PregnancyNCT01160549
Study of Pregnancy Hormone Concentrations in Urban and Nomadic Mongolian Women
An observational study of Pregnancy, run by National Cancer Institute (NCI) at 4 sites in Mongolia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy
- How many people
- 412 participants
- Where
- 4 sitesMongolia
- Study dates
- 1 Aug 2010to 19 Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
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).
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
Mongolia4 sites
National University of Mongolia, School of Social Science
Baga Toirog, 14200
Bulgan General Hospital
Ulaanbaatar
Maternal and Child Health Research Center (MCHRC)
Ulaanbaatar
Selenge General Hospital
Ulaanbaatar
About this study
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.
Read the 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).
- Conditions
- Pregnancy
- Keywords
- Pregnancy, Hormones, Mongolia, Asian, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Women living in rural environments | |
| Controls | Women living in more urban environments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Cross sectionally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study start1 Aug 2010
- Primary completion15 Jul 2013
- Study completion19 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Rebecca Troisi, D.Sc., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160549
- Sponsor's protocol ID
- 999910152
- Other IDs
- 10-C-N152
- Status last verified
- Mar 2020
- First submitted
- 9 Jul 2010
- Last updated
- 16 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 12606894Atamer 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.
PubMed 15059152Bellamy 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.
PubMed 17975258
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pregnancy Hormone Concentrations in Urban and Nomadic Mongolian Women
- ClinicalTrials.gov ID
- NCT01160549
- Acronym / sponsor ID
- 999910152
- Conditions
- Pregnancy
- Keywords
- Pregnancy, Hormones, Mongolia, Asian, Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Aug 2010 (actual)
- Primary completion
- 15 Jul 2013 (actual)
- Study completion
- 19 Feb 2015 (actual)
- First posted
- 12 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Women living in rural environments |
| Controls | – | –Women living in more urban environments |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hormone measurements
Time frame: Cross sectionally
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Background: PubMed 12606894Ahsan 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.
- Background: PubMed 15059152Atamer 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.
- Background: PubMed 17975258Bellamy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Troisi, D.Sc. principal investigator
National Cancer Institute (NCI)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by National Cancer Institute (NCI) at 4 sites in Mongolia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Mongolia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hormone measurements (time frame: Cross sectionally). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01160549, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020.