NCT01707862

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 1997

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1997

Completed
15.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
Last Updated

October 16, 2012

Status Verified

October 1, 2012

Enrollment Period

15.1 years

First QC Date

October 14, 2012

Last Update Submit

October 15, 2012

Conditions

Leiomyomatosis

Keywords

Intravenous leiomyomatosisSurgerySmooth muscle tumor

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

From March 1997 to June 2011, 6 women patients were admitted to our hospital with intravenous leiomyomatosis with intracardiac extension.

You may qualify if:

  • 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.

You may not qualify if:

  • Tumor markers were all within abnormal limits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Cardiovascular Disease

Beijing, China

Location

MeSH Terms

Conditions

LeiomyomatosisSmooth Muscle Tumor

Condition Hierarchy (Ancestors)

LeiomyomaNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Genetal Hospital Beijing Military Region, First class

    Institute of Cardiovascular Disease

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

October 14, 2012

First Posted

October 16, 2012

Study Start

March 1, 1997

Primary Completion

April 1, 2012

Study Completion

October 1, 2012

Last Updated

October 16, 2012

Record last verified: 2012-10

Locations

CN(1)