Non-cancer Affected VolunteersNCT00579618
Ascertainment of Saliva or Blood Samples For Genetic Epidemiology Studies of Cancer and Aging
An observational study of Non-cancer Affected Volunteers, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to help us learn more about the roles of genes in cancers. Genes are short pieces of DNA which determine the inherited characteristics that distinguish one individual from another. This study will look at how some genes might raise or lower the chance some people may develop cancer. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-cancer Affected Volunteers
- What is being tested?
- Saliva or Blood samples
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jul 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Nursing homes, senior centers, health fairs or other community organizations.
Who may be able to join
- Eligible subjects must be non-cancer affected volunteers of either gender who are 60 years of age or older at the time of saliva/blood donation.
- Subjects will self-identify religion and country of origin of grandparents.
- Volunteers will have (by self report) no history of cancer other than nonmelanoma skin cancer. It is recognized that there may be some errors in self report, however, the literature reports a very low error rate for self reported disease reporting for cancer as assessed by interview.
Who cannot join
- Subjects with mental impairment will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to help us learn more about the roles of genes in cancers. Genes are short pieces of DNA which determine the inherited characteristics that distinguish one individual from another. This study will look at how some genes might raise or lower the chance some people may develop cancer. The sample collection will help generate the materials needed for this study.
Read the detailed description
This is a protocol to obtain saliva or blood samples from non-cancer affected volunteers aged 60 years or older, without a history of cancer other than non-melanoma skin cancer. These samples will be used in a genomic approach to elucidate novel pathways of cancer predisposition.
- Conditions
- Non-cancer Affected Volunteers
- Being tested
- Saliva or Blood samples
- Keywords
- non-cancer affected volunteers, aged 60 years or older
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva or Blood samplesOther
Extracting sample of saliva or blood only once.
What is being measured
The primary outcome is the main question the study is designed to answer.
obtain saliva or blood from non-cancer volunteers, 60 years or older to carry out anonymous genetic epidemiology studies related to resistance to cancer in elderly.
Measured: conclusion of the study
Secondary outcomes (1)
samples perform high density genomic scans & candid gene studies carriers specif BRCA found mutat who haven't been affect by breast cancer & old than 60 find genetic cofactor may modify a predispo breast ca confer by germline mutation in BRCA1 & BRCA2.
Measured: conclusion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startSep 2006
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-cancer Affected VolunteersStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation, Beth Abraham, Gurwin Jewish Nursing & Rehabilitation Center, Hebrew Home at Riverdale, Jewish Home & Hospital Lifecare System, Margaret Tietz Nursing and Rehabilitation Center, Metropolitan Jewish Health System, Northern Services Group, Parker Jewish Institute, Lenox Hill Neighborhood House, JASA at Temple Emanuel of Parkchester Senior Center, Van Cortlandt Village Senior Center
- Responsible party
- Sponsor
- Investigators
- Kenneth Offit, MD, MPH, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579618
- Sponsor's protocol ID
- 06-102
- Status last verified
- Jul 2017
- First submitted
- 20 Dec 2007
- Last updated
- 31 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ascertainment of Saliva or Blood Samples For Genetic Epidemiology Studies of Cancer and Aging
- ClinicalTrials.gov ID
- NCT00579618
- Acronym / sponsor ID
- 06-102
- Conditions
- Non-cancer Affected Volunteers
- Keywords
- non-cancer affected volunteers, aged 60 years or older
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation, Beth Abraham, Gurwin Jewish Nursing & Rehabilitation Center, Hebrew Home at Riverdale, Jewish Home & Hospital Lifecare System, Margaret Tietz Nursing and Rehabilitation Center, Metropolitan Jewish Health System, Northern Services Group, Parker Jewish Institute, Lenox Hill Neighborhood House, JASA at Temple Emanuel of Parkchester Senior Center, Van Cortlandt Village Senior Center
- Study start
- Sep 2006 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 24 Dec 2007 (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.
The purpose of this study is to help us learn more about the roles of genes in cancers. Genes are short pieces of DNA which determine the inherited characteristics that distinguish one individual from another. This study will look at how some genes might raise or lower the chance some people may develop cancer. The sample collection will help generate the materials needed for this study.
Detailed description
This is a protocol to obtain saliva or blood samples from non-cancer affected volunteers aged 60 years or older, without a history of cancer other than non-melanoma skin cancer. These samples will be used in a genomic approach to elucidate novel pathways of cancer predisposition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Nursing homes, senior centers, health fairs or other community organizations.
Key inclusion criteria (3 listed)
- Eligible subjects must be non-cancer affected volunteers of either gender who are 60 years of age or older at the time of saliva/blood donation.
- Subjects will self-identify religion and country of origin of grandparents.
- Volunteers will have (by self report) no history of cancer other than nonmelanoma skin cancer. It is recognized that there may be some errors in self report, however, the literature reports a very low error rate for self reported disease reporting for cancer as assessed by interview.
Key exclusion criteria (1 listed)
- Subjects with mental impairment will be excluded from this study.
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 |
|---|---|---|
| Saliva or Blood samplesExtracting sample of saliva or blood only once. | Other | – |
Primary outcome
obtain saliva or blood from non-cancer volunteers, 60 years or older to carry out anonymous genetic epidemiology studies related to resistance to cancer in elderly.
Time frame: conclusion of the study
1 secondary outcome
samples perform high density genomic scans & candid gene studies carriers specif BRCA found mutat who haven't been affect by breast cancer & old than 60 find genetic cofactor may modify a predispo breast ca confer by germline mutation in BRCA1 & BRCA2.
Time frame: conclusion of the study
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 31 Jul 2017.
- Memorial Sloan Kettering Web SiteLink provided by the sponsor.
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.
Kenneth Offit, MD, MPH principal investigator
Memorial Sloan Kettering Cancer Center
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 Non-cancer Affected Volunteers, run by Memorial Sloan Kettering Cancer Center 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 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 31 Jul 2017. 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.
What does the primary outcome measure?
obtain saliva or blood from non-cancer volunteers, 60 years or older to carry out anonymous genetic epidemiology studies related to resistance to cancer in elderly. (time frame: conclusion of the study). 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 31 Jul 2017.