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NCT05350761 · National Cancer Institute (NCI)

Rare Tumors and Cancer Predisposition in Individuals and Families

What this study is about

Background: Some people may be prone to develop cancer for many reasons. Factors that affect their risk include the genes they inherit and the environment they live and work in. Researchers want to learn more about the natural history of cancer. Objective: To understand how genes and environmental factors can cause tumors and related conditions.

View original scientific description

Background: Some people may be prone to develop cancer for many reasons. Factors that affect their risk include the genes they inherit and the environment they live and work in. Researchers want to learn more about the natural history of cancer. Objective: To understand how genes and environmental factors can cause tumors and related conditions. Eligibility: People of any age who: Have tumors of an unusual type, pattern, or number Have a family member with a history of cancer Have been exposed to other factors that may increase their risk of cancer Design: This study does not involve treatment. Participants will answer questions about their personal and family medical history. They will give permission for researchers to see their medical records. Participants may be invited to the NIH Clinical Center for a physical exam. They may give samples including saliva, cheek cells, blood, urine, skin, and/or hair. Participants with cancer may give bone marrow. A needle will be used to remove a small sample of bone marrow from their hip bone. Participants may have a biopsy of their tumor. Participants may have other exams: Dental Ear, nose, and throat Eye Hearing Heart function and structure Participants with cancer may undergo more exams: A test of how much energy their body uses when resting A sleep study with a test that measures brain electrical activity. They will have sensors attached to their body while they sleep overnight in a lab. Imaging scans, such as CT, MRI, a test to measure how dense their bones are (DEXA), and ultrasound. Participants will have their genes tested. A counsellor will help them understand the results. Participants will be followed until at least 2035.

Primary outcome measures

Defining the natural history of familial cancers and susceptibility states over multiple generations, identifying cancer susceptibility genes, and assessing gene-environment and gene-gene interactions

Time frame: Ongoing

New cancer development or current health status

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • Although specific familial syndromes vary in prevalence by sex, race or ethnicity, no one is excluded from participation by sex, gender, race or ethnicity. Since families participate in studies, the sex distribution is essentially balanced, and all ages are included. Minor children below the age of assent are actively studied only when the benefits of participation outweigh the risks. Affected: An individual who meets any of the following criteria will be eligible to participate in this study:
  • Personal medical history of neoplasia of an unusual type, pattern, or number; or,
  • Known or suspected factor(s) predisposing to neoplasia, either genetic and/or congenital factors (birth defects, metabolic phenotype, chromosomal anomalies or Mendelian traits associated with tumors), environmental exposure (medications, occupation, radiation, diet, infectious agents, etc.), or unusual demographic features (very young age of onset, multiple tumors, etc.).
  • There is no age restriction; therefore including viable neonates However, children \< 3 years old will not come to the Clinical Center unless clinically indicated until they are \>= 3 years old.
  • Participant or their Legally Authorized Representative (LAR) must sign and date an IRB approved informed consent form (signed on paper or electronically for the Field Cohort / signed on paper for the Clinic Center Cohort) Unaffected Controls: An individual who meets any of the following criteria will be eligible to participate in this study:
  • Family medical history of neoplasia of an unusual type, pattern, or number; or,
  • Known or suspected factor(s) predisposing to neoplasia, either genetic and/or congenital factors (birth defects, metabolic phenotype, chromosomal anomalies or Mendelian traits associated with tumors), environmental exposure (medications, occupation, radiation, diet, infectious agents, etc.), or unusual demographic features (very young age of onset, multiple tumors, etc.).
  • There is no age restriction; therefore including viable neonates. However, children \< 3 years old will not come to the Clinical Center unless clinically indicated until they are \>= 3 years old.
  • Participant or their LAR must sign and date an IRB-approved informed consent form (signed on paper or electronically for the Field Cohort / signed on paper for the Clinic Center Cohort) Personal and family medical history will be verified through questionnaires, interviews, and review of pathology slides and medical records. For familial neoplasms, two or more living affected cases among family members are required. The types of suspected factors predisposing to neoplasia and/or familial tumors under active accrual and study will be investigator- and hypothesis-driven. This approach permits CGB investigators to remain alert to the opportunities afforded by clusters of rare tumors in families and individuals, and to be more responsive to the dynamic research priorities in cancer genetics.

Exclusion criteria

  • Affected: An individual who meets any of the following criteria will be excluded from participation in this study:
  • Referred individuals for whom reported diagnoses cannot be verified
  • Inability of the participant or LAR to understand and be willing to sign a written informed consent document.
  • Referred individuals who are eligible for other CGB protocols that are specific to a hereditary cancer syndrome (e.g., Li-Fraumeni Syndrome, Familial Melanoma) Unaffected Controls: An individual who meets any of the following criteria will be excluded from participation in this study:
  • Referred families for whom reported diagnoses cannot be verified
  • Inability of the participant or LAR to understand and be willing to sign a written informed consent document.
  • Referred families who are eligible for other CGB protocols that are specific to a hereditary cancer syndrome (e.g., Li-Fraumeni Syndrome, Familial Melanoma)

Where

  • Bethesda, Maryland
  • Rockville, Maryland

Related conditions & keywords

CancerHereditary NeoplasmsGenetic Predisposition to CancerEnvironmentGenes/GeneticsNatural History

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations

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Bethesda

Maryland

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RECRUITING

Rockville

Maryland

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What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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If you're searching for Cancer treatment in Bethesda, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Bethesda, Rockville and surrounding areas.

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Local Sites
2 locations in Maryland
Now Enrolling
Up to 500 participants
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Why Consider a Clinical Trial for Cancer?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Cancer

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Cancer Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05350761. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.