OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer

NCT01961102 | Completed DMC

• 1 other identifier: BHS-Gyn1
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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%.

Conditions

Endometrial Cancer; Atypical Hyperplasia

Keywords

postmenopausal bleeding; postmenopausal hyperplasia; endometrial cancer; atypical hyperplasia; curettage; intraoperative rapid section

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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

Also known as: OSCAR Endo Study

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Postmenopausal women

You may qualify if:

• 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

You may not qualify if:

• Not able to understand and participate in the study
• Premenopausal status
• no informed consent

Sponsors & Collaborators

• Krankenhaus Barmherzige Schwestern Linz: lead

Study Sites (1)

Department of Gynaecology, Barmherzige Schwestern

Linz, 4020, Austria

Location

Related Publications (1)

• Hefler-Frischmuth K, Hirtl-Goergl E, Unterrichter V, Lafleur J, Brunnmayr-Petkin G, Moinfar F, Hefler L. One-stop clinical assessment of risk for endometrial hyperplasia (OSCAR-Endo): a fast-track protocol for evaluating endometrial pathologies. Arch Gynecol Obstet. 2017 Apr;295(4):959-964. doi: 10.1007/s00404-017-4326-8. Epub 2017 Mar 6.

  PMID: 28265757 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Hysteroscopy; Curettage

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 11, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: March 1, 2016
• Last Updated: August 9, 2016

Record last verified: 2015-12

Locations

AU (1)