Study of Pregnancy Hormone Concentrations in Urban and Nomadic Mongolian Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01160549
First received: July 9, 2010
Last updated: March 14, 2014
Last verified: February 2014
  Purpose

International variation in breast cancer rates and data from migrant and animal studies support the possibility that exposures early in development, including the in utero period, play a role in breast carcinogenesis. One of the most striking prenatal influences on breast cancer risk is whether the woman was born in a country with a low or high breast cancer incidence. This observation has led to interest in the degree to which in utero exposures vary by the maternal environment, and to the hypothesis that alterations in prenatal concentrations of steroid hormones, particularly estrogens, and other biologic parameters to which the fetus is exposed mediate differences in subsequent breast cancer risk.

There are striking differences in breast cancer incidence rates between Asian and North American and Western European populations, but variation within Asia 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. 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. 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 maternal and cord blood samples from pregnant Mongolian women and their offspring living in rural and urban areas to describe concentrations of several steroid hormones and growth factors. The purpose of the study is to assess whether the in utero environment differs in women living a traditional lifestyle compared with a more urban lifestyle, and by degree of western acculturation among those who have recently migrated to the capital. Maternal and cord blood samples from an ongoing cohort study being conducted at the University of Pittsburgh will provide a comparison group of US women.


Condition
Breast Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Study of Pregnancy Hormone Concentrations in Urban and Nomadic Mongolian Women

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1000
Study Start Date: June 2010
Detailed Description:

The National Cancer Institute has been conducting research in countries around the world with the purpose of documenting international differences in hormone and growth factor levels with the intent of trying to understand how these relate to health. In particular, recent evidence suggests that hormones and growth factors very early in life may affect later disease risk. Dr. Ganmaa, a native Mongolian physician and Harvard-trained scientist suggested including Mongolia as one of the research settings for the NCI multi-centered study since the country offers a distinct population with unique lifestyles and traditions.

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. 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.

Mongolia provides a unique opportunity to assess whether differences in urban and rural lifestyles and behaviors influence health. The purpose of the study is to assess whether the pregnancy environment differs in women living a traditional lifestyle compared with a more urban lifestyle, and by degree of western acculturation among those who have recently migrated to the capital. We plan to compare steroid hormones and growth factors in maternal and cord blood samples from pregnant Mongolian women living in rural and urban areas with pregnant women from the US (at Brigham and Women's Hospital in Boston), UK (the Avon Longitudinal Study of Parents and Children), Norway (the Norwegian Mother and Child Cohort) and outside Beijing, China (CDC's randomized trial of pregnancy supplements).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Eligible for study are pregnant women 18 years of age or older, with singleton, presumed to be viable pregnancies that were naturally conceived, who receive prenatal care at the Maternity Hospital in UlaanBaatar (MCHRC) or the Bulgan and Selenge General Hospitals.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160549

Contacts
Contact: Rebecca Troisi, D.Sc. (301) 496-1691 troisir@mail.nih.gov

Locations
Mongolia
Maternal and Child Health Research Center (MCHRC) Recruiting
Ulaanbaatar, Mongolia
Bulgan General Hospital Recruiting
Ulaanbaatar, Mongolia
Selenge General Hospital Recruiting
Ulaanbaatar, Mongolia
Sponsors and Collaborators
Investigators
Principal Investigator: Rebecca Troisi, D.Sc. National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01160549     History of Changes
Other Study ID Numbers: 999910152, 10-C-N152
Study First Received: July 9, 2010
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Pregnancy
Hormones
Mongolia
Asian
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014