph nodes by Tc99m- and indocyanine green-labeling
Peripheral nerve conduction velocity
Time frame: 12 months
Intra- and interindividual comparison of N. obturatorius, N. pudendus between pre an post radical gynecological surgery
Urodynamic- cystomanometry between pre an post radical gynecological surgeryuroflowmetry
Time frame: 12 months
pressur/volume relationship
CTC and DTC analysis
Time frame: 12 months
Identification and quantification of genetic variants and mutations
Urodynamic- urethral pressure profile between pre an post radical gynecological surgeryuroflowmetry
Time frame: 12 months
cm H20
Urodynamic- uroflowmetry between pre an post radical gynecological surgeryuroflowmetry
Time frame: 12 months
rate of flow of urine
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University Hospital Tuebingen, Department of Women's Health
Tübingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Neoplasms, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CTC and DTC analysis (time frame: 12 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.