Fibroid Growth Study

子宫平滑肌瘤，通常称为纤维瘤，是育龄妇女的主要健康问题。本文所述研究的目的是调查临床相关女性人群中子宫平滑肌瘤的生长动力学。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异质性的假设，并且可以通过分子标记和细胞表型来区分肌瘤生长动力学的差异。参与者将包括300名绝经前妇女（>18岁），至少有一个子宫平滑肌瘤。患者入组的入选标准为超声确诊平滑肌瘤。至少有一个平滑肌瘤直径必须等于或大于5厘米，或者子宫必须扩大到怀孕第12周时的典型大小（表明存在许多平滑肌瘤）。在入组和知情同意后，将在首次访视时开始进行T1和T2加权磁共振成像（MRI）扫描，然后在3、6和12个月时进行。每位患者将进行体格检查，在每次MRI访视时提供尿液和血液样本，并回答最初的广泛电话问卷，然后每月更新简短的问卷。许多入组的女性将需要手术干预（子宫切除术/肌瘤切除术）作为标准治疗。当手术是入组研究的女性的结局时，将在手术前进行MRI，手术病理学家将绘制子宫平滑肌瘤图，以与MRI进行比较。将分析平滑肌瘤样本的组织病理学和与生长相关的分子变化。由于子宫切除术和子宫肌瘤切除术是子宫肌瘤患者的常见结局，我们预计研究中300名妇女中至少有100名可获得组织。我们将能够比较平滑肌瘤生长的多样性和位置的功能;检查平滑肌瘤生长和临床症状或结果之间的关系;确定不同生长动力学的平滑肌瘤的分子，细胞和病理特征;并检查子宫平滑肌瘤的差异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一个临床严重程度量表，并建立目前尚不能用于子宫平滑肌瘤的诊断标志物。 在过去的一年里，有85名妇女入学，其中非洲裔美国人略多于一半。

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.