Trial Information

Fibroid Growth Study

Uterine leiomyomas, commonly called fibroids, are a major health concern for women of
reproductive age. The objectives of the study described herein are to investigate the
growth dynamics of uterine leiomyomas in a clinically relevant population of women. We will
test the hypotheses that uterine leiomyomas are heterogeneous in terms of their growth
characteristics and in their clinical symptoms or outcomes, and that differences in
leiomyoma growth dynamics can be discriminated by molecular markers and cellular phenotypes.
Participants will include 300 premenopausal women (greater than 18 years old) with at least
one uterine leiomyoma. The inclusion criteria for patient enrollment is confirmed diagnosis
of leiomyoma by ultrasound. At least one leiomyoma must be equal to or greater than 2 cm in
diameter and the uterus must be enlarged to the size typical during the eigth week of
pregnancy. After enrollment and informed consent, T1- and T2-weighted magnetic resonance
image (MRI) scans will be conducted beginning at the first visit and then at 3, 6, and 12
months. Each patient will have a physical exam, provide urine and blood samples at each MRI
visit, and respond to an initial extensive telephone-administered questionnaire followed by
abbreviated monthly questionnaire updates. A number of the enrolled women will require
surgical intervention (hysterectomy/myomectomy) as standard care. If surgery is an outcome
for women enrolled in the study, MRI will be conducted before surgery and the surgical
pathologist will map uterine leiomyomas for comparison to MRI. Leiomyoma samples will be
analyzed for histopathological and molecular changes correlated with growth. Because
hysterectomy and myomectomy are common outcomes in women with leiomyomas, we anticipate
tissue will be available from at least 100 of the 300 women in the study. For those women
who opt for surgery, we will also administer a brief (less than 5 minute) questionnaire
clarifying their reason for electing surgery. Upon completion of data collection, we will
be able to compare leiomyoma growth as a function of multiplicity and location; examine the
relationship between leiomyoma growth and clinical symptoms or outcome; identify molecular,
cellular, and pathological characteristics of leiomyomas with differing growth dynamics; and
examine endocrinological parameters and lifestyle factors related to differential growth
dynamics of uterine leiomyomas. The data may be used to establish a clinical severity scale
and establish diagnostic markers currently not available for uterine leiomyomas.