This study is currently recruiting participants.
Number
000678-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: N/A Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
None
Keywords
Cancer; Genes/Genetics; Hereditary Neoplasms; Environment; Natural History
Recruitment Keyword(s)
Condition(s)
Cancer; Hereditary Neoplasms; Genetic Predisposition to Cancer; Environment
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Cancer Institute
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.
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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)
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,
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
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)
Principal Investigator
Referral Contact
For more information: