Long Term Survivors in Ovarian Cancer | NCT03128294

Studies
Long Term Survivors in Ovarian Cancer

NCT03128294

Sponsor

University Medical Center Groningen

Status

Terminated

Last Update Posted

Apr 19, 2024Actual

Enrollment

69Actual

Phase

Not provided

Conditions

Ovarian Cancer

Interventions

Retrospective, cross-sectional descriptive analysis

Countries

Netherlands

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

Apr 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Data was not sufficiently complete and reliable for analysis (retrospective chart research)

Expanded Access Info

Start Date

Jan 2017Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Apr 20, 2017

First Submission Date that Met QC Criteria

Apr 20, 2017

First Posted Date

Apr 25, 2017Actual

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

Apr 17, 2024

Last Update Posted Date

Apr 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

In this study the investigators would like to explore the patient and tumour characteristics of long-term survivors of ovarian cancer (>10 years). Indentifiying the characteristics of long-term survivors not only helps find prognostic factors for survival but may aid in generating hypotheses for novel therapeutic strategies.

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

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

69Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
long-term survivors of ovarian cancer		long-term survivors of ovarian cancer	Other: Retrospective, cross-sectional descriptive analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Retrospective, cross-sectional descriptive analysis	Other	This study is a retrospective, cross-sectional descriptive analysis, and concerns the extraction of data from anonymised patient files. A database will be constructed and descriptive statistics will be used to summarise the data.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Indentifiying the characteristics of long-term survivors	Indentifiying the characteristics of long-term survivors	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

To achieve a large enough study population of approximately 80 subjects, patients surviving >10 years after treatment for stage IIIC/IV epithelial ovarian cancer in the past 25 years will be included from five hospitals. Patients were diagnosed between 1979 and 2006 and treated in the north of the Netherlands. A list of subjects fitting these inclusion criteria will be extracted from the National Cancer Registry (NKR).

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Long-term survivors of ovarian cancer (>10 years).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
A.K.L. Reyners, MD, PhD	University Medical Center Groningen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Groningen		Groningen		9713 GZ	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012189	Retrospective Studies

Ancestor Terms

ID	Term
D016022	Case-Control Studies
D016021	Epidemiologic Studies
D016020	Epidemiologic Study Characteristics
D004812	Epidemiologic Methods

Browse Leaves

Not provided

Browse Branches

Not provided