Establishment of Fibroid Tissue Bank

Status Terminated

Clinical Trial Summary

The purpose of this study is to collect information and tissue samples from women with uterine fibroids. The samples will be used to study genes, proteins and other substances in order to better understand the disease process and improve fertility and reproductive health.

Women who are scheduled to undergo hysterectomy, myomectomy or other surgery due to uterine fibroids or to an unusual variant of fibroid disease, such as HLRCC or benign metastasizing leiomyomatosis, may be eligible for this study.

Tissue samples are collected from participants during surgery. The samples are coded and catalogued for research use. Data collected regarding the surgery include the sample location, surgery type, reason for surgery and the primary and secondary diagnoses. Additional data collected about the participant include date of birth, race, ethnicity, weight, height, smoking status, information about menstrual cycles, medications and family history.

Clinical Trial Description

The long term goal of this protocol is to create a repository of well-characterized fibroid (leiomyoma) tissues in order to gather information that will lead to improved understanding of uterine fibroid growth and pathogenesis. It is expected that this initiative will eventually improve fertility and reproductive health of the millions of women who suffer from fibroids.

To address the need for increased research in this field, the NICHD in collaboration with the Office of Research on Women s Health (ORWH) will establish a national fibroid tissue bank. This initiative will strengthen the science base, improve our understanding of how uterine fibroids develop and grow, and provide clues to more effective conservative management of fibroids. The rationale for this protocol is that a repository of well-characterized, well-preserved leiomyoma tissues will provide investigators interested in basic and translational research on fibroids the opportunity to study the condition. This will facilitate research because experiments conducted on the samples may be expected to improve understanding of the mechanism and pathophysiology of this disease. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00710346
Study type	Observational
Source	National Institutes of Health Clinical Center (CC)
Contact
Status	Terminated
Phase
Start date	June 30, 2008
Completion date	September 1, 2016

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04172272` - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures	N/A
Terminated	`NCT02940041` - Concordance Between Sonography Amd MRI for Presurgical Diagnosis of Uterine Mesenchymal Malignant Tumors
Withdrawn	`NCT00768742` - Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study	N/A
Completed	`NCT00152256` - A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids	Phase 3
Completed	`NCT00156195` - Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids	Phase 3
Completed	`NCT00160381` - A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids	Phase 3
Recruiting	`NCT04214457` - Development of a Predictive Model for Early Differential Diagnosis of Uterine Leiomyomas and Leiomyosarcomas
Completed	`NCT00044876` - Treatment of Uterine Fibroids With CDB-2914, an Experimental Selective Progesterone Receptor Antagonist	Phase 2
Completed	`NCT02889848` - Safety and Tolerability of Collagenase Clostridium Histolyticum (EN3835) to Treat Uterine Leiomyoma (Fibroids)	Phase 1
Recruiting	`NCT04145518` - Mechanistic Characterization of Uterine Pain	Phase 4
Completed	`NCT01816815` - Study in Healthy Tubal Ligated Women to Evaluate Pharmacodynamics, Safety and Pharmacokinetics of BAY1002670	Phase 1
Completed	`NCT00891657` - Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy	N/A
Completed	`NCT00156156` - Study of Asoprisnil in the Treatment of Uterine Fibroids.	Phase 3
Recruiting	`NCT05538689` - Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL)	Phase 4
Active, not recruiting	`NCT03323905` - Single Arm Study Using the Symphony -- MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas	N/A
Terminated	`NCT03342859` - Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Surgery is Planned	Phase 1
Recruiting	`NCT06135870` - Role of Senescent Cells in Uterine Fibroid Pathogenesis (SOUL Study)
Completed	`NCT02777203` - Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy	N/A
Completed	`NCT02189083` - Study of Tumor-shrinking Decoction (TSD) to Treat Symptomatic Uterine Fibroids	Phase 3
Completed	`NCT01123603` - Lower Urinary Tract Infection (UTI) Evaluation in Women With Uterine Leiomyomata	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.