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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 January 2013 |
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Main ID: |
NCT01443468 |
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Date of registration:
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28/09/2011 |
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Primary sponsor: |
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Public title:
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Clinical and Genetic Studies of Li-Fraumeni Syndrome
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Scientific title:
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Clinical, Epidemiologic, and Genetic Studies of Li-Fraumeni Syndrome |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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5000 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01443468 |
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Study type:
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Observational |
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Study design:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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For more information at the NIH Clinical Center contact National Cancer Institute Referral Office |
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Address:
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Telephone:
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(888) NCI-1937 |
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Email:
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Affiliation:
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Name:
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Renee C Bremer |
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Address:
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Telephone:
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(301) 451-9731 |
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Email:
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bremerrc@mail.nih.gov |
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Affiliation:
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Name:
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Sharon A Savage, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Cancer Institute (NCI) |
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Key inclusion & exclusion criteria
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- INCLUSION CRITERIA:
- On referral, persons age three and up will be considered for inclusion in the study
because of either:
- A family or personal medical history of neoplasia consistent with the diagnosis of
LFS or LFL; or,
- A personal history of a germline TP53 mutation; or,
- A first- or second- degree relative of a TP53 mutation carrier, regardless of
mutation status; or,
- A personal history of three or more LFS-related primary cancers; or,
- A personal history of adrenal cortical carcinoma or choroid plexus carcinoma at any
age, regardless of family history
Personal and family medical history must be verified through questionnaires, interviews,
review of medical records and/or review of pathology slides.
There are 72 families who have previously enrolled in the pilot study under protocol
78-C-0039. As the eligibility criteria remain the same, these families will be eligible
for this protocol and will be invited to sign the new consent.
- Ability of subject or Legally Authorized Representative (LAR) to understand and the
willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
- Referred individuals and families whose reported diagnoses cannot be verified
- Medical or psychiatric disorder which, in the opinion of the Principal Investigator,
would preclude the ability to participate in clinical research
Age minimum:
3 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Li-Fraumeni Syndrome
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Neoplasms
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Tp53 Mutations
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Secondary ID(s)
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11-C-0255
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110255
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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