Is NCT01443468 recruiting in Bethesda, MD?

Yes, NCT01443468 is currently recruiting participants at its Bethesda, MD location. This li-fraumeni syndrome clinical trial is actively enrolling qualified participants.

How do I join the li-fraumeni syndrome clinical trial in Bethesda?

To join this clinical trial in Bethesda, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Bethesda clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Li-Fraumeni Syndrome Clinical Trial in Bethesda, MD

About This Li-Fraumeni Syndrome Study in Bethesda

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 monitored for several years, with regular followup visits to the National Institutes of Health, if indicated. Any changes in health or cancer status will be recorded.

Sponsor: National Cancer Institute (NCI)

Who Can Participate

Inclusion Criteria

On referral, persons of all ages 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. For both the Field and Clinical Center Cohort, the PI will ensure that study investigators will identify an appropriate LAR consistent with requirements of Policy 403 and will obtain consent from the LAR as outlined in the consent process before initiating research interventions. -Pregnant women In order to study the lifetime rates of cancer development in all individuals with Li-Fraumeni syndrome, we will need to evaluate what effect pregnancy may have on rate of cancer development both in affected individuals and unaffected family controls. Additionally, some cancers are known to have an increased risk of development in the context of pregnancy and lactation.

Exclusion Criteria

of pregnant women would preclude understanding of these cancer risks for an important subset of the population. Pregnant women are eligible for enrollment on the data collection component of this study. Pregnant women will be included in this study as several endpoints may be assessed during pregnancy; counseling, education, and other minimal risk procedures (i.e. blood draw) may be done. We will postpone full clinical evaluations at the Clinical Center of pregnant women until the subject has recovered post-partum. All screening studies, for women who are pregnant, or breastfeeding will be deferred while the woman is pregnant or breastfeeding. Pregnancy testing will be performed for females of childbearing age prior to imaging studies, and the test results must be negative prior to the scan.. The risk to the fetus and pregnant woman would be no greater than minimal for procedures that are performed. 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

Women who are pregnant will not be eligible for the cancer screening protocol until they recover post-partum. Women participating in the cancer screening protocol will discontinue this component if they become pregnant while on study. Once they recover post-partum, they can continue the cancer screening protocol.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT01443468) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Li-Fraumeni Syndrome Treatment Options in Bethesda, MD

If you're searching for li-fraumeni syndrome treatment options in Bethesda, MD, this clinical trial (NCT01443468) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this clinical trial. You'll receive care from experienced li-fraumeni syndrome specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all li-fraumeni syndrome clinical trials near you to find additional studies recruiting in your area.

Li-Fraumeni Syndrome Clinical Trial in Bethesda, MD

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