LeiomyomatosisSIVLNCT01707862
Surgery for Intravenous Leiomyomatosis
An observational study of Leiomyomatosis, run by Li Yang at 1 site in China.
Trial summary
Intravenous leiomyomatosis (IVL) with intracardiac extension is a rare benign smooth muscle tumor. Reviewing literature, intracardiac extension of the IVL has been reported in at least 70 cases. Most are individual case reports. Surgical experience is not much. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Leiomyomatosis
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- Mar 1997to Oct 2012
- 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: From March 1997 to June 2011, 6 women patients were admitted to our hospital with intravenous leiomyomatosis with intracardiac extension.
Who may be able to join
- Age more than 18 years.
- Tumor markers were all within normal limits.
- Patients underwent surgical management.
- Patients were followed-up for more than 12 months.
Who cannot join
- -Tumor markers were all within abnormal limits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Management of Intravenous Leiomyomatosis With Intracardiac Extension: Our Experience and Outcomes
Intravenous leiomyomatosis (IVL) with intracardiac extension is a rare benign smooth muscle tumor. Reviewing literature, intracardiac extension of the IVL has been reported in at least 70 cases. Most are individual case reports. Surgical experience is not much. However, different opinion of surgical strategies remain controversial. The purpose of this report is to describe our experience of surgical management for the IVL with intracardiac extension.
Read the detailed description
All patients underwent surgical management. Clinical data were obtained from medical reports. Following-up was made through email and telephone.
- Conditions
- Leiomyomatosis
- Keywords
- Intravenous leiomyomatosis, Surgery, Smooth muscle tumor
- Medical subject headings
- Leiomyomatosis, Smooth Muscle Tumor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startMar 1997
- Primary completionApr 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeiomyomatosisStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Li Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Yang, General Hospital of Beijing PLA Military Region
- Investigators
- Genetal Hospital Beijing Military Region, First class, Principal investigator, Institute of Cardiovascular Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707862
- Sponsor's protocol ID
- GHBeijing-20121012
- Acronym
- SIVL
- Status last verified
- Oct 2012
- First submitted
- 14 Oct 2012
- Last updated
- 16 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Management of Intravenous Leiomyomatosis With Intracardiac Extension: Our Experience and Outcomes
- ClinicalTrials.gov ID
- NCT01707862
- Acronym / sponsor ID
- SIVL / GHBeijing-20121012
- Conditions
- Leiomyomatosis
- Keywords
- Intravenous leiomyomatosis, Surgery, Smooth muscle tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Li YangUniversity, hospital or other
- Study start
- Mar 1997
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 16 Oct 2012 (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.
Intravenous leiomyomatosis (IVL) with intracardiac extension is a rare benign smooth muscle tumor. Reviewing literature, intracardiac extension of the IVL has been reported in at least 70 cases. Most are individual case reports. Surgical experience is not much. However, different opinion of surgical strategies remain controversial. The purpose of this report is to describe our experience of surgical management for the IVL with intracardiac extension.
Detailed description
All patients underwent surgical management. Clinical data were obtained from medical reports. Following-up was made through email and telephone.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- From March 1997 to June 2011, 6 women patients were admitted to our hospital with intravenous leiomyomatosis with intracardiac extension.
Key inclusion criteria (4 listed)
- Age more than 18 years.
- Tumor markers were all within normal limits.
- Patients underwent surgical management.
- Patients were followed-up for more than 12 months.
Key exclusion criteria (1 listed)
- -Tumor markers were all within abnormal limits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2012.
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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.
Genetal Hospital Beijing Military Region, First class principal investigator
Institute of Cardiovascular Disease
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 Leiomyomatosis, run by Li Yang at 1 site in China.
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 4 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: finished, as of the sponsor's last update on 16 Oct 2012. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 16 Oct 2012.