Premenopausal Hormone Concentrations in a Population of Women at Very Low Risk of Breast Cancer
Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Sponsored by: National Cancer Institute (NCI)
Rebecca Troisi, D.Sc., Phone: (301) 496-1691, Email: email@example.com
- 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
- 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.
- 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.
- 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
- 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
- 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
Official title: Premenopausal Hormone Concentrations in a Population of Women at Very Low Risk of Breast Cancer
Study design: Prospective
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.
Minimum age: 25 Years.
Maximum age: 44 Years.
- Participants will be drawn from a group of mothers whose children are participating
in a study that will be conducted by our colleagues at Harvard Medical School. The
Harvard study is a randomized trial among 750 3rd grade children (aged 9-11) to
determine the impact of various types of vitamin D fortified and unfortified milk and
vitamin D supplements on levels of 25(OHD), growth hormone, and IGF-1. Children in
this study will be recruited at eleven primary schools in Ulaanbaatar. The trial will
run from January through March 2009 and will include 375 girls; we estimate that
their mothers will be roughly 30-45 years of age, and few will be pregnant.
We plan to recruit participants for our study at the time of the baseline blood draw in
their daughters. Women ages 25-44 are eligible who are not pregnant or breastfeeding.
Locations and Contacts
Rebecca Troisi, D.Sc., Phone: (301) 496-1691, Email: firstname.lastname@example.org
Health Sciences University of Mongolia, Ulaanbaatar 210648, Mongolia; Recruiting
Harvard Medical School, Boston, Massachusetts 02115, United States; Recruiting
Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States; Recruiting
Brigham and Women's Hospital, Boston, Massachusetts 02115, United States; Recruiting
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Bolelli G, Muti P, Micheli A, Sciajno R, Franceschetti F, Krogh V, Pisani P, Berrino F. Validity for epidemiological studies of long-term cryoconservation of steroid and protein hormones in serum and plasma. Cancer Epidemiol Biomarkers Prev. 1995 Jul-Aug;4(5):509-13.
Falk RT, Fears TR, Hoover RN, Pike MC, Wu AH, Nomura AM, Kolonel LN, West DW, Ziegler RG. Does place of birth influence endogenous hormone levels in Asian-American women? Br J Cancer. 2002 Jul 1;87(1):54-60.
Starting date: February 2009
Last updated: August 24, 2009