Genetic PredispositionNCT04307719
Prevalence of Carriers of Genetic Diseases in the Mexican Jewish Community
An observational study of Genetic Predisposition and Carrier, Gestational, run by Anahuac University at 1 site in Mexico.
Trial summary
The Jewish Population is at an increased risk for genetic diseases, especially autosomal recessive, thus, screening should be done to determine carrier status of several genetic diseases. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Genetic Predisposition, Carrier, Gestational
- How many people
- 208 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jul 2020to 19 Apr 2021
- How long will I take part?
- 1 Day
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Representative sample of the Mexican Jewish Community of child-bearing age, of both sexes.
Who may be able to join
- Jewish Origin in at least 1 grandparent
- Members of one of the Jewish sub-Communities in Mexico City
Who cannot join
- Pregnant Women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Carriers of Genetic Diseases in the Mexican Jewish Community
The Jewish Population is at an increased risk for genetic diseases, especially autosomal recessive, thus, screening should be done to determine carrier status of several genetic diseases. In the Mexican Jewish Community, which is a very diverse community (regarding geographical origins), data of carrier status is unknown. The study aims to determine carrier prevalence for over 300 diseases using commercially available panels.
Read the detailed description
Background: Preconceptional screening of genetic diseases is currently a underused and very useful tool, especially in populations that are at risk to be carriers of genetic diseases, such as the Jewish people, with carrier rates as high as 1:4 for any autosomal recessive disease. The Mexican Jewish Community is one of these populations at-risk, and there is no modern genetic research of the carrier rates in this community.
Goals: This research project in the Mexican Jewish Community aims to determine the prevalence of carriers in the community in order to properly generate in the future, a systematic carrier screening in the community.
Research Plan: The investigators propose a descriptive, observational, cross-sectional study, in which a representative sample of the Mexican Jewish Community (Which composes of Ashkenazi, Sephardic and Middle-Eastern Jews) of 250 patients, in which we´ll collect a saliva sample with a collection kit. Furthermore, the sample will be sent to a private commercial laboratory to perform the Comprehensive Carrier Screening to analyze the 301 genes included in the test plus the 13 add-on genes.
Analysis: Other demographic variables will be collected from the patients at the time of the sample collection to identify possible risk factors (geographical origin, number of Jewish grandparents, history of genetic diseases, et. al) and a correlation analysis will be performed to verify the strength of those risk factors on the carrier status of the patients.
- Conditions
- Genetic Predisposition, Carrier, Gestational
- Keywords
- Carrier Screening, Jewish
- Medical subject headings
- Genetic Predisposition to Disease
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 |
|---|---|---|
| Mexican Jewish Community | Sample of Patients from the Mexican Jewish Community to be subjected to genetic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carrier Status for 300+ Genetic Diseases
Patients will be screened for over 300 genetic diseases to determine carrier status
Measured: 30 days after sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start1 Jul 2020
- Primary completion10 Apr 2021
- Study completion19 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic PredispositionStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 208 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Anahuac University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Morgenstern-Kaplan, Anahuac University
- Investigators
- Dan Morgenstern-Kaplan, MD, Principal investigator, Anahuac University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307719
- Sponsor's protocol ID
- 201944
- Status last verified
- Apr 2021
- First submitted
- 11 Mar 2020
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carriers of Genetic Diseases in the Mexican Jewish Community
- ClinicalTrials.gov ID
- NCT04307719
- Acronym / sponsor ID
- 201944
- Conditions
- Genetic Predisposition, Carrier, Gestational
- Keywords
- Carrier Screening, Jewish
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Anahuac UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 19 Apr 2021 (actual)
- First posted
- 13 Mar 2020 (actual)
- 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.
The Jewish Population is at an increased risk for genetic diseases, especially autosomal recessive, thus, screening should be done to determine carrier status of several genetic diseases. In the Mexican Jewish Community, which is a very diverse community (regarding geographical origins), data of carrier status is unknown. The study aims to determine carrier prevalence for over 300 diseases using commercially available panels.
Detailed description
Background: Preconceptional screening of genetic diseases is currently a underused and very useful tool, especially in populations that are at risk to be carriers of genetic diseases, such as the Jewish people, with carrier rates as high as 1:4 for any autosomal recessive disease. The Mexican Jewish Community is one of these populations at-risk, and there is no modern genetic research of the carrier rates in this community.
Goals: This research project in the Mexican Jewish Community aims to determine the prevalence of carriers in the community in order to properly generate in the future, a systematic carrier screening in the community.
Research Plan: The investigators propose a descriptive, observational, cross-sectional study, in which a representative sample of the Mexican Jewish Community (Which composes of Ashkenazi, Sephardic and Middle-Eastern Jews) of 250 patients, in which we´ll collect a saliva sample with a collection kit. Furthermore, the sample will be sent to a private commercial laboratory to perform the Comprehensive Carrier Screening to analyze the 301 genes included in the test plus the 13 add-on genes.
Analysis: Other demographic variables will be collected from the patients at the time of the sample collection to identify possible risk factors (geographical origin, number of Jewish grandparents, history of genetic diseases, et. al) and a correlation analysis will be performed to verify the strength of those risk factors on the carrier status of the patients.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mexican Jewish Community | – | –Sample of Patients from the Mexican Jewish Community to be subjected to genetic testing |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Representative sample of the Mexican Jewish Community of child-bearing age, of both sexes.
Key inclusion criteria (2 listed)
- Jewish Origin in at least 1 grandparent
- Members of one of the Jewish sub-Communities in Mexico City
Key exclusion criteria (1 listed)
- Pregnant Women
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
Carrier Status for 300+ Genetic Diseases
Time frame: 30 days after sample collection
Patients will be screened for over 300 genetic diseases to determine carrier status
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 21 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Dan Morgenstern-Kaplan, MD principal investigator
Anahuac University
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 Genetic Predisposition and Carrier, Gestational, run by Anahuac University at 1 site in Mexico.
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 2 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 21 Apr 2021. 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 Mexico. 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?
Carrier Status for 300+ Genetic Diseases (time frame: 30 days after sample collection). 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 21 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.