Myomectomies:Tumor Characteristics and Clinical Implications

January 31, 2016 updated by: Päivi Päkarinen, Helsinki University Central Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Procedure: Myomectomy

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Finland
- Huch
  - Helsinki, Huch, Finland, 00029
    - Recruiting
    - Kätilöopisto Maternity Hospital, Helsinki University hospital
    - Contact:
      
      Päivi I Pakarinen, MD PhD
      
      Phone Number: 358504271531
      
      Email: paivi.pakarinen@hus.fi
    - Contact:
      
      Anna K Äyräväinen, MD
      
      Phone Number: 35894711
      
      Email: anna.ayravainen@helsinki.fi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women at age under 46 years undergoing myomectomy.

Description

Inclusion Criteria:

Uterine leiomyoma
Seeking for surgery

Exclusion Criteria:

Language proficiency in Finnish, Swedish or English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Collaborators

University of Helsinki

Investigators

Principal Investigator: Päivi I Pakarinen, MD PhD, Helsinki University Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

January 31, 2016

First Posted (Estimate)

February 2, 2016

Study Record Updates

Last Update Posted (Estimate)