Fibroid Growth Study

子宫肌瘤，俗称肌瘤，是育龄妇女的主要健康问题。本研究的目的是研究临床相关人群中子宫肌瘤的生长动态。我们将检验子宫肌瘤在其生长特征和临床症状或结果方面是不同的假设，以及子宫肌瘤生长动力学的差异可以通过分子标记和细胞表型来区分。参与者将包括300名患有至少一个子宫肌瘤的绝经前妇女(18岁)。纳入患者登记的标准是超声确诊为子宫肌瘤。至少有一个肌瘤的直径必须等于或大于5厘米，或者子宫必须增大到怀孕12周时的典型大小(表明存在许多肌瘤)。在登记和知情同意后，将从第一次就诊开始，然后在3、6和12个月进行T1和T2加权磁共振成像(MRI)扫描。每个患者都将进行体检，在每次核磁共振检查时提供尿样和血样，并对最初广泛的电话问卷进行回复，随后进行简短的每月问卷更新。许多登记的妇女将需要手术干预(子宫切除术/肌瘤切除术)作为标准护理。当参与研究的女性接受手术时，将在手术前进行MRI检查，外科病理学家将绘制子宫肌瘤的图谱，以便与MRI进行比较。将对平滑肌瘤样本进行组织病理学和与生长相关的分子变化分析。由于子宫切除和子宫肌瘤切除是子宫肌瘤患者的常见结果，我们预计在300名参与研究的女性中，至少有100人可以获得组织。我们将能够比较肌瘤生长作为多样性和位置的函数；检查肌瘤生长和临床症状或结果之间的关系；识别具有不同生长动力学的肌瘤的分子、细胞和病理特征；以及检查与子宫肌瘤不同生长动力学相关的内分泌参数和生活方式因素。这些数据可用于建立临床严重程度分级和建立目前尚不适用于子宫肌瘤的诊断标记物。 在过去的一年里，有85名女性入学，略高于非洲裔美国人的一半。

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 (>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 5 cm in diameter or the uterus must be enlarged to the size typical during the twelfth week of pregnancy (indicating many leiomyomas are present). 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. When 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. 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. In the past year, 85 women were enrolled, with slightly more than half of African American ethnicity.