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Genetic Study of Young Patients With Colorectal Cancer

2016年7月1日 更新者：Alliance for Clinical Trials in Oncology

A Prospective Study Of The Prognostic Significance Of Microsatellite Instability In Patients With Early Age-Of-Onset Colorectal Cancer

RATIONALE: Identifying gene mutations (microsatellite instability) may allow doctors to plan effective treatment for patients who develop colorectal cancer at an early age.

PURPOSE: Genetic trial to determine the significance of gene mutations in helping predict the outcome of treatment in patients who develop stage I, stage II, or stage III colorectal cancer at an early age.

研究概览

地位

完全的

条件

干预/治疗

详细说明

OBJECTIVES:

  • Evaluate the prognostic significance (e.g., overall survival) of microsatellite instability (MSI) status in patients with early age-of-onset stage I-III colorectal cancer, assuming the presence of a quantitative interaction between MSI status and family history of cancer.
  • Evaluate the development of metachronous neoplasms in this patient population.
  • Evaluate the histologic features and genetic changes associated with hereditary nonpolyposis colorectal cancer in this patient population.

OUTLINE: This is a multicenter study. Patients are stratified according to family history using the Amsterdam II criteria for hereditary nonpolyposis colorectal cancer (positive vs negative).

Patients undergo baseline colonoscopy before or within 6 months of initial curative resection and then surveillance colonoscopy at 1, 3, and 5 years (+/- 6 months) after resection. The number, size, location, histology, and method of removal of polyps are documented at the time of colonoscopy. Patients also undergo microsatellite instability (MSI) status testing and complete family history questionnaires at baseline.

The prognostic significance of family history and MSI status is evaluated. The individual histologic features of the tumors are compared with the MSI status to determine their predictive value. The histologic features are also correlated with outcome to determine their prognostic significance.

Patients may be referred for genetic counseling.

A certificate of confidentiality protecting the identity of research participants in this project has been issued by the National Cancer Institute.

研究类型

观察性的

注册 (实际的)

651

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
    • Ontario
      • Thunder Bay、Ontario、加拿大、P7B 6V4
        • Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
      • Toronto、Ontario、加拿大、M4N 3M5
        • Toronto Sunnybrook Regional Cancer Centre
  • 美国
    • Alabama
      • Mobile、Alabama、美国、36640-0460
        • Mobile Infirmary Medical Center
      • Mobile、Alabama、美国、36608
        • Providence Cancer Center
    • California
      • Colton、California、美国、92324-1819
        • Arrowhead Regional Medical Center
      • Duarte、California、美国、91010-3000
        • City of Hope Comprehensive Cancer Center
      • San Francisco、California、美国、94115
        • UCSF Comprehensive Cancer Center
    • Florida
      • Clearwater、Florida、美国、33756
        • Morton Plant Hospital
      • Fort Lauderdale、Florida、美国、33308
        • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
      • Gainesville、Florida、美国、32610-100277
        • Shands Cancer Center at the University of Florida Health Science Center
      • Tampa、Florida、美国、33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Gainesville、Georgia、美国、30501
        • Surgical Oncology of Northeast Georgia
    • Illinois
      • Arlington Heights、Illinois、美国、60005
        • Northwest Community Hospital
      • Aurora、Illinois、美国、60504-4206
        • Rush Copley Medical Center
      • Chicago、Illinois、美国、60637-1470
        • University of Chicago Cancer Research Center
      • Chicago、Illinois、美国、60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
      • Maywood、Illinois、美国、60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
    • Indiana
      • Indianapolis、Indiana、美国、46202
        • Indiana University Cancer Center
    • Iowa
      • Des Moines、Iowa、美国、50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Iowa City、Iowa、美国、52242-1009
        • Holden Comprehensive Cancer Center at University of Iowa
    • Kentucky
      • Lexington、Kentucky、美国、40503-9985
        • Central Baptist Hospital
    • Louisiana
      • New Orleans、Louisiana、美国、70121
        • Ochsner Clinic Foundation
      • Shreveport、Louisiana、美国、71130-3932
        • Louisiana State University Health Sciences Center - Shreveport
    • Maryland
      • Baltimore、Maryland、美国、21201
        • Greenebaum Cancer Center at University of Maryland Medical Center
      • Baltimore、Maryland、美国、21229
        • St. Agnes Cancer Center
    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • Brigham and Women's Hospital
      • Burlington、Massachusetts、美国、01805
        • Lahey Clinic Medical Center - Burlington
      • Worcester、Massachusetts、美国、01655
        • UMASS Memorial Cancer Center - University Campus
    • Michigan
      • Flint、Michigan、美国、48532
        • Great Lakes Cancer Institute - McLaren
    • Minnesota
      • Minneapolis、Minnesota、美国、55455
        • University of Minnesota Cancer Center
    • Mississippi
      • Tupelo、Mississippi、美国、38801
        • Digestive Health Specialists, P.A.
    • Missouri
      • Columbia、Missouri、美国、65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Saint Louis、Missouri、美国、63110
        • Siteman Cancer Center at Barnes-Jewish Hospital
    • Nebraska
      • Omaha、Nebraska、美国、68114-4199
        • Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
      • Omaha、Nebraska、美国、68131-2197
        • Cancer Center at Creighton University Medical Center
    • New York
      • New York、New York、美国、10021
        • Memorial Sloan-Kettering Cancer Center
      • Rochester、New York、美国、14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
    • North Carolina
      • Charlotte、North Carolina、美国、28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Charlotte、North Carolina、美国、28204
        • Presbyterian Hospital
      • Durham、North Carolina、美国、27710
        • Duke Comprehensive Cancer Center
      • Winston-Salem、North Carolina、美国、27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • Ohio
      • Akron、Ohio、美国、44302
        • Akron General's McDowell Cancer Center
      • Cleveland、Ohio、美国、44195
        • Cleveland Clinic Taussig Cancer Center
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73112
        • Integris Oncology Services
      • Tulsa、Oklahoma、美国、74136
        • Natalie Warren Bryant Cancer Center
    • Pennsylvania
      • Abington、Pennsylvania、美国、19001
        • Abington Memorial Hospital
      • Philadelphia、Pennsylvania、美国、19104-4283
        • Abramson Cancer Center of the University of Pennsylvania
      • Philadelphia、Pennsylvania、美国、19107-5541
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Pittsburgh、Pennsylvania、美国、15224
        • Western Pennsylvania Hospital
      • Pittsburgh、Pennsylvania、美国、15212-4772
        • Allegheny General Hospital
      • Pittsburgh、Pennsylvania、美国、15213
        • UPMC Cancer Center at Magee-Womens Hospital
    • Tennessee
      • Chattanooga、Tennessee、美国、37404-3285
        • Sarah Cannon Cancer Center at Parkridge Medical Center
      • Memphis、Tennessee、美国、38120
        • Baptist Cancer Institute at Baptist Memorial Hospital - Memphis
      • Nashville、Tennessee、美国、37236
        • Baptist Hospital
      • Nashville、Tennessee、美国、37232-6860
        • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
    • Texas
      • Dallas、Texas、美国、75246
        • Baylor University Medical Center
      • Dallas、Texas、美国、75231
        • Presbyterian Hospital of Dallas
      • Houston、Texas、美国、77030-4009
        • University of Texas - MD Anderson Cancer Center
      • Houston、Texas、美国、77030
        • Methodist Hospital
    • Utah
      • Salt Lake City、Utah、美国、84132
        • Huntsman Cancer Institute
    • Vermont
      • Burlington、Vermont、美国、05401
        • Fletcher Allen Health Care - Medical Center Campus
    • Virginia
      • Fairfax、Virginia、美国、22033
        • Inova Fair Oaks Hospital
      • Falls Church、Virginia、美国、22042-3300
        • INOVA Fairfax Hospital
      • Richmond、Virginia、美国、23298-0037
        • Massey Cancer Center at Virginia Commonwealth University
    • Washington
      • Spokane、Washington、美国、99210-0248
        • Deaconess Medical Center
      • Spokane、Washington、美国、99204
        • Sacred Heart Medical Center
      • Spokane、Washington、美国、99204
        • Associated Surgeons P.S.
      • Spokane、Washington、美国、99208
        • Providence Cancer Center at Holy Family Hospital
    • Wisconsin
      • Appleton、Wisconsin、美国、54911
        • Appleton Medical Center
      • Appleton、Wisconsin、美国、54911-3454
        • Fox Valley Surgical Associates at Appleton Medical Center
      • Madison、Wisconsin、美国、53792-7375
        • University of Wisconsin Comprehensive Cancer Center
      • Milwaukee、Wisconsin、美国、53226
        • Medical College of Wisconsin Cancer Center
      • Milwaukee、Wisconsin、美国、53226
        • Froedtert Memorial Lutheran Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 49年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients diagnosed with adenocarcinoma of the colon or rectum.

描述

DISEASE CHARACTERISTICS:

  • Diagnosis of stage I-III adenocarcinoma of the colon or rectum

  • Must have undergone an initial curative resection within the past year

    • No colon or rectal cancer resection that does not allow for definitive T or N staging
    • No initial post-surgical surveillance colonoscopy prior to study entry
  • Must have a pathology specimen, with representative normal and tumor tissues, available for submission to the ACOSOG Central Specimen Bank prior to study entry
  • No personal or family history of familial adenomatous polyposis
  • No recurrent colorectal cancer

PATIENT CHARACTERISTICS:

Age

  • 18 to 49 at first diagnosis

Other

  • Must be willing to provide a family cancer history to the study team and continue with follow-up colonoscopic surveillance
  • No other malignancy within the past 5 years except completely resected cervical cancer or nonmelanoma skin cancer
  • No evidence of recurrence of other prior malignancy

PRIOR CONCURRENT THERAPY:

Radiotherapy

  • No prior pelvic radiotherapy for rectal cancer
  • No concurrent preoperative pelvic radiotherapy for rectal cancer

Surgery

  • See Disease Characteristics

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Group 1

Patients undergo baseline colonoscopy before or within 6 months of initial curative resection and then surveillance colonoscopy at 1, 3, and 5 years (+/- 6 months) after resection. The number, size, location, histology, and method of removal of polyps are documented at the time of colonoscopy. Patients also undergo microsatellite instability (MSI) status testing and complete family history questionnaires at baseline.

The prognostic significance of family history and MSI status is evaluated. The individual histologic features of the tumors are compared with the MSI status to determine their predictive value. The histologic features are also correlated with outcome to determine their prognostic significance.

Patients may be referred for genetic counseling.
遗传的：微卫星不稳定性分析

研究衡量的是什么？

主要结果指标

结果测量
大体时间
总生存期
大体时间：长达 2 年
长达 2 年

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Alliance for Clinical Trials in Oncology

合作者

National Cancer Institute (NCI)

调查人员

  • 学习椅：Jose G. Guillem, MD、Memorial Sloan Kettering Cancer Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2002年5月1日

初级完成 (实际的)

2004年12月1日

研究完成 (实际的)

2004年12月1日

研究注册日期

首次提交

2002年9月6日

首先提交符合 QC 标准的

2003年1月26日

首次发布 (估计)

2003年1月27日

研究记录更新

最后更新发布 (估计)

2016年7月6日

上次提交的符合 QC 标准的更新

2016年7月1日

最后验证

2016年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ACOSOG-Z0190
  • CDR0000069465 (注册表标识符：NCI Physician Data Query)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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