Myomectomies:Tumor Characteristics and Clinical Implications | NCT02671253

Studies
Myomectomies:Tumor Characteristics and Clinical Implications

NCT02671253

Sponsor

Helsinki University Central Hospital

Status

Unknown status

Last Update Posted

Feb 2, 2016Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Uterine Myomectomy
Genetics
Quality of Life
Gynecologic Surgical Procedures

Interventions

Myomectomy

Countries

Finland

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

Jan 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Jan 2018Estimated

Completion Date

Not provided

First Submitted Date

Jan 25, 2016

First Submission Date that Met QC Criteria

Jan 31, 2016

First Posted Date

Feb 2, 2016Estimated

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

Jan 31, 2016

Last Update Posted Date

Feb 2, 2016Estimated

Name	Class
University of Helsinki	OTHER

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

This project focuses on myomectomy patients in reproductive age. The aim is to study both the molecular characteristics of uterine fibroids and to characterize the clinical effects of surgical treatment.

Patient series is mainly retrospective and consists of individuals who have undergone myomectomy at Helsinki University Central Hospital (HUCH) during 2009-2015. In addition, the investigators have started a prospective sample collection starting in October 2015, collecting samples from myomectomies.

Clinical data sources include medical records, specific questionnaires and a quality of life -questionnaire filled by patients.

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

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Myomectomy	Procedure	The patient series consists of consecutive patients scheduled for elective laparotomic, traditional laparoscopic or robotic assisted laparoscopic myomectomy. The surgical method is selected based on clinician´s preference.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of life measured by a validated questionnaire (UFS-QOL)	UFS-QOL: Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire	Two years

Secondary Outcomes

Measure	Description	Time Frame
Pregnancy rate after myomectomy, data collected with questionnaire		Five years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Uterine leiomyoma
Seeking for surgery

Exclusion Criteria:

Language proficiency in Finnish, Swedish or English

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Women at age under 46 years undergoing myomectomy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Päivi I Pakarinen, MD PhD	Contact	358504271531		paivi.pakarinen@hus.fi
Anna K Äyräväinen, MD	Contact	35894711		anna.ayravainen@helsinki.fi

Overall Officials

Name	Affiliation	Role
Päivi I Pakarinen, MD PhD	Helsinki University Central Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kätilöopisto Maternity Hospital, Helsinki University hospital	Recruiting	Helsinki	Huch	00029	Finland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D063186	Uterine Myomectomy

Ancestor Terms

ID	Term
D013509	Gynecologic Surgical Procedures
D013519	Urogenital Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

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Browse Branches

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