Clinical Trials Logo

Clinical Trial Summary

Background:

- Incidence of breast cancer is very low in Mongolia (6.6/100,000), especially in rural areas. Over the past 15 years, there has been considerable economic growth in Mongolia, resulting in migration to urban centers such as the capital, Ulaanbaatar, from areas with nomadic or semi-nomadic lifestyles. This recent migration offers an opportunity to study the endocrine profiles of premenopausal women as they acculturate to a more Western lifestyle.

Objectives:

- To obtain new data on premenopausal endocrine and growth factor concentrations to assess possible variations by migration status within Ulaanbaatar; that is, to compare women who have been living in Ulaanbaatar for the longest period of time with those who have recently moved to Ulaanbaatar.

- To compare data from Mongolia with data from the United States (and possibly China), where women are at higher risk of breast cancer.

Eligibility:

- A sample of 375 premenopausal women will be drawn from a larger sample of mothers whose children are participating in a study conducted by Harvard Medical School. Only mothers of girls will be included in this cross-sectional study. Women ages 25 44 years who are not pregnant or breastfeeding are eligible.

Design:

- A total of 30 ml (three 10 ml samples) of whole blood will be collected. Women will be asked to provide a spot urine sample. These samples will be sent periodically to the NCI biorespository during the course of the study for testing. A portion of a sample for each participant will be kept in Ulaanbaatar in case of problems in delivery to the United States.

- The following hormones will be evaluated: testosterone, androstenedione, dehydroepiandrosterone (DHEA), DHEA-sulfate, estrone, estradiol, estriol, progesterone, prolactin, placental lactogen, IGF-1 and IGFBP-3, VEGF, soluble endoglin, and possibly other angiogenic proteins.

- Socioeconomic status and medical and lifestyle information will be assessed by questionnaire, including ethnicity, occupation, education, and migration status (e.g., whether she moved from a rural area and time since migration). Breast cancer risk factors such as age at first pregnancy, age at first menstruation, gravidity (total number of pregnancies), parity (total number of childbirths), smoking status, alcohol use, and dietary intake will also be determined. (These questionnaires will have been pilot tested and revised before the start of this study.) The Global Physical Activity Questionnaire, developed by the World Health Organization, will assess physical activity.

- Mean and median premenopausal hormone concentrations of previously collected blood samples from women in the United States who are at high breast cancer risk will be compared with the Mongolian samples. In addition, Chinese data will be compared if available.


Clinical Trial Description

There are striking differences in breast cancer incidence rates between Asian and North American and Western European populations, but within Asia variation is also wide. Incidence in Mongolia is one of the lowest in the world (6.6/100,000) while China, its neighbor to the south, has about three times this rate (18.7/100,000). Furthermore, rates appear higher in urban than in rural areas in Mongolia. Over the last decade and a half Mongolia has experienced profound economic changes resulting in mass migration from a nomadic or semi-nomadic existence to a more western lifestyle in the capital city of Ulaanbaatar, and some back migration to rural areas. Together with the contrast in exposures between traditional and urban settings, migration presents the opportunity to study women as they acculturate to a more western lifestyle.

We propose collecting blood and urine samples from premenopausal Mongolian women living in UlaanBaatar, the capital of Mongolia, to describe concentrations of several steroid hormones and growth factors that play a role in breast cancer development. The purpose of the study is to assess whether endocrine profile differs by degree of Western acculturation among those who have recently migrated to the capital. Subjects will be recruited among mothers of girls participating in a study of milk consumption and hormonal status presently being conducted by our colleagues at Harvard Medical School. In addition to the blood draw and urine collection, participants will have their height and weight measured and will complete a questionnaire on reproductive and medical history, migration status and lifestyle factors. Premenopausal blood samples with accompanying information on medical history and lifestyle factors from women participating in Project Viva in Boston, Massachusetts will provide a comparison group of US women at high breast cancer risk.

In general, Asian countries have been treated as one entity and the substantial variation in breast cancer incidence among the countries that make up this large geographic area has not been addressed. This variation among Asian countries may provide further opportunity for hypothesis generating as we seek to determine what factors explain differences in breast cancer rates between populations. Studies of a range of biological parameters in premenopausal women among different racial/ethnic populations with varying breast cancer incidence would be informative. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00860886
Study type Observational
Source National Institutes of Health Clinical Center (CC)
Contact
Status Completed
Phase
Start date March 2, 2009
Completion date April 9, 2020

See also
  Status Clinical Trial Phase
Completed NCT04553029 - A Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate-to-severe Menopause-related Vasomotor Symptoms (MR-VMS)
Completed NCT03672513 - Short-term Supplementation, Bone Turnover and Antioxidant Status in Menopause N/A
Terminated NCT03642119 - Validation of an Objective Instrument to Measure Hot Flashes During Menopause
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04210583 - RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity N/A
Completed NCT06057896 - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Completed NCT05617287 - An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause N/A
Recruiting NCT05180266 - Therapeutic Touch and Music in The Menopausal Period N/A
Recruiting NCT04043520 - Bioenergetic Effects of Aging and Menopause (BEAM) Phase 4
Completed NCT03663075 - Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women N/A
Completed NCT03363997 - Pharmacokinetics and Pharmacodynamics of 3 Dosages of Estriol After Continuous Vaginal Administration for 21 Days Phase 1
Not yet recruiting NCT04724135 - Assessment of Menopause Related Quality of Life Among Health Professionals in University Hospitals of UMC in Nur-Sultan
Not yet recruiting NCT04728126 - Menopausal Symptoms and Burnout: Comparison of Occupational Health Issue Among Health Professionals in UMC Hospitals
Completed NCT02274571 - Raising Insulin Sensitivity in Post Menopause Early Phase 1
Completed NCT02253173 - Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women Phase 3
Completed NCT02430987 - Low Sexual Desire and Metabolic Syndrome N/A
Completed NCT01757340 - Calorie Restriction With Leucine Supplementation N/A
Recruiting NCT01488903 - A Cohort Research of Genetic Susceptibility for Common Obesity in Women N/A
Terminated NCT01633814 - Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women N/A
Completed NCT00599456 - Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women. N/A