Fibroid Growth Study
Condition: Uterine Leiomyomas
MeSH terms: Leiomyoma; Myofibroma
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Premenopausal women (18 years or older) with at least one uterine leiomyoma diagnosis
        confirmed by ultrasound. At least one fibroid must be equal to or greater than 2 cm in
        diameter and the uterus must be enlarged to the size typical during the eighth week of
        pregnancy.
      
Keywords: Neoplasms; Life Style/Endrocrinology; Magnetic Resonance Imaging; Molecular Characterization; Leiomyoma