Clinical and Genetic Studies in Familial Non-Medullary Thyroid Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- To evaluate the natural history of FNMTC
研究概览
简要总结
Background:
- Researchers are studying types of thyroid cancer that seem to cluster in families. Non-medullary thyroid cancer accounts for the vast majority of all types of thyroid cancer, but little is known about possible genes that may cause the cancer. More research is needed to develop the best ways to screen for familial non-medullary thyroid cancer (FNMTC) so that it can be diagnosed and treated at an early stage.
Objectives:
- To evaluate the natural history of FNMTC.
- To determine the best screening strategy for FNMTC.
- To identify genes that may indicate susceptibility to FNMTC.
Eligibility:
- Individuals at least 7 years of age who have two first-degree relatives (e.g., parents, children, siblings) who have or have had non-medullary thyroid cancer or a documented diagnosis of non-medullary thyroid cancer and one living relative with documented non-medullary thyroid cancer.
Design:
- Participants will be evaluated by family history pedigree, physical examination, imaging (including possible neck ultrasound and radioactive iodine scans), and laboratory testing.
- Participants who agree to have blood or other biological samples collected will be asked to enroll in an additional study to provide the appropriate samples and tissues.
- After the initial study evaluation, participants who are not found to have a malignant thyroid tumor will be re-screened every year with non-invasive imaging studies. Participants who are found to have a malignant thyroid tumor will be informed of possible treatment options.
详细描述
Study Description:
This is a prospective cohort study of individuals with or at risk for non-medullary thyroid cancer. Individuals will be studied over time within the context of their families in order to quantify prospective risks of cancers in family members, to establish the natural history of FNMTC, define the spectrum of diseases within the families, to identify precursor states, to try to assess the contribution of genetic and environmental components of risk, and to develop effective screening strategies.
Objectives:
- To evaluate the natural history of familial non-medullary thyroid cancer (FNMTC).
- To determine the best screening strategy for FNMTC.
- To identify susceptibility gene(s) for FNMTC.
Endpoints:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •Subjects will be selected for this protocol based on either a clinical diagnosis of non-medullary thyroid cancer and the presence of one family member with the disease or the presence of 2 living family members with this disease. Patient selection for this protocol will not be based on gender, race, or ethnic background.
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Adults or minor (>= 7 years+), males and females.
- •An unaffected individual with (Bullet) 2 first-degree relatives who have or have had nonmedullary thyroid cancer
- •An affected individual with documented diagnosis of non-medullary thyroid cancer and (Bullet) one living relative with documented non-medullary thyroid cancer (Note: as this is a familial study, subjects do not need to present with the disease)
- •Any member of an affected family. (Note: for this study, an affected family is defined as a family having 2 or more 1st degree relatives with a documented diagnosis of FNMTC.)
- •Adults must be able to understand and the willingness to sign the informed consent document.
- •Adults must be able to complete the family history questionnaire.
排除标准
- •An individual who meets any of the following criteria will be not be allowed to enroll in this study:
- •Subjects unwilling/unable to give informed consent.
研究组 & 干预措施
2/ Cohort 2
Non-affected members of families with non-medullary thyroid cancer
1/ Cohort 1
Affected with non-medullary thyroid cancer
结局指标
主要结局
To evaluate the natural history of FNMTC
时间窗: end of study
Evaluation the natural history of FNMTC
次要结局
未报告次要终点