NCT01732432

Brief Summary

The purpose of this study is to determine whether a relationship exists between a previously established diagnosis of endometriosis and the consecutive risk of developing a clear cell or endometrioid ovarian carcinoma. All histopathological records since 1980 with these diagnoses (endometriosis, clear cell and endometrioid ovarian carcinoma) will be reviewed. Cancer registry data will be assessed to investigate differences in survival of women with endometriosis-associated ovarian carcinomas and those ovarian carcinoma patients without previous diagnosis of endometriosis.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2012

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

10 months

First QC Date

November 18, 2012

Last Update Submit

March 31, 2015

Conditions

Endometrioid CarcinomaClear Cell CarcinomaEndometriosis

Outcome Measures

Primary Outcomes (1)

  • incidence and clinical outcome of endometriosis-associated ovarian carcinomas

    30 years

Eligibility Criteria

Age30 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care hospital, university hospital

You may qualify if:

  • endometrioid ovarian carcinoma
  • clear cell ovarian carcinoma
  • endometriosis, atypical endometriosis
  • borderline tumors with endometriosis

You may not qualify if:

  • undifferentiated carcinomas
  • germ cell tumors
  • sex cord-stromal tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, EndometrioidAdenocarcinoma, Clear CellEndometriosis

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsEndometrial NeoplasmsUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteOvarian NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Ellen Obermann, MD, Dr.

    University Hospital Basel, University of Basel

    PRINCIPAL INVESTIGATOR

  • Ellen C Obermann, MD

    Institute of Pathology, University Hospital Basel, University of Basel

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2012

First Posted

November 22, 2012

Study Start

October 1, 2012

Primary Completion

August 1, 2013

Study Completion

December 1, 2013

Last Updated

April 1, 2015

Record last verified: 2015-03