Rare Tumors and Cancer Predisposition in Individuals and Families

Launched by NATIONAL CANCER INSTITUTE (NCI) · Apr 27, 2022

Keywords

ClinConnect Summary

This clinical trial focuses on understanding how genetics and environmental factors contribute to the development of rare tumors and cancer in individuals and families. Researchers aim to learn more about why some people are more likely to develop cancer, looking at both inherited traits and outside influences, like lifestyle and exposure to certain substances. The study is open to anyone, regardless of age or background, who has unusual tumors or a family history of cancer, or who has been exposed to potential cancer-causing factors.

Participants in this study will not receive treatment but will be asked to provide information about their health history and family medical background. They may need to visit a research center for physical exams and give samples, such as saliva or blood. Some participants might also undergo genetic testing to better understand their cancer risk. Throughout the study, participants will be supported with counseling to help them interpret their results, and they will be followed until at least 2035 to track any developments. This trial aims to gather important information that could help improve cancer prevention and treatment for future patients.

Gender

ALL

Eligibility criteria

• * 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:
• • 1. Personal medical history of neoplasia of an unusual type, pattern, or number; or,
• • 2. 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.).
• • 3. 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.
• • 4. 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:
• • 1. Family medical history of neoplasia of an unusual type, pattern, or number; or,
• • 2. 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.).
• • 3. 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.
• • 4. 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:
• • 1. Referred individuals for whom reported diagnoses cannot be verified
• • 2. Inability of the participant or LAR to understand and be willing to sign a written informed consent document.
• • 3. 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:
• • 1. Referred families for whom reported diagnoses cannot be verified
• • 2. Inability of the participant or LAR to understand and be willing to sign a written informed consent document.
• • 3. Referred families who are eligible for other CGB protocols that are specific to a hereditary cancer syndrome (e.g., Li-Fraumeni Syndrome, Familial Melanoma)