Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01961102
Other study ID # BHS-Gyn1
Secondary ID
Status Completed
Phase N/A
First received October 9, 2013
Last updated August 7, 2016
Start date May 2013
Est. completion date March 2016

Study information

Verified date December 2015
Source Krankenhaus Barmherzige Schwestern Linz
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Observational

Clinical Trial Summary

It is to be achieved that in postmenopausal women through the combination of Hysteroscopy and intraoperative rapid section a positive predictive value (PPV) regarding the objective illness like endometrial cancer or adenomatous hyperplasia of 100% so as a negative predictive value (NPV) of 99%.


Description:

If a patient fulfills the inclusion criteria, the surgeon decides intraoperatively due to the aspect in the hysteroscopy if it is a clearly benign result or if it looks suspicious or malign.

In case of a hysteroscopical benign result the patient will be informed about the result after the operation.

In case of a hysteroscopal suspicious or malignant aspect, the curettement will be sent for a rapid section. If the hysteroscopic result confirms the hysteroscopic suspicion the patient will be informed after the operation and the further treatment can be planned right away.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date March 2016
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Female
Age group 45 Years and older
Eligibility Inclusion Criteria:

- Postmenopausal status (more than 1 year of last menopausal bleeding)

- Postmenopausal vaginal bleeding

- Asymptomatic postmenopausal endometrial hyperplasia

- Understanding of the german language

- Signature and consent of the patient

Exclusion Criteria:

- Not able to understand and participate in the study

- Premenopausal status

- no informed consent

Study Design

Observational Model: Case-Only


Intervention

Procedure:
hysteroscopy/curettage in case of suspicious aspect will be done a rapid section


Locations

Country Name City State
Austria Department of Gynaecology, Barmherzige Schwestern Linz

Sponsors (1)

Lead Sponsor Collaborator
Krankenhaus Barmherzige Schwestern Linz

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary A negative predictive value of 99 % To get in combination of hysteroscopy and rapid section of the endometrial curettement a negative predictive value of 99% as well as a positive predictive value of 100%. Intraoperative No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05796518 - Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors N/A
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT06463028 - Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, Serabelisib With Paclitaxel, and Paclitaxel Alone in Patients With Advanced/Recurrent Endometrial Cancer Phase 2
Recruiting NCT06036836 - Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010) Phase 2
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Completed NCT03820024 - MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback N/A
Active, not recruiting NCT05082025 - Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations Phase 2
Active, not recruiting NCT00587886 - Estrogen, Diet, Genetics and Endometrial Cancer
Completed NCT05378152 - Assessing the Benefit of Pipelle Biopsy in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity N/A
Suspended NCT05124743 - HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
Recruiting NCT03876860 - An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis N/A
Recruiting NCT04569773 - Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer
Completed NCT04534309 - Behavioral Weight Loss Program for Cancer Survivors in Maryland N/A
Not yet recruiting NCT06366347 - ALPINE: Maintenance Letrozole/Abemaciclib vs Pembrolizumab Phase 2
Not yet recruiting NCT06073184 - Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium Phase 2
Not yet recruiting NCT05998798 - Revealing Engagement Patterns Among Endometrial Cancer Patients
Terminated NCT02907073 - Positron Emission Tomography (PET) Imaging Studies With NIS Reporter Phase 1/Phase 2
Completed NCT02413606 - ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More? N/A