Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy
2016年7月1日 更新者：Alliance for Clinical Trials in Oncology
A Pharmacogenetic Case-Control Study of Severe Diarrhea and Life-Threatening Neutropenia in Patients Treated With Irinotecan, 5-Fluorouracil and Leucovorin
RATIONALE: Genetic testing may help predict how patients will respond to chemotherapy drugs and may help doctors plan more effective treatment with fewer side effects.
PURPOSE: Genetic study to determine how genes affect the severity of diarrhea in patients with stage III colon cancer who are receiving chemotherapy.
研究概览
详细说明
OBJECTIVES:
- Determine whether the presence of a 7 allele at the UGT1A1 locus is associated with either grade 3-4 diarrhea or grade 4 neutropenia in patients with stage III colon cancer after treatment with irinotecan, fluorouracil, and leucovorin calcium.
- Determine whether polymorphisms in the TS enhancer and/or MTHFR gene are associated with grade 3-4 diarrhea in these patients after treatment with fluorouracil and leucovorin calcium.
- Determine whether polymorphisms in UGT1A1, TS, MTHFR, CYP3A4, or CYP3A5 are associated with either grade 3-4 diarrhea or grade 4 neutropenia in these patients after treatment with irinotecan, fluorouracil, and leucovorin calcium.
OUTLINE: Patients are stratified according to prior therapy (irinotecan, fluorouracil, and leucovorin calcium vs fluorouracil and leucovorin calcium) and prior toxic effects (grade 3-4 diarrhea vs grade 4 neutropenia vs grade 1 or lower diarrhea AND grade 2 or lower neutropenia).
Patients undergo collection of blood specimens for polymerase chain reaction and restriction fragment length polymorphism analysis. Genotyping assays are performed to determine UGT1A1 promoter genotyping, UGT1A1 coding polymorphisms, TS promoter polymorphisms, and MTHFR polymorphisms.
研究类型
观察性的
注册 (实际的)
308
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
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Quebec
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Montreal、Quebec、加拿大、H2W 1S6
- McGill University
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San Juan、波多黎各、00936-5067
- University of Puerto Rico School of Medicine Medical Sciences Campus
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Alabama
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Anniston、Alabama、美国、36207
- Northeast Alabama Regional Medical Center
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California
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La Jolla、California、美国、92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Los Angeles、California、美国、90048
- Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
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San Diego、California、美国、92161
- Veterans Affairs Medical Center - San Diego
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San Francisco、California、美国、94115
- UCSF Comprehensive Cancer Center
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San Francisco、California、美国、94121
- Veterans Affairs Medical Center - San Francisco
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Delaware
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Newark、Delaware、美国、19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington、District of Columbia、美国、20007
- Lombardi Cancer Center of Georgetown University Medical Center
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Washington、District of Columbia、美国、20307-5000
- Walter Reed Army Medical Center
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Washington、District of Columbia、美国、20422
- Veterans Affairs Medical Center - Washington, DC
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Florida
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Fort Lauderdale、Florida、美国、33316
- Broward General Medical Center
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Hollywood、Florida、美国、33021
- Memorial Regional Hospital Comprehensive Cancer Center
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Miami Beach、Florida、美国、33140
- CCOP - Mount Sinai Medical Center
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Orlando、Florida、美国、32804
- Florida Hospital Cancer Institute
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West Palm Beach、Florida、美国、33401
- Palm Beach Cancer Institute
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Illinois
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Chicago、Illinois、美国、60612-7323
- MBCCOP - University of Illinois at Chicago
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Chicago、Illinois、美国、60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago、Illinois、美国、60637-1470
- University of Chicago Cancer Research Center
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Chicago、Illinois、美国、60640
- Louis A. Weiss Memorial Hospital
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River Forest、Illinois、美国、60305
- West Suburban Center for Cancer Care
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Rockford、Illinois、美国、61108
- Saint Anthony Medical Center
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Indiana
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Fort Wayne、Indiana、美国、46885-5099
- Fort Wayne Medical Oncology and Hematology, Incorporated
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South Bend、Indiana、美国、46601
- CCOP - Northern Indiana CR Consortium
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Iowa
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Iowa City、Iowa、美国、52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
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Kentucky
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Louisville、Kentucky、美国、40207
- Baptist Hospital East - Louisville
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Maryland
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Baltimore、Maryland、美国、21201
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
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Baltimore、Maryland、美国、21201
- Veterans Affairs Medical Center - Baltimore
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Massachusetts
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Boston、Massachusetts、美国、02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Worcester、Massachusetts、美国、01655
- University of Massachusetts Memorial Medical Center - University Campus
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Michigan
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Saint Joseph、Michigan、美国、49085
- Lakeland Medical Center - St. Joseph
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Minnesota
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Minneapolis、Minnesota、美国、55417
- Veterans Affairs Medical Center - Minneapolis
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Minneapolis、Minnesota、美国、55455
- University of Minnesota Cancer Center
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Missouri
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Columbia、Missouri、美国、65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
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Columbia、Missouri、美国、65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Saint Louis、Missouri、美国、63110
- Barnes-Jewish Hospital
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Saint Louis、Missouri、美国、63110
- Siteman Cancer Center
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Saint Louis、Missouri、美国、63131
- Missouri Baptist Cancer Center
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Nebraska
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Omaha、Nebraska、美国、68198-7680
- University of Nebraska Medical Center
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Nevada
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Las Vegas、Nevada、美国、89106
- CCOP - Southern Nevada Cancer Research Foundation
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Las Vegas、Nevada、美国、89106
- Veterans Affairs Medical Center - Las Vegas
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New Hampshire
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Lebanon、New Hampshire、美国、03756-0002
- Norris Cotton Cancer Center at Dartmouth Medical School
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New Jersey
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Camden、New Jersey、美国、08103
- Cooper University Hospital
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New York
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Buffalo、New York、美国、14263-0001
- Roswell Park Cancer Institute
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Buffalo、New York、美国、14215
- Veterans Affairs Medical Center - Buffalo
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Elmhurst、New York、美国、11373
- Elmhurst Hospital Center
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Jamaica、New York、美国、11432
- Queens Cancer Center of Queens Hospital
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Manhasset、New York、美国、11030
- CCOP - North Shore University Hospital
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Manhasset、New York、美国、11030
- North Shore University Hospital
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New York、New York、美国、10021
- Memorial Sloan-Kettering Cancer Center
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New York、New York、美国、10029
- Mount Sinai Medical Center, NY
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New York、New York、美国、10021
- New York Weill Cornell Cancer Center at Cornell University
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Syracuse、New York、美国、13210
- State University of New York - Upstate Medical University
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Syracuse、New York、美国、13210
- Veterans Affairs Medical Center - Syracuse
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Syracuse、New York、美国、13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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North Carolina
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Asheville、North Carolina、美国、28805
- Veterans Affairs Medical Center - Asheville
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Chapel Hill、North Carolina、美国、27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Concord、North Carolina、美国、28025
- NorthEast Oncology Associates
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Durham、North Carolina、美国、27705
- Veterans Affairs Medical Center - Durham
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Durham、North Carolina、美国、27710
- Duke Comprehensive Cancer Center
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Fayetteville、North Carolina、美国、28302-2000
- Cape Fear Valley Health System
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Kinston、North Carolina、美国、28503-1678
- Lenoir Memorial Hospital Cancer Center
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Pinehurst、North Carolina、美国、28374
- Firsthealth Moore Regional Hospital
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Wilmington、North Carolina、美国、28402-9025
- New Hanover Regional Medical Center
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Winston-Salem、North Carolina、美国、27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem、North Carolina、美国、27157-1082
- Comprehensive Cancer Center at Wake Forest University
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North Dakota
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Fargo、North Dakota、美国、58102
- Veterans Affairs Medical Center - Fargo
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Ohio
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Columbus、Ohio、美国、43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Pennsylvania
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Danville、Pennsylvania、美国、17822-2001
- CCOP - Geisinger Clinic and Medical Center
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Pittsburgh、Pennsylvania、美国、15224
- Western Pennsylvania Hospital
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Rhode Island
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Providence、Rhode Island、美国、02906
- Lifespan: The Miriam Hospital
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Texas
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Dallas、Texas、美国、75216
- Veterans Affairs Medical Center - Dallas
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Dallas、Texas、美国、75235-9154
- Simmons Cancer Center at University of Texas Southwestern Medical Center - Dalas
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Vermont
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Bennington、Vermont、美国、05201
- Green Mountain Oncology Group
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Burlington、Vermont、美国、05401-3498
- Vermont Cancer Center at University of Vermont
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White River Junction、Vermont、美国、05009
- Veterans Affairs Medical Center - White River Junction
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Virginia
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Charlottesville、Virginia、美国、22902
- Martha Jefferson Hospital
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Norfolk、Virginia、美国、23502
- Virginia Oncology Associates - Norfolk
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Richmond、Virginia、美国、23298-0037
- MBCCOP - Massey Cancer Center
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Roanoke、Virginia、美国、24014
- Oncology and Hematology Associates of Southwest Virginia, Inc.
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West Virginia
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Huntington、West Virginia、美国、25701
- St. Mary's Medical Center
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Wisconsin
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Green Bay、Wisconsin、美国、54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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Rhinelander、Wisconsin、美国、54501
- Ministry Medical Group - Northern Region
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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 及以上 (成人、年长者)
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 and previously enrolled on CALGB-89803.
描述
DISEASE CHARACTERISTICS:
- Histologically confirmed stage III adenocarcinoma of the colon
Enrolled on CALGB-89803 and must fall into 1 of the following categories:
Received irinotecan, fluorouracil, and leucovorin calcium and experienced at least 1 of the following:
- Grade 3-4 diarrhea
- Grade 4 neutropenia
- Grade 1 or lower diarrhea AND grade 2 or lower neutropenia
Received fluorouracil and leucovorin calcium and experienced at least 1 of the following:
- Grade 3-4 diarrhea
- Grade 1 or lower diarrhea AND grade 2 or lower neutropenia
PATIENT CHARACTERISTICS:
Age
- 18 and over
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
- 观测模型：仅案例
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Group 1
Patients undergo collection of blood specimens for polymerase chain reaction and restriction fragment length polymorphism analysis.
Genotyping assays are performed to determine UGT1A1 promoter genotyping, UGT1A1 coding polymorphisms, TS promoter polymorphisms, and MTHFR polymorphisms.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
response
大体时间：Up to 4 years
|
Up to 4 years
|
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。
调查人员
- 学习椅：Mark J. Ratain, MD、University of Chicago
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4月1日
初级完成 (实际的)
2006年11月1日
研究完成 (实际的)
2006年11月1日
研究注册日期
首次提交
2002年11月12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
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.