Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340288
Status:
COMPLETED
Last Update Posted:
2020-01-06
First Post:
2006-06-19
Brief Title:
Fibroid Growth Study
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Fibroid Growth Study
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 hysterectomymyomectomy 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 hysterectomymyomectomy 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-E-N209 | None | None | None |