MenopauseNCT00860886
Premenopausal Hormone Concentrations in a Population of Women at Very Low Risk of Breast Cancer
An observational study of Menopause and Normal Physiology, run by National Cancer Institute (NCI) at 1 site in Mongolia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 44 years, women only
- Conditions the study is for
- Menopause, Normal Physiology
- How many people
- 412 participants
- Where
- 1 siteMongolia
- Study dates
- 2 Mar 2009to 9 Apr 2020
- 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 25 to 44 years
- Women only
- No healthy volunteers
- Adult
Study population: Premenopausal women (ages 25-44)in Mongolia. These women were mothers of children attending several schools in Ulanbaatar (the capital).
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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Menopause, Normal Physiology
- Keywords
- Mongolia, Asia, GROWTH FACTORS, Hormones, Premenopausal, 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 |
|---|---|---|
| 1 | Mongolian Women | |
| 2 | Women in other parts of the world other than Mongolia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
hormone measurements
compare hormone measurements of Mongolian women with those of women in other parts of the world.
Measured: cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study start2 Mar 2009
- Primary completion15 Apr 2009
- Study completion9 Apr 2020
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 MenopauseStudies 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
- Cross-sectional
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert N Hoover, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860886
- Sponsor's protocol ID
- 999909078
- Other IDs
- 09-C-N078
- Status last verified
- Apr 2020
- First submitted
- 11 Mar 2009
- Last updated
- 10 Apr 2020
- Results posted
- No
Publications
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. doi: 10.1007/BF00053183.
PubMed 2102277Bolelli 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.
PubMed 7549807Falk 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. doi: 10.1038/sj.bjc.6600339.
PubMed 12085256
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premenopausal Hormone Concentrations in a Population of Women at Very Low Risk of Breast Cancer
- ClinicalTrials.gov ID
- NCT00860886
- Acronym / sponsor ID
- 999909078
- Conditions
- Menopause, Normal Physiology
- Keywords
- Mongolia, Asia, GROWTH FACTORS, Hormones, Premenopausal, 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
- 2 Mar 2009 (actual)
- Primary completion
- 15 Apr 2009 (actual)
- Study completion
- 9 Apr 2020 (actual)
- First posted
- 12 Mar 2009 (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.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Mongolian Women |
| 2 | – | –Women in other parts of the world other than Mongolia. |
Who may qualify
- Ages
- 25 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Premenopausal women (ages 25-44)in Mongolia. These women were mothers of children attending several schools in Ulanbaatar (the capital).
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-sectional
compare hormone measurements of Mongolian women with those of women in other parts of the world.
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 10 Apr 2020.
- Background: PubMed 2102277Bernstein 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. doi: 10.1007/BF00053183.
- Background: PubMed 7549807Bolelli 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.
- Background: PubMed 12085256Falk 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. doi: 10.1038/sj.bjc.6600339.
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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.
Robert N Hoover, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause and Normal Physiology, run by National Cancer Institute (NCI) at 1 site in Mongolia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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-sectional). 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 NCT00860886, 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 10 Apr 2020.