Endometriosis and Frequency of Endometriosis-associated O... | NCT01732432

Studies
Endometriosis and Frequency of Endometriosis-associated Ovarian Carcinomas (EAOC)

NCT01732432

Sponsor

University Hospital, Basel, Switzerland

Status

Withdrawn

Last Update Posted

Apr 1, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Endometrioid Carcinoma
Clear Cell Carcinoma
Endometriosis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Aug 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Nov 18, 2012

First Submission Date that Met QC Criteria

Nov 18, 2012

First Posted Date

Nov 22, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2015

Last Update Posted Date

Apr 1, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence and clinical outcome of endometriosis-associated ovarian carcinomas		30 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

undifferentiated carcinomas
germ cell tumors
sex cord-stromal tumors

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

primary care hospital, university hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018269	Carcinoma, Endometrioid
D018262	Adenocarcinoma, Clear Cell
D004715	Endometriosis

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided