Acquired Immunodeficiency SyndromeNCT00001500
Genetic Factors and Interrelationships for Cancer Risk-Related Behaviors and Complex Traits
An observational study of Acquired Immunodeficiency Syndrome and Alcoholism, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
We propose to conduct a multifactorial genetic study of cancer risk-related behaviors and other complex human characteristics. The main areas of interest are tobacco smoking, excess alcohol consumption, psychological traits, and HIV/AIDS susceptibility and progression. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acquired Immunodeficiency Syndrome, Alcoholism, HIV Infection
- How many people
- 4,500 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1996to Jul 2004
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The basic requirement for entry in the study will be the presence of any individual smoker who is willing to complete the evaluation process and donate a blood sample.
- Additional siblings will be encouraged but not required to participate.
- Probands will be recruited through smoking cessation programs at the National Naval Medical Center.
- Attendees at programs offered by the Health Promotions Department and the Military Family Health Center will be invited to participate in this study.
Who cannot join
- All subjects will be adults (greater than 18 years).
- There will be no exclusions based on sex, ethnic group, or race.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
We propose to conduct a multifactorial genetic study of cancer risk-related behaviors and other complex human characteristics. The main areas of interest are tobacco smoking, excess alcohol consumption, psychological traits, and HIV/AIDS susceptibility and progression. The subjects will be adult male and female probands who display one or more of the phenotypes of interest together with their brothers, sisters and parents. Information on tobacco and alcohol use, psychological and personality traits, sexual behavior, HIV status and progression, and other characteristics with possible genetic components will be obtained through structured interviews and questionnaires. DNA will be prepared from blood samples and typed for a series of candidate genes chosen for function and for random polymorphic markers. By correlating the genotypic and phenotypic information, we hope to identify individual loci that interactively contribute to many different aspects of human health and disease.
Read the detailed description
We propose to conduct a multifactorial genetic study of cancer risk-related behaviors and other complex human characteristics. The main areas of interest are tobacco smoking, excess alcohol consumption, psychological traits, and HIV/AIDS susceptibility and progression. The subjects will be adult male and female probands who display one or more of the phenotypes of interest together with their brothers, sisters and parents. Information on tobacco and alcohol use, psychological and personality traits, sexual behavior, HIV status and progression, and other characteristics with possible genetic components will be obtained through structured interviews and questionnaires. DNA will be prepared from blood samples and typed for a series of candidate genes chosen for function and for random polymorphic markers. By correlating the genotypic and phenotypic information, we hope to identify individual loci that interactively contribute to many different aspects of human health and disease.
- Conditions
- Acquired Immunodeficiency Syndrome, Alcoholism, HIV Infection, Neoplasm, Smoking
- Keywords
- Smoking, Alcohol, HIV, AIDS, DNA Markers, Personality, Healthy Volunteers, Normal Volunteer
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Alcoholism, HIV Infections, Neoplasms, Smoking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startApr 1996
- Study completionJul 2004
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 Acquired Immunodeficiency SyndromeStudies 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
- 4,500 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001500
- Sponsor's protocol ID
- 960061
- Other IDs
- 96-C-0061
- Status last verified
- Jul 2004
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Carmelli D, Swan GE, Robinette D, Fabsitz RR. Heritability of substance use in the NAS-NRC Twin Registry. Acta Genet Med Gemellol (Roma). 1990;39(1):91-8. doi: 10.1017/s0001566000005602.
PubMed 2392895Carmelli D, Swan GE, Robinette D, Fabsitz R. Genetic influence on smoking--a study of male twins. N Engl J Med. 1992 Sep 17;327(12):829-33. doi: 10.1056/NEJM199209173271201.
PubMed 1508241Swan GE, Carmelli D, Rosenman RH, Fabsitz RR, Christian JC. Smoking and alcohol consumption in adult male twins: genetic heritability and shared environmental influences. J Subst Abuse. 1990;2(1):39-50. doi: 10.1016/s0899-3289(05)80044-6.
PubMed 2136102
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
- Genetic Factors and Interrelationships for Cancer Risk-Related Behaviors and Complex Traits
- ClinicalTrials.gov ID
- NCT00001500
- Acronym / sponsor ID
- 960061
- Conditions
- Acquired Immunodeficiency Syndrome, Alcoholism, HIV Infection, Neoplasm, Smoking
- Keywords
- Smoking, Alcohol, HIV, AIDS, DNA Markers, Personality, Healthy Volunteers, Normal Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,500 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Apr 1996
- Study completion
- Jul 2004
- First posted
- 4 Nov 1999 (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.
We propose to conduct a multifactorial genetic study of cancer risk-related behaviors and other complex human characteristics. The main areas of interest are tobacco smoking, excess alcohol consumption, psychological traits, and HIV/AIDS susceptibility and progression. The subjects will be adult male and female probands who display one or more of the phenotypes of interest together with their brothers, sisters and parents. Information on tobacco and alcohol use, psychological and personality traits, sexual behavior, HIV status and progression, and other characteristics with possible genetic components will be obtained through structured interviews and questionnaires. DNA will be prepared from blood samples and typed for a series of candidate genes chosen for function and for random polymorphic markers. By correlating the genotypic and phenotypic information, we hope to identify individual loci that interactively contribute to many different aspects of human health and disease.
Detailed description
We propose to conduct a multifactorial genetic study of cancer risk-related behaviors and other complex human characteristics. The main areas of interest are tobacco smoking, excess alcohol consumption, psychological traits, and HIV/AIDS susceptibility and progression. The subjects will be adult male and female probands who display one or more of the phenotypes of interest together with their brothers, sisters and parents. Information on tobacco and alcohol use, psychological and personality traits, sexual behavior, HIV status and progression, and other characteristics with possible genetic components will be obtained through structured interviews and questionnaires. DNA will be prepared from blood samples and typed for a series of candidate genes chosen for function and for random polymorphic markers. By correlating the genotypic and phenotypic information, we hope to identify individual loci that interactively contribute to many different aspects of human health and disease.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- The basic requirement for entry in the study will be the presence of any individual smoker who is willing to complete the evaluation process and donate a blood sample.
- Additional siblings will be encouraged but not required to participate.
- Probands will be recruited through smoking cessation programs at the National Naval Medical Center.
- Attendees at programs offered by the Health Promotions Department and the Military Family Health Center will be invited to participate in this study.
Key exclusion criteria (2 listed)
- All subjects will be adults (greater than 18 years).
- There will be no exclusions based on sex, ethnic group, or race.
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 2392895Carmelli D, Swan GE, Robinette D, Fabsitz RR. Heritability of substance use in the NAS-NRC Twin Registry. Acta Genet Med Gemellol (Roma). 1990;39(1):91-8. doi: 10.1017/s0001566000005602.
- Background: PubMed 1508241Carmelli D, Swan GE, Robinette D, Fabsitz R. Genetic influence on smoking--a study of male twins. N Engl J Med. 1992 Sep 17;327(12):829-33. doi: 10.1056/NEJM199209173271201.
- Background: PubMed 2136102Swan GE, Carmelli D, Rosenman RH, Fabsitz RR, Christian JC. Smoking and alcohol consumption in adult male twins: genetic heritability and shared environmental influences. J Subst Abuse. 1990;2(1):39-50. doi: 10.1016/s0899-3289(05)80044-6.
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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 Acquired Immunodeficiency Syndrome and Alcoholism, 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 4 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 NCT00001500, 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.