NCT03624712

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
580

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jan 2012Dec 2027

Study Start

First participant enrolled

January 1, 2012

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

15.9 years

First QC Date

July 4, 2018

Last Update Submit

January 15, 2025

Conditions

Uterine Neoplasms

Outcome Measures

Primary Outcomes (11)

  • CTC and DTC analysis

    Counting the number of tumor cells in blood and bone marrow

    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

    12 months

  • DNA

    Determination of DNA in peripheral blood

    12 months

  • Douglas cytology

    Intraperitoneal wash fluid

    12 months

  • Proteomic analysis

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

    12 months

  • Sentinel lymph nodes

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

    12 months

  • Peripheral nerve conduction velocity

    Intra- and interindividual comparison of N. obturatorius, N. pudendus between pre an post radical gynecological surgery

    12 months

  • Urodynamic- cystomanometry between pre an post radical gynecological surgeryuroflowmetry

    pressur/volume relationship

    12 months

  • CTC and DTC analysis

    Identification and quantification of genetic variants and mutations

    12 months

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

    cm H20

    12 months

  • Urodynamic- uroflowmetry between pre an post radical gynecological surgeryuroflowmetry

    rate of flow of urine

    12 months

Study Arms (1)

uterine neoplasms

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

Diagnostic Test: uterine neoplasms

Interventions

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

uterine neoplasms

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Tuebingen, Department of Women's Health

Tübingen, 72076, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood

MeSH Terms

Conditions

Uterine Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2018

First Posted

August 10, 2018

Study Start

January 1, 2012

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)