Endocrine DiseasesNCT00903318
Male:Female Birth Ratios and Phthalate Levels
An observational study of Endocrine Diseases, run by M.D. Anderson Cancer Center at 3 sites in United States.
Trial summary
Objective 1: To assess environmental exposure to chemicals/toxins, including phthalates, among rural and urban Mexican American men and women (n=300), aged 18 to 40, in urban Baytown, TX and rural Rio Grande Valley (Hidalgo County) communities along the Texas-Mexico border region via survey. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Endocrine Diseases
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 May 2009to 9 Feb 2017
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Men and Women of Mexican American origin ages 18 to 40 years, residing in Baytown or the lower Rio Grande Valley in Hidalgo County, Texas for at least 45 years.
Who may be able to join
- Men and Women of Mexican American origin ages 18 to 40 years
- Residing in Baytown or the lower Rio Grande Valley in Hidalgo County, Texas
- Who have signed the informed consent
- Individuals will have had to reside in the study area for at least 5 years
- Pregnant women are eligible for the study.
Who cannot join
- 1) None
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Goose Creek Consolidated Independent School District
Baytown, Texas, 77521
Texas Southern University
Houston, Texas, 77004
LaJoya Independent School District
La Joya, Texas, 78560
About this study
Official title: Male:Female Birth Ratios and Phthalate Levels Along The Rural Lower Rio Grande Valley (Hidalgo County) and in Baytown, Texas
Objective 1: To assess environmental exposure to chemicals/toxins, including phthalates, among rural and urban Mexican American men and women (n=300), aged 18 to 40, in urban Baytown, TX and rural Rio Grande Valley (Hidalgo County) communities along the Texas-Mexico border region via survey.
Objective 2: To determine generational sex ratio trends in urban Baytown, TX and along the rural Rio Grande Valley (Hidalgo County) utilizing vital statistics data from the Texas Department of Health and the Center for Health Statistics.
Objective 3: To measure urinary phthalate levels and self-reported phthalate exposure in Mexican American men and women from urban Baytown, Texas and rural communities along the lower Rio Grande Valley (Hidalgo County) on theTexas-Mexico border. To conduct an optional procedure, chromosomal sex determination, among a subgroup of 50 persons (13 men + 12 women in each community) from participants who complete the survey in Objective 1.
Read the detailed description
Questionnaire:
If you agree to take part in this study, you will complete a questionnaire about your family's characteristics. For example, the questionnaire will have questions about your educational level, your eating habits, your health conditions, your family's income level, and how many people live in your house. The study doctor will also ask you questions about any drugs you may be taking. The questionnaire should take about 30-35 minutes to complete.
The completed paper questionnaire will be placed in a secured, locked cabinet and will be given a code number. Only the researcher in charge of the study will have access to the code numbers and be able to link the questionnaire to you. After the study ends and after information from the questionnaire has been entered in a password protected database, the paper copy of the questionnaire will be sent to M. D. Anderson to be stored for up to 5 years. After 5 years, it will be destroyed.
Urine Sample:
You will have a urine sample collected. Researchers will study the urine samples to learn what your level of exposure may be to certain chemicals in the environment, specifically chemicals called phthalates. Phthalate is the only chemical that will be measured.
Additional Information:
All information collected during this study will be kept strictly confidential, and will not contain any personal identifiable information such as your name, address, and/or telephone number. All the information will be will be given a code number. To protect confidentiality, DNA data will not be linked to participant identifiers. Only the researcher in charge of the study will have access to the code numbers and be able to link any information to you. All samples and DNA data will be destroyed within three years after the conclusion of the study.
Length of Study:
After the questionnaire is complete and the urine sample has been collected, your participation on this study will be over.
This is an investigational study. Up to 300 participants (150 from Baytown,TX and 150 from the rural lower Rio Grande Valley in Hidalgo County, TX) will take part in this study. All will be enrolled through M. D. Anderson.
- Conditions
- Endocrine Diseases
- Being tested
- Questionnaire
- Keywords
- Endocrine, Environmental Chemicals, Male:Female Birth Ratio, Phthalate Exposure, Generational sex ratio trends, Mexican American, Baytown, Rio Grande Valley, Hidalgo County, Texas
- Medical subject headings
- Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Questionnaire about family's characteristics taking about 30-35 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Mexican American Men and Women | Rural and urban Mexican American men and women , aged 18 to 40, in urban Baytown, TX and rural Rio Grande Valley (Hidalgo County) communities along the Texas-Mexico border Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of exposure to chemical/toxins (Survey Responses)
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2009 (estimated)
- Study start15 May 2009
- Primary completion9 Feb 2017
- Study completion9 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine DiseasesStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Richard A. Hajek, PHD, MS, BA, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903318
- Sponsor's protocol ID
- 2008-0742
- Other IDs
- 5P60MD000503
- Status last verified
- Feb 2017
- First submitted
- 15 May 2009
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Male:Female Birth Ratios and Phthalate Levels Along The Rural Lower Rio Grande Valley (Hidalgo County) and in Baytown, Texas
- ClinicalTrials.gov ID
- NCT00903318
- Acronym / sponsor ID
- 2008-0742
- Conditions
- Endocrine Diseases
- Keywords
- Endocrine, Environmental Chemicals, Male:Female Birth Ratio, Phthalate Exposure, Generational sex ratio trends, Mexican American, Baytown, Rio Grande Valley
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 15 May 2009 (actual)
- Primary completion
- 9 Feb 2017 (actual)
- Study completion
- 9 Feb 2017 (actual)
- First posted
- 18 May 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.
Objective 1: To assess environmental exposure to chemicals/toxins, including phthalates, among rural and urban Mexican American men and women (n=300), aged 18 to 40, in urban Baytown, TX and rural Rio Grande Valley (Hidalgo County) communities along the Texas-Mexico border region via survey.
Objective 2: To determine generational sex ratio trends in urban Baytown, TX and along the rural Rio Grande Valley (Hidalgo County) utilizing vital statistics data from the Texas Department of Health and the Center for Health Statistics.
Objective 3: To measure urinary phthalate levels and self-reported phthalate exposure in Mexican American men and women from urban Baytown, Texas and rural communities along the lower Rio Grande Valley (Hidalgo County) on theTexas-Mexico border. To conduct an optional procedure, chromosomal sex determination, among a subgroup of 50 persons (13 men + 12 women in each community) from participants who complete the survey in Objective 1.
Detailed description
Questionnaire:
If you agree to take part in this study, you will complete a questionnaire about your family's characteristics. For example, the questionnaire will have questions about your educational level, your eating habits, your health conditions, your family's income level, and how many people live in your house. The study doctor will also ask you questions about any drugs you may be taking. The questionnaire should take about 30-35 minutes to complete.
The completed paper questionnaire will be placed in a secured, locked cabinet and will be given a code number. Only the researcher in charge of the study will have access to the code numbers and be able to link the questionnaire to you. After the study ends and after information from the questionnaire has been entered in a password protected database, the paper copy of the questionnaire will be sent to M. D. Anderson to be stored for up to 5 years. After 5 years, it will be destroyed.
Urine Sample:
You will have a urine sample collected. Researchers will study the urine samples to learn what your level of exposure may be to certain chemicals in the environment, specifically chemicals called phthalates. Phthalate is the only chemical that will be measured.
Additional Information:
All information collected during this study will be kept strictly confidential, and will not contain any personal identifiable information such as your name, address, and/or telephone number. All the information will be will be given a code number. To protect confidentiality, DNA data will not be linked to participant identifiers. Only the researcher in charge of the study will have access to the code numbers and be able to link any information to you. All samples and DNA data will be destroyed within three years after the conclusion of the study.
Length of Study:
After the questionnaire is complete and the urine sample has been collected, your participation on this study will be over.
This is an investigational study. Up to 300 participants (150 from Baytown,TX and 150 from the rural lower Rio Grande Valley in Hidalgo County, TX) will take part in this study. All will be enrolled through M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mexican American Men and Women | – | Behavioral: QuestionnaireRural and urban Mexican American men and women , aged 18 to 40, in urban Baytown, TX and rural Rio Grande Valley (Hidalgo County) communities along the Texas-Mexico border |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Men and Women of Mexican American origin ages 18 to 40 years, residing in Baytown or the lower Rio Grande Valley in Hidalgo County, Texas for at least 45 years.
Key inclusion criteria (5 listed)
- Men and Women of Mexican American origin ages 18 to 40 years
- Residing in Baytown or the lower Rio Grande Valley in Hidalgo County, Texas
- Who have signed the informed consent
- Individuals will have had to reside in the study area for at least 5 years
- Pregnant women are eligible for the study.
Key exclusion criteria (1 listed)
- 1) None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: SurveyQuestionnaire about family's characteristics taking about 30-35 minutes to complete. | Behavioural | Mexican American Men and Women |
Primary outcome
Prevalence of exposure to chemical/toxins (Survey Responses)
Time frame: 3 Years
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 13 Feb 2017.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Richard A. Hajek, PHD, MS, BA principal investigator
M.D. Anderson Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endocrine Diseases, run by M.D. Anderson Cancer Center at 3 sites in United States.
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 5 inclusion and 1 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 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Prevalence of exposure to chemical/toxins (Survey Responses) (time frame: 3 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2017.