Uterine MyomectomyNCT02671253
Myomectomies:Tumor Characteristics and Clinical Implications
An observational study of Uterine Myomectomy and Genetics, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Uterine Myomectomy, Genetics, Quality of Life
- What is being tested?
- Myomectomy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2015to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women at age under 46 years undergoing myomectomy.
Who may be able to join
- Uterine leiomyoma
- Seeking for surgery
Who cannot join
- Language proficiency in Finnish, Swedish or English
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Kätilöopisto Maternity Hospital, Helsinki University hospital
Helsinki, Huch, 00029
Päivi I Pakarinen, MD PhD, 358504271531, paivi.pakarinen@hus.fi
Anna K Äyräväinen, MD, 35894711, anna.ayravainen@helsinki.fi
About this study
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.
- Being tested
- Myomectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyomectomyProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life measured by a validated questionnaire (UFS-QOL)
UFS-QOL: Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire
Measured: Two years
Secondary outcomes (1)
Pregnancy rate after myomectomy, data collected with questionnaire
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startOct 2015
- Primary completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine MyomectomyStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Responsible party
- Principal investigator, Päivi Päkarinen, Helsinki University Central Hospital
- Investigators
- Päivi I Pakarinen, MD PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671253
- Sponsor's protocol ID
- 24/13703/03/2015
- Status last verified
- Jan 2016
- First submitted
- 25 Jan 2016
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myomectomies:Tumor Characteristics and Clinical Implications
- ClinicalTrials.gov ID
- NCT02671253
- Acronym / sponsor ID
- 24/13703/03/2015
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- Oct 2015
- Primary completion
- Jan 2018 (estimated)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women at age under 46 years undergoing myomectomy.
Key inclusion criteria (2 listed)
- Uterine leiomyoma
- Seeking for surgery
Key exclusion criteria (1 listed)
- Language proficiency in Finnish, Swedish or English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyomectomyThe 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. | Procedure or surgery | – |
Primary outcome
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
1 secondary outcome
Pregnancy rate after myomectomy, data collected with questionnaire
Time frame: Five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Päivi I Pakarinen, MD PhD principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Myomectomy and Genetics, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Päivi I Pakarinen, MD PhD (358504271531, paivi.pakarinen@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life measured by a validated questionnaire (UFS-QOL) (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2016.