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Myomectomies:Tumor Characteristics and Clinical Implications

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ClinicalTrials.gov Identifier: NCT02671253
Recruitment Status : Unknown
Verified January 2016 by Päivi Päkarinen, Helsinki University Central Hospital.
Recruitment status was:  Recruiting
First Posted : February 2, 2016
Last Update Posted : February 2, 2016
Sponsor:
Collaborator:
University of Helsinki
Information provided by (Responsible Party):
Päivi Päkarinen, Helsinki University Central Hospital

Tracking Information
First Submitted Date January 25, 2016
First Posted Date February 2, 2016
Last Update Posted Date February 2, 2016
Study Start Date October 2015
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 31, 2016)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 31, 2016)
Pregnancy rate after myomectomy, data collected with questionnaire [ Time Frame: Five years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Myomectomies:Tumor Characteristics and Clinical Implications
Official Title Myomectomies:Tumor Characteristics and Clinical Implications
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women at age under 46 years undergoing myomectomy.
Condition
  • Uterine Myomectomy
  • Genetics
  • Quality of Life
  • Gynecologic Surgical Procedures
Intervention Procedure: Myomectomy
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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 31, 2016)
100
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Uterine leiomyoma
  • Seeking for surgery

Exclusion Criteria:

  • Language proficiency in Finnish, Swedish or English
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Finland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02671253
Other Study ID Numbers 24/13703/03/2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Päivi Päkarinen, Helsinki University Central Hospital
Study Sponsor Helsinki University Central Hospital
Collaborators University of Helsinki
Investigators
Principal Investigator: Päivi I Pakarinen, MD PhD Helsinki University Central Hospital
PRS Account Helsinki University Central Hospital
Verification Date January 2016