Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

This research study is designed to work in cooperation with another study being conducted by the National Cancer Institute. The National Cancer Institute (NCI) is studying the effects of a drug called raloxifene on premenopausal women believed to have a high risk of developing breast cancer (98-C-0123).

In this study, researchers are interested in learning about the effects of raloxifene on the uterus and ovaries of the women participating in the NCI study. To do this researchers plan to conduct ultrasounds on the patients enrolled in the NCI study. In addition researchers plan to take samples of the lining of the uterus in these patients (endometrial biopsy) if found to be necessary.

The purpose of this study is to determine the reproductive effects of raloxifene on women who have normal functioning ovaries by taking ultrasounds of the ovaries and lining of the uterus (endometrium).

Raloxifene is a selective estrogen receptor-modulating agent that has been recently approved by the FDA for the treatment of osteoporosis in postmenopausal patients. A phase II trial evaluating the safety and efficacy of raloxifene in premenopausal patients at high risk for developing breast cancer has been recently approved by the IRB (98-C-0123). In this protocol, for assessment of the effects of raloxifene on the endometrium and ovaries, patients are scheduled to be studied with transvaginal sonography and hysterosonography, once during their menstrual cycle at periodic intervals. They are also scheduled to have endometrial biopsies as indicated. It is known that all SERMs (clomiphene, tamoxifen and in one small study raloxifene) raise the area under the curve of estradiol levels throughout the cycle in premenopausal women. Our study is designed to study the reproductive effects of raloxifene in these young women with competent ovaries using sonography of the ovaries and endometrium, and correlating it with steroid hormone levels which would be obtained under protocol 98-C-0123.

Effects of Raloxifene on the Uterus and Ovaries of Premenopausal Patients

Sonographic Evaluation of the Effects of Raloxifene on the Uterus and Ovaries in Premenopausal Patients at High Risk for Developing Breast Cancer

National Institutes of Health Clinical Center (CC)

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

SHG during surgery for endometrial cancer.

Sonohysterography

David M Kushner, MD

The purpose of study is to: 1) determine critical volume necessary to overcome tubal pressure and result in fluid dissemination and 2) evaluate functional viability of any disseminated tumor cells collected during SHG

Disseminated Endometrial Cancer Cells During Sonohysterography

The Incidence of Disseminated Endometrial Cancer Cells During Sonohysterography and Their Functional Viability: a Prospective Study

University of Wisconsin, Madison

Symptoms and General Pathology

Dilatation, Pathologic

The purpose of this study is to learn fluid from sonohysterography can be used to diagnose endometrial cancer.

Participants will have a sonohysterography (SHG) performed. Fluid will be collected after instillation of 5mls of saline and again after an adequate SHG is performed. A pathologist will review this fluid to see is cancer cells are present.

Cytologic Analysis of Distention Media as a Screening Test for Endometrial Cancer

American College of Obstetricians and Gynecologists

National Cancer Institute (NCI)

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Menorrhagia

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Gonadal Disorders

Endocrine System Diseases

Hemorrhage

Uterine Hemorrhage

Menstruation Disturbances

Catheter utilized in dual role: sonohysterography and endometrial biopsy

SonoBiopsy Catheter

Endometrial sample obtained without the assistance of sonohysterography

Endometrial biopsy catheter

Ricardo Mastellari, MD

To assess the adequacy of an endometrial biopsy sample obtained using sonohysterography.

Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology

Cook Group Incorporated

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Raloxifene on the Uterus and Ovaries of Premenopausal Patients	NCT00001837	Breast Cancer Breast Neoplasm		-	National Institutes of Health Clinical Center (CC)
Disseminated Endometrial Cancer Cells During Sonohysterography	NCT00205023	Endometrial Can...	Sonohysterograp...	18 Years -	University of Wisconsin, Madison
Cytologic Analysis of Distention Media as a Screening Test for Endometrial Cancer	NCT00462969	Endometrial Can...	Sonohysterograp...	18 Years -	University of Wisconsin, Madison
Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology	NCT01969396	Menorrhagia Endometrial Neo... Polycystic Ovar... Uterine Neoplas...	SonoBiopsy Cath... Endometrial bio...	18 Years -	Cook Group Incorporated

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