Study of Pregnancy Hormone Concentrations in Urban and Nomadic Mongolian Women

NCT01160549 | Completed

• 2 other identifiers: 99991015210-C-N152
• Study Type: observational
• Target: 412
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Pregnancy

Keywords

Pregnancy; Hormones; Mongolia; Asian; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Hormone measurements

  Assess whether the in utero environment differed in women living a traditional lifestyle compared with a more urban lifestyle, and by degree of Western acculturation among those who had recently migrated to the capital. In addition, we planned to study the endocrine profile of pre-menopausal women living in UlaanBaatar by their migration status among mothers of girls participating in a study of milk consumption and hormonal status conducted by our collaborators at Harvard Medical School. Reproductive hormones were measured and are being compared to those in women living in the UK.

  Cross sectionally

Study Arms (2)

Cases

Women living in rural environments

Controls

Women living in more urban environments

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Maternal and cord blood samples from pregnant Mongolian women and their offspring living in rural and urban areas (by administrative divisions, called aimags).

You may qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (4)

National University of Mongolia, School of Social Science

Baga Toirog, 14200, Mongolia

Location

Bulgan General Hospital

Ulaanbaatar, Mongolia

Location

Maternal and Child Health Research Center (MCHRC)

Ulaanbaatar, Mongolia

Location

Selenge General Hospital

Ulaanbaatar, Mongolia

Location

Related Publications (3)

• Ahsan H. Placental genes and breast cancer: can the offspring's or father's genotypes predict mother's risk? Epidemiology. 2003 Mar;14(2):251-3. doi: 10.1097/01.EDE.0000050696.19411.C0.

  PMID: 12606894 BACKGROUND

• Atamer Y, Erden AC, Demir B, Kocyigit Y, Atamer A. The relationship between plasma levels of leptin and androgen in healthy and preeclamptic pregnant women. Acta Obstet Gynecol Scand. 2004 May;83(5):425-30. doi: 10.1111/j.0001-6349.2004.00276.x.

  PMID: 15059152 BACKGROUND

• Bellamy L, Casas JP, Hingorani AD, Williams DJ. Pre-eclampsia and risk of cardiovascular disease and cancer in later life: systematic review and meta-analysis. BMJ. 2007 Nov 10;335(7627):974. doi: 10.1136/bmj.39335.385301.BE. Epub 2007 Nov 1.

  PMID: 17975258 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rebecca Troisi, D.Sc.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2010
• First Posted: July 12, 2010
• Study Start: August 1, 2010
• Primary Completion: July 15, 2013
• Study Completion: February 19, 2015
• Last Updated: March 16, 2020

Record last verified: 2020-03

Locations

MO (4)