- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02671253
Myomectomies:Tumor Characteristics and Clinical Implications
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
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Päivi I Pakarinen, MD PhD
- Phone Number: 358504271531
- Email: paivi.pakarinen@hus.fi
Study Contact Backup
- Name: Anna K Äyräväinen, MD
- Phone Number: 35894711
- Email: anna.ayravainen@helsinki.fi
Study Locations
-
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Uterine leiomyoma
- Seeking for surgery
Exclusion Criteria:
- Language proficiency in Finnish, Swedish or English
Study Plan
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
Collaborators
Investigators
- Principal Investigator: Päivi I Pakarinen, MD PhD, Helsinki University Central Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 24/13703/03/2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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