Molecular Basis for Variations in Hereditary Colorectal Cancer Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Variations in Clinical Features Compared Between Proband Group and Family Member Group
研究概览
简要总结
Objectives:
- To examine the variations in clinical features, survival outcomes, family history, and health behavior among proband patients who are known or suspected to have a hereditary colorectal cancer syndrome
- To compare the clinical features, survival outcomes, and health behavior of the proband vs. his/her family members who may or may not be affected by the hereditary colorectal cancer syndrome
- To explore for correlations between germline genetic variations in both the probands and family members with observed variations in the overall disease phenotype across probands and kindreds, within a given syndrome. Disease phenotype is defined to include: (1) clinicopathologic features including patient demographics and oncologic outcomes; (2) clinical manifestations of disease including the timing, spectrum and severity of CRC and extracolonic cancers. Genetic variations may include the specific codon mutated, the type of mutation and sequence alteration (e.g. nonsense, missense etc), chromosomal/gene copy number changes, and gene polymorphisms.
- To explore for correlations between germline genetic variations in both the probands and family members with observed variations in somatic CRC tumor biology, including tumor pathology and other tumor molecular markers
详细描述
Participants:
Questionnaires:
If participant agrees to take part in this study, participant will fill out a some questionnaires about participant's work, family history, medical history, and health habits. If participant has already answered these questionnaires when participant was registered as a patient at MD Anderson, the study staff will give participant a copy and review participant's answers with participant for any updates or if participant has any questions. It should take about 20 minutes to complete the questionnaires.
Participant will also complete a health and lifestyle questionnaire, which contains 20 questions for men and 22 questions for women. This questionnaire should take about 10 minutes to complete.
Participant may be given the questionnaires electronically on REDcap (a secure, web-based application used to collect data for research studies that participant can access from participant's phone, tablet, or computer), over the phone (either with a member of the study staff asking questions or by using an electronic response system called IVR), at home through the mail, or in person by a member of the research staff at participant's MD Anderson visit. If mailed, a postage-paid return envelope will be provided for the return of the questionnaire.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Probands who meet the following criteria will be eligible:
- •Patient must have or is suspected to have a hereditary CRC syndrome
- •Patient must be at least 18 years of age at the time of study registration.
- •Patient must have sufficient command of the English language and mental capacity to provide consent
- •Family members who meet the following criteria will be eligible:
- •First- or second-degree relative of a registered MDACC patient who has met eligibility criteria for a Proband as defined above.
- •Family member must be at least 18 years of age at the time of study registration.
- •Family member must have sufficient command of the English language and mental capacity to provide consent
排除标准
- 未提供
研究组 & 干预措施
Family Members (Not MDA Registered Patients) Group
Health questionnaire completed at baseline. Blood sample taken at baseline. Follow-up questionnaire completed at least 1 time in 5 years.
干预措施: Blood Draw/Saliva Sample (Procedure)
Family Members (Not MDA Registered Patients) Group
Health questionnaire completed at baseline. Blood sample taken at baseline. Follow-up questionnaire completed at least 1 time in 5 years.
干预措施: Questionnaires (Behavioral)
Family Members (MDA Registered Patients) Group
Health questionnaire completed at baseline. Blood sample taken at baseline. Follow-up questionnaire completed at least 1 time in 5 years.
干预措施: Questionnaires (Behavioral)
Family Members (MDA Registered Patients) Group
Health questionnaire completed at baseline. Blood sample taken at baseline. Follow-up questionnaire completed at least 1 time in 5 years.
干预措施: Blood Draw/Saliva Sample (Procedure)
Consenting Proband Group
Questionnaires completed at baseline. Blood sample taken at baseline. Follow-up questionnaire completed at least 1 time in 5 years.
干预措施: Blood Draw/Saliva Sample (Procedure)
Consenting Proband Group
Questionnaires completed at baseline. Blood sample taken at baseline. Follow-up questionnaire completed at least 1 time in 5 years.
干预措施: Questionnaires (Behavioral)
结局指标
主要结局
Variations in Clinical Features Compared Between Proband Group and Family Member Group
时间窗: 5 years
Comparison made using 1-way ANOVA or Chi-squared tests.
次要结局
- Variations in the Overall Disease Phenotype Between Proband Group and Family Member Group(5 years)