NCT00579618

Brief 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. The sample collection will help generate the materials needed for this study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2007

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 31, 2017

Status Verified

July 1, 2017

Enrollment Period

10.8 years

First QC Date

December 20, 2007

Last Update Submit

July 28, 2017

Conditions

Keywords

non-cancer affected volunteersaged 60 years or older

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    conclusion of the study

Interventions

Extracting sample of saliva or blood only once.

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Nursing homes, senior centers, health fairs or other community organizations.

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects with mental impairment will be excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Saliva or blood samples

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Kenneth Offit, MD, MPH

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 24, 2007

Study Start

September 1, 2006

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 31, 2017

Record last verified: 2017-07

Locations