Genetic Study of Young Patients With Colorectal Cancer
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
Ontario
-
Thunder Bay, Ontario, Canadá, P7B 6V4
- Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
-
Toronto, Ontario, Canadá, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
-
-
-
-
Alabama
-
Mobile, Alabama, Estados Unidos, 36640-0460
- Mobile Infirmary Medical Center
-
Mobile, Alabama, Estados Unidos, 36608
- Providence Cancer Center
-
-
California
-
Colton, California, Estados Unidos, 92324-1819
- Arrowhead Regional Medical Center
-
Duarte, California, Estados Unidos, 91010-3000
- City of Hope Comprehensive Cancer Center
-
San Francisco, California, Estados Unidos, 94115
- UCSF Comprehensive Cancer Center
-
-
Florida
-
Clearwater, Florida, Estados Unidos, 33756
- Morton Plant Hospital
-
Fort Lauderdale, Florida, Estados Unidos, 33308
- Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
-
Gainesville, Florida, Estados Unidos, 32610-100277
- Shands Cancer Center at the University of Florida Health Science Center
-
Tampa, Florida, Estados Unidos, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Georgia
-
Gainesville, Georgia, Estados Unidos, 30501
- Surgical Oncology of Northeast Georgia
-
-
Illinois
-
Arlington Heights, Illinois, Estados Unidos, 60005
- Northwest Community Hospital
-
Aurora, Illinois, Estados Unidos, 60504-4206
- Rush Copley Medical Center
-
Chicago, Illinois, Estados Unidos, 60637-1470
- University of Chicago Cancer Research Center
-
Chicago, Illinois, Estados Unidos, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
-
Maywood, Illinois, Estados Unidos, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
-
-
Indiana
-
Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University Cancer Center
-
-
Iowa
-
Des Moines, Iowa, Estados Unidos, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
-
Iowa City, Iowa, Estados Unidos, 52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
-
-
Kentucky
-
Lexington, Kentucky, Estados Unidos, 40503-9985
- Central Baptist Hospital
-
-
Louisiana
-
New Orleans, Louisiana, Estados Unidos, 70121
- Ochsner Clinic Foundation
-
Shreveport, Louisiana, Estados Unidos, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21201
- Greenebaum Cancer Center at University of Maryland Medical Center
-
Baltimore, Maryland, Estados Unidos, 21229
- St. Agnes Cancer Center
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02115
- Brigham and Women's Hospital
-
Burlington, Massachusetts, Estados Unidos, 01805
- Lahey Clinic Medical Center - Burlington
-
Worcester, Massachusetts, Estados Unidos, 01655
- UMASS Memorial Cancer Center - University Campus
-
-
Michigan
-
Flint, Michigan, Estados Unidos, 48532
- Great Lakes Cancer Institute - McLaren
-
-
Minnesota
-
Minneapolis, Minnesota, Estados Unidos, 55455
- University of Minnesota Cancer Center
-
-
Mississippi
-
Tupelo, Mississippi, Estados Unidos, 38801
- Digestive Health Specialists, P.A.
-
-
Missouri
-
Columbia, Missouri, Estados Unidos, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
-
Saint Louis, Missouri, Estados Unidos, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
-
-
Nebraska
-
Omaha, Nebraska, Estados Unidos, 68114-4199
- Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
-
Omaha, Nebraska, Estados Unidos, 68131-2197
- Cancer Center at Creighton University Medical Center
-
-
New York
-
New York, New York, Estados Unidos, 10021
- Memorial Sloan-Kettering Cancer Center
-
Rochester, New York, Estados Unidos, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
-
-
North Carolina
-
Charlotte, North Carolina, Estados Unidos, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
-
Charlotte, North Carolina, Estados Unidos, 28204
- Presbyterian Hospital
-
Durham, North Carolina, Estados Unidos, 27710
- Duke Comprehensive Cancer Center
-
Winston-Salem, North Carolina, Estados Unidos, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
-
-
Ohio
-
Akron, Ohio, Estados Unidos, 44302
- Akron General's McDowell Cancer Center
-
Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Taussig Cancer Center
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Estados Unidos, 73112
- Integris Oncology Services
-
Tulsa, Oklahoma, Estados Unidos, 74136
- Natalie Warren Bryant Cancer Center
-
-
Pennsylvania
-
Abington, Pennsylvania, Estados Unidos, 19001
- Abington Memorial Hospital
-
Philadelphia, Pennsylvania, Estados Unidos, 19104-4283
- Abramson Cancer Center of the University of Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19107-5541
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
-
Pittsburgh, Pennsylvania, Estados Unidos, 15224
- Western Pennsylvania Hospital
-
Pittsburgh, Pennsylvania, Estados Unidos, 15212-4772
- Allegheny General Hospital
-
Pittsburgh, Pennsylvania, Estados Unidos, 15213
- UPMC Cancer Center at Magee-Womens Hospital
-
-
Tennessee
-
Chattanooga, Tennessee, Estados Unidos, 37404-3285
- Sarah Cannon Cancer Center at Parkridge Medical Center
-
Memphis, Tennessee, Estados Unidos, 38120
- Baptist Cancer Institute at Baptist Memorial Hospital - Memphis
-
Nashville, Tennessee, Estados Unidos, 37236
- Baptist Hospital
-
Nashville, Tennessee, Estados Unidos, 37232-6860
- Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
-
-
Texas
-
Dallas, Texas, Estados Unidos, 75246
- Baylor University Medical Center
-
Dallas, Texas, Estados Unidos, 75231
- Presbyterian Hospital of Dallas
-
Houston, Texas, Estados Unidos, 77030-4009
- University of Texas - MD Anderson Cancer Center
-
Houston, Texas, Estados Unidos, 77030
- Methodist Hospital
-
-
Utah
-
Salt Lake City, Utah, Estados Unidos, 84132
- Huntsman Cancer Institute
-
-
Vermont
-
Burlington, Vermont, Estados Unidos, 05401
- Fletcher Allen Health Care - Medical Center Campus
-
-
Virginia
-
Fairfax, Virginia, Estados Unidos, 22033
- Inova Fair Oaks Hospital
-
Falls Church, Virginia, Estados Unidos, 22042-3300
- INOVA Fairfax Hospital
-
Richmond, Virginia, Estados Unidos, 23298-0037
- Massey Cancer Center at Virginia Commonwealth University
-
-
Washington
-
Spokane, Washington, Estados Unidos, 99210-0248
- Deaconess Medical Center
-
Spokane, Washington, Estados Unidos, 99204
- Sacred Heart Medical Center
-
Spokane, Washington, Estados Unidos, 99204
- Associated Surgeons P.S.
-
Spokane, Washington, Estados Unidos, 99208
- Providence Cancer Center at Holy Family Hospital
-
-
Wisconsin
-
Appleton, Wisconsin, Estados Unidos, 54911
- Appleton Medical Center
-
Appleton, Wisconsin, Estados Unidos, 54911-3454
- Fox Valley Surgical Associates at Appleton Medical Center
-
Madison, Wisconsin, Estados Unidos, 53792-7375
- University of Wisconsin Comprehensive Cancer Center
-
Milwaukee, Wisconsin, Estados Unidos, 53226
- Medical College of Wisconsin Cancer Center
-
Milwaukee, Wisconsin, Estados Unidos, 53226
- Froedtert Memorial Lutheran Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
sobrevida global
Prazo: Até 2 anos
|
Até 2 anos
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Jose G. Guillem, MD, Memorial Sloan Kettering Cancer Center
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ACOSOG-Z0190
- CDR0000069465 (Identificador de registro: NCI Physician Data Query)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .