Analysis and Optimization of Predictive and Therapeutic Models in Uterine Neoplasms

NCT ID: NCT03624712

Last Updated: 2025-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

580 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2027-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Uterine Neoplasms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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uterine neoplasms

Women with operable and inoperable uterine malignomas (cervical cancer, endometrial cancer, uterine sarcoma)

uterine neoplasms

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Heidelberg

OTHER

Sponsor Role collaborator

University of Homburg

OTHER

Sponsor Role collaborator

University Hospital Freiburg

OTHER

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Tuebingen, Department of Women's Health

Tübingen, , Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Miriam Linneweh, Dr

Role: primary

+4970712982211

Other Identifiers

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ZGynO_DENOVA

Identifier Type: -

Identifier Source: org_study_id

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