HealthyNCT00005003
Genetic Component of Handedness
An observational study of Healthy, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Some functions are generally controlled by the right side of the brain and others by the left. One of the most easily observed examples of this "lateral specialization" of the brain is handedness-that is, a person's preference for using either the right or the left hand. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Healthy
- How many people
- 1,400 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2000to Apr 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Members of families meeting the following criteria are eligible to participate:
- Have two left-handed siblings.
- Have at least one right-handed parent with no other known left-handed first degree relatives.
Who cannot join
- All members of a family may be excluded if the right-handed parents or the left-handed siblings will not participate.
- Individuals in families whose left-handed siblings are under the age of eight are not eligible to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Official title: Mapping the Genetic Component of Hand-Use Preference
Some functions are generally controlled by the right side of the brain and others by the left. One of the most easily observed examples of this "lateral specialization" of the brain is handedness-that is, a person's preference for using either the right or the left hand. This study will try to determine how the genetic component of handedness is inherited. It will test the theory that a single gene is involved in determining handedness and will try to locate the gene.
Families with at least two left-handed siblings aged eight years or older and at least one right-handed parent are eligible to participate in this study.
Read more
The left-handed siblings and both parents will fill out a brief questionnaire on hand usage, obtain a tissue sample taken from inside the cheek, and return the questionnaire and the sample by mail to the study researchers. The tissue sample will be used for DNA gene mapping.
Participants will be given a kit and instructions for obtaining the sample, along with mailing envelopes. Cheek swab sampling basically involves using a small brush to gently brush a layer of cells off of the inner wall of the cheek and then dropping the brush tip into a preservative.
The information gained from this study may provide insight into aspects of brain development that can be of medical benefit in the future.
Read the detailed description
The purpose of this protocol, based on the hypothesis that human hand-use preference (handedness) is largely dependent on the action of a single locus, is to collect samples allowing us to map a "handedness gene" via detection of linkage to any of eight potential candidate genes/regions or via a whole or partial genome scan. We calculate that a full 300 marker genome scan of 100 parents and sibling pairs (allowing linkage analysis at 10 cM resolution), or the equivalent amount of data from partial scans of 300 families, has a high likelihood of allowing us to map the proposed gene. Eligible families, consisting of pairs of left-handed siblings plus at least one right-handed parent, were identified during Phase I of this study in 1996-1998, with approval from the now-lapsed FCRDC IRB. In Phase II of this study, we have collected cheek swab samples for DNA isolation from members of 100 eligible families for use in the mapping studies. DNA samples will not be linked back to individuals but grouped under a random family code that links to a database with limited information, including hand use preference and family structure. In the next phase, we wish to map the locus from cheek swab samples we have on hand.
- Conditions
- Healthy
- Keywords
- Handedness, Laterality, Linkage, VNTR/Dinucleotide, Dinucleotide, High-Frequency-Trait Analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2000 (estimated)
- Study startMar 2000
- Study completionApr 2006
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 HealthyStudies 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
- Enrolment
- 1,400 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005003
- Sponsor's protocol ID
- 000094
- Other IDs
- 00-C-0094
- Status last verified
- Apr 2006
- First submitted
- 23 Mar 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Corballis MC. The genetics and evolution of handedness. Psychol Rev. 1997 Oct;104(4):714-27. doi: 10.1037/0033-295x.104.4.714.
PubMed 9337630Dellatolas G, Luciani S, Castresana A, Remy C, Jallon P, Laplane D, Bancaud J. Pathological left-handedness. Left-handedness correlatives in adult epileptics. Brain. 1993 Dec;116 ( Pt 6):1565-74. doi: 10.1093/brain/116.6.1565.
PubMed 8293288Levin M, Nascone N. Two molecular models of initial left-right asymmetry generation. Med Hypotheses. 1997 Nov;49(5):429-35. doi: 10.1016/s0306-9877(97)90092-x.
PubMed 9421811
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping the Genetic Component of Hand-Use Preference
- ClinicalTrials.gov ID
- NCT00005003
- Acronym / sponsor ID
- 000094
- Conditions
- Healthy
- Keywords
- Handedness, Laterality, Linkage, VNTR/Dinucleotide, Dinucleotide, High-Frequency-Trait Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,400 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Mar 2000
- Study completion
- Apr 2006
- First posted
- 24 Mar 2000 (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.
Some functions are generally controlled by the right side of the brain and others by the left. One of the most easily observed examples of this "lateral specialization" of the brain is handedness-that is, a person's preference for using either the right or the left hand. This study will try to determine how the genetic component of handedness is inherited. It will test the theory that a single gene is involved in determining handedness and will try to locate the gene.
Families with at least two left-handed siblings aged eight years or older and at least one right-handed parent are eligible to participate in this study.
The left-handed siblings and both parents will fill out a brief questionnaire on hand usage, obtain a tissue sample taken from inside the cheek, and return the questionnaire and the sample by mail to the study researchers. The tissue sample will be used for DNA gene mapping.
Participants will be given a kit and instructions for obtaining the sample, along with mailing envelopes. Cheek swab sampling basically involves using a small brush to gently brush a layer of cells off of the inner wall of the cheek and then dropping the brush tip into a preservative.
The information gained from this study may provide insight into aspects of brain development that can be of medical benefit in the future.
Detailed description
The purpose of this protocol, based on the hypothesis that human hand-use preference (handedness) is largely dependent on the action of a single locus, is to collect samples allowing us to map a "handedness gene" via detection of linkage to any of eight potential candidate genes/regions or via a whole or partial genome scan. We calculate that a full 300 marker genome scan of 100 parents and sibling pairs (allowing linkage analysis at 10 cM resolution), or the equivalent amount of data from partial scans of 300 families, has a high likelihood of allowing us to map the proposed gene. Eligible families, consisting of pairs of left-handed siblings plus at least one right-handed parent, were identified during Phase I of this study in 1996-1998, with approval from the now-lapsed FCRDC IRB. In Phase II of this study, we have collected cheek swab samples for DNA isolation from members of 100 eligible families for use in the mapping studies. DNA samples will not be linked back to individuals but grouped under a random family code that links to a database with limited information, including hand use preference and family structure. In the next phase, we wish to map the locus from cheek swab samples we have on hand.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Have two left-handed siblings.
- Have at least one right-handed parent with no other known left-handed first degree relatives.
Key exclusion criteria (2 listed)
- All members of a family may be excluded if the right-handed parents or the left-handed siblings will not participate.
- Individuals in families whose left-handed siblings are under the age of eight are not eligible to participate.
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
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 9337630Corballis MC. The genetics and evolution of handedness. Psychol Rev. 1997 Oct;104(4):714-27. doi: 10.1037/0033-295x.104.4.714.
- Background: PubMed 8293288Dellatolas G, Luciani S, Castresana A, Remy C, Jallon P, Laplane D, Bancaud J. Pathological left-handedness. Left-handedness correlatives in adult epileptics. Brain. 1993 Dec;116 ( Pt 6):1565-74. doi: 10.1093/brain/116.6.1565.
- Background: PubMed 9421811Levin M, Nascone N. Two molecular models of initial left-right asymmetry generation. Med Hypotheses. 1997 Nov;49(5):429-35. doi: 10.1016/s0306-9877(97)90092-x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Healthy, run by National Cancer Institute (NCI) at 1 site 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 3 inclusion and 2 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 4 Mar 2008. 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005003, 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 4 Mar 2008.