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NCT01443468 · ClinicalTrials.gov registry record
Clinical and Genetic Studies of Li-Fraumeni Syndrome
A clinical trial of Neoplasms and Li-Fraumeni Syndrome, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- 5,000
- Enrollment target
- 2
- Study locations
NCT01443468: Recruiting study of Neoplasms and Li-Fraumeni Syndrome, sponsored by National Cancer Institute (NCI).
NCT01443468 is a study of Neoplasms and Li-Fraumeni Syndrome that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 5,000 participants, above the 1,590-participant average among 158 other Neoplasms trials with a reported enrollment target (214% higher). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01443468, a study of Neoplasms and Li-Fraumeni Syndrome, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- 5,000 participants
- Enrollment target
- 2
- Study locations
Study Summary
Background: \- Li-Fraumeni syndrome (LFS) is a genetic condition that increases the risk for some types of cancer. LFS may lead to cancer of the bone or connective tissue, breast, and brain. It may also increase the risk for certain types of leukemia and other cancers. The only known cause of LFS is a change (called a mutation ) in a gene known as TP53. However, not all people with LFS have a TP53 mutation. Researchers want to study other possible genetic causes of LFS, and factors that may increase or decrease cancer risk in people with the syndrome. Objectives: * To learn more about the types of cancers that occur in individuals with LFS. * To study the role of the TP53 gene in the development of cancer. * To look for other possible genes that cause LFS * To study the effect of LFS diagnosis on families. * To determine if environmental factors or other genes can change a person s cancer risk associated with LFS. Eligibility: * Individuals with a family or personal medical history of cancers consistent with LFS. * Individuals with a family or personal medical history of cancers that does not meet the diagnosis of LFS, but the history is suggestive for LFS (meets the diagnosis for the so-called Li-Fraumeni like syndrome) * Individuals with certain rare cancers * Individuals with a family or personal history of a TP53 gene mutation, with or without related cancer(s). Design: * Participants will fill out a medical history questionnaire and a family history questionnaire. * Blood samples will be collected for DNA and for storage. Cheek cell samples may be collected if blood cannot be obtained for DNA. Participants can choose to have or not have cancer screening with blood tests, imaging studies, and other exams. * Participants will complete questionnaires about their worries about cancer, stress levels, and coping strategies. Diet and physical activity questionnaires will also be given. Other psychological tests may be given as needed. * Participants will be mon
Primary Outcome
Learn more about the types of cancers that occur in individuals with LFS and the age at which these cancers are usually found
Conditions Studied
Study Locations (2)
Maryland
- National Cancer Institute - Shady Grove - Bethesda
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,000 participants |
| Start Date | 2012-01-17 |
What NCT01443468 shows while recruiting
NCT01443468 is an observational study that tracks outcomes without assigning an intervention. Its 5,000 participants enrollment target places it among the larger protocols in the corpus, above the 1,590-participant average among 158 other Neoplasms trials with a reported enrollment target (214% higher).
The record links to 3 conditions, with Neoplasms appearing as the primary indexed condition, and to 0 interventions.
NCT01443468 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01443468 about?
NCT01443468 is a clinical study titled "Clinical and Genetic Studies of Li-Fraumeni Syndrome". Background: \- Li-Fraumeni syndrome (LFS) is a genetic condition that increases the risk for some types of cancer. LFS may lead to cancer of the bone or connective tissue, breast, and brain. It may also increase the risk for certain types of leukemia and other cancers. The only known cause of LFS i...
What is the current status of trial NCT01443468?
This trial is currently recruiting. The enrollment target is 5,000 participants. The study started on 2012-01-17.
What conditions does trial NCT01443468 study?
This clinical trial studies the following conditions: Neoplasms, Li-Fraumeni Syndrome, Tp53 Mutations.
Who is sponsoring clinical trial NCT01443468?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01443468 being conducted?
This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01443468's enrollment target sits among peer trials
5,000 6th of 158 higher than 152 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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