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临床试验/NCT01850654
NCT01850654已完成不适用

Ohio Colorectal Cancer Prevention Initiative: Universal Screening for Lynch Syndrome

Ohio State University Comprehensive Cancer Center90 个研究点 分布在 1 个国家目标入组 3,470 人开始时间: 2012年12月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
3,470
试验地点
90
主要终点
Determine the Incidence of Hereditary Cancer Syndromes among Newly Diagnosed Colorectal Cancer Patients

研究概览

简要总结

The purpose of the Ohio Colorectal Cancer Prevention Initiative (OCCPI) is to reduce morbidity and mortality due to colorectal cancer (CRC) in the state of Ohio. By identifying individuals at high-risk for CRC (genetically predisposed) and providing screening recommendations for cancer risk reduction, the OCCPI will understand how to increase length of life and quality of life for those diagnosed with CRC in Ohio, as well as to better prevent CRC in others in Ohio.

Participants will have free tumor screening for Lynch syndrome, and may be eligible for free genetic testing and free genetic counseling as part of this study.

详细描述

Lynch Syndrome:

Lynch syndrome (LS), previously known as "hereditary non-polyposis colorectal cancer", is a hereditary cancer syndrome that causes the majority of hereditary CRC and approximately 3% of all CRC. LS significantly increases the risk for an individual to develop CRC during their lifetime. Individuals with LS also have an increased risk to develop extracolonic cancers, including endometrial, gastric, ovarian, upper urinary tract, small bowel, biliary tract, CNS, and certain types of skin cancer. Tumor studies, including microsatellite instability (MSI) testing and immunohistochemical (IHC) analysis, provide information regarding characteristic features of LS-associated tumors and can help target genetic testing. Given the hereditary nature of this syndrome, screening all patients who are newly diagnosed with CRC for LS can identify additional individuals who are at high-risk of developing cancer.

Study Aims:

By developing a CRC research infrastructure within the state of Ohio, the OCCPI will achieve the following specific aims:

  • Establish and implement a statewide universal screening protocol for LS.
  • Elucidate the prevalence of hereditary CRC in Ohio.
  • Provide screening recommendations for high-risk individuals with CRC and their families, as well as local access to genetic counseling.
  • Create a CRC biorepository for future research on the etiology of CRC from the leftover samples of the CRC patients, as well as samples from their relatives.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Newly diagnosed with colorectal adenocarcinoma (all stages) and have a resection at any hospital in Ohio between 1/1/2013 and 12/31/
  • For individuals who have neoadjuvant treatment and show a complete response at resection, the tumor screening will be attempted on their original biopsy (even if it occurred in 2012) as long as their resection occurred between 1/1/2013 and 12/31/
  • Many individuals with stage IV CRC will not have a resection; therefore, the tumor screening will be attempted on their original colon biopsy as long as their primary diagnosis occurred between 1/1/2013 and 12/31/
  • If only metastatic CRC is available on a biopsy (liver or lymph node metastases), tumor screening will be attempted on the metastatic tissue.
  • Newly diagnosed with endometrial cancer (any histology except sarcoma) and have a resection between 1/1/2013 and 12/31/2016 at OSU only.
  • All at-risk relatives of the participants found to have LS.
  • First-degree relatives (parents, siblings and adult children ≥ 25 years of age) of the CRC participants who do not have LS.

排除标准

  • Individuals who are under the age of
  • Individuals must have a primary colorectal or endometrial cancer, not a recurrence of a previous colorectal or endometrial cancer.

研究组 & 干预措施

Probands

Other

Participants with colorectal or endometrial cancer.

干预措施: Genetic testing (Genetic)

Probands

Other

Participants with colorectal or endometrial cancer.

干预措施: LS tumor screening (Genetic)

Probands

Other

Participants with colorectal or endometrial cancer.

干预措施: Genetic Counseling (Behavioral)

Probands

Other

Participants with colorectal or endometrial cancer.

干预措施: Biorepository (Other)

Probands

Other

Participants with colorectal or endometrial cancer.

干预措施: Questionnaire (Behavioral)

First-degree relatives of the participants with CRC

Other

The first-degree relatives of the CRC probands (participants with colorectal cancer).

干预措施: Biorepository (Other)

First-degree relatives of the participants with CRC

Other

The first-degree relatives of the CRC probands (participants with colorectal cancer).

干预措施: Questionnaire (Behavioral)

At-risk relatives

Other

The relatives of the participants found to have Lynch syndrome.

干预措施: Genetic testing (Genetic)

At-risk relatives

Other

The relatives of the participants found to have Lynch syndrome.

干预措施: Genetic Counseling (Behavioral)

At-risk relatives

Other

The relatives of the participants found to have Lynch syndrome.

干预措施: Biorepository (Other)

At-risk relatives

Other

The relatives of the participants found to have Lynch syndrome.

干预措施: Questionnaire (Behavioral)

结局指标

主要结局

Determine the Incidence of Hereditary Cancer Syndromes among Newly Diagnosed Colorectal Cancer Patients

时间窗: 36 months (initial assessment)

Through tumor testing for Lynch syndrome and follow-up genetic testing for all patients with abnormal tumor testing and select patients with normal tumor testing (those diagnosed under age 50 and those at or over age 50 with a first degree relative with colorectal or endometrial cancer or synchronous or metachronous colon or endometrial cancer).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heather Hampel

Principal Investigator

Ohio State University Comprehensive Cancer Center

研究点 (90)

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