Menopause Clinical Trial
Official title:
Premenopausal Hormone Concentrations in a Population of Women at Very Low Risk of Breast Cancer
Verified date | April 2020 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 412 |
Est. completion date | April 9, 2020 |
Est. primary completion date | April 15, 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 44 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Mongolia | Health Sciences University of Mongolia | Ulaanbaatar |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
Mongolia,
Bernstein L, Yuan JM, Ross RK, Pike MC, Hanisch R, Lobo R, Stanczyk F, Gao YT, Henderson BE. Serum hormone levels in pre-menopausal Chinese women in Shanghai and white women in Los Angeles: results from two breast cancer case-control studies. Cancer Causes Control. 1990 Jul;1(1):51-8. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | hormone measurements | compare hormone measurements of Mongolian women with those of women in other parts of the world. | cross-sectional |
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