Fibroid Growth Study

肌瘤生长研究

• 批准号: 7007547
• 负责人: peddada
• 金额: --
• 依托单位: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7007547
• 关键词: biomarker; endocrinology; female; histopathology; human subject; leiomyoma; magnetic resonance imaging; neoplastic growth; questionnaires; reproductive system; uterus; women' s health

Uterine leomyomas, 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 include 123 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 2 cm in diameter or the uterus must be enlarged to the size typical during the eighth 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 1/3 of the participant population. The specific aims of the study are to: (1) investigate leiomyoma growth as a function of multiplicity and location; (2) examine the relationship between leiomyoma growth and clinical symptoms or outcome; (3) identify molecular, cellular, and pathological characteristics of leiomyomas with differing growth dynamics; and (4) 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, 35 women were enrolled; the total participant base includes 123 women; about 50% are African American; about 40% are Caucasian, and the remainder is of other minority backgrounds.

子宫肌瘤，通常称为肌瘤，是育龄妇女的主要健康问题。本研究的目的是研究子宫平滑肌瘤在临床相关人群中的生长动态。我们将检验子宫平滑肌瘤在其生长特征和临床症状或结果方面具有异质性的假设，并且平滑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。参与者包括123名绝经前妇女（bb0 - 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的平滑肌瘤。至少有一个平滑肌瘤的直径必须大于或等于2厘米，或者子宫必须扩大到怀孕第八周时的典型大小（表明存在许多平滑肌瘤）。入组并获得知情同意后，将在首次就诊时进行T1和t2加权磁共振成像（MRI）扫描，然后在第3、6和12个月时进行扫描。每位患者将接受体格检查，在每次核磁共振检查时提供尿液和血液样本，并回答最初广泛的电话问卷调查，随后每月简短的问卷更新。许多入选的妇女将需要手术干预（子宫切除术/子宫肌瘤切除术）作为标准治疗。当参与研究的女性需要进行手术时，将在手术前进行MRI检查，外科病理学家将绘制子宫平滑肌瘤图，与MRI进行比较。将分析平滑肌瘤样本与生长相关的组织病理学和分子变化。由于子宫切除术和子宫肌瘤切除术是平滑肌瘤妇女的常见结果，我们预计至少有1/3的参与者可获得组织。该研究的具体目的是：(1)研究平滑肌瘤的生长与多样性和位置的关系；(2)检查平滑肌瘤生长与临床症状或转归的关系；(3)鉴别具有不同生长动力学的平滑肌瘤的分子、细胞和病理特征；(4)探讨与子宫平滑肌瘤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临床严重程度量表和建立目前尚无的子宫平滑肌瘤的诊断标记。在过去的一年里，有35名女性被录取；总共有123名女性参与；大约50%是非洲裔美国人；大约40%是白种人，其余的是其他少数民族背景。