Genetic Study of Young Patients With Colorectal Cancer

NCT00044967 | Completed

• 2 other identifiers: ACOSOG-Z0190CDR0000069465
• Study Type: observational
• Target: 651
• Locations: 2 countries
• Sites: 73

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

stage I colon cancer; stage II colon cancer; stage III colon cancer; stage I rectal cancer; stage II rectal cancer; stage III rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum

Outcome Measures

Primary Outcomes (1)

• overall survival

  Up to 2 years

Study Arms (1)

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.

Genetic: microsatellite instability analysis

Interventions

microsatellite instability analysis GENETIC

Group 1

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with adenocarcinoma of the colon or rectum.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (73)

Providence Cancer Center

Mobile, Alabama, 36608, United States

Location

Mobile Infirmary Medical Center

Mobile, Alabama, 36640-0460, United States

Location

Arrowhead Regional Medical Center

Colton, California, 92324-1819, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Shands Cancer Center at the University of Florida Health Science Center

Gainesville, Florida, 32610-100277, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Surgical Oncology of Northeast Georgia

Gainesville, Georgia, 30501, United States

Location

Northwest Community Hospital

Arlington Heights, Illinois, 60005, United States

Location

Rush Copley Medical Center

Aurora, Illinois, 60504-4206, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1009, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503-9985, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, 71130-3932, United States

Location

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

St. Agnes Cancer Center

Baltimore, Maryland, 21229, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Lahey Clinic Medical Center - Burlington

Burlington, Massachusetts, 01805, United States

Location

UMASS Memorial Cancer Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

Great Lakes Cancer Institute - McLaren

Flint, Michigan, 48532, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Digestive Health Specialists, P.A.

Tupelo, Mississippi, 38801, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha

Omaha, Nebraska, 68114-4199, United States

Location

Cancer Center at Creighton University Medical Center

Omaha, Nebraska, 68131-2197, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Presbyterian Hospital

Charlotte, North Carolina, 28204, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Akron General's McDowell Cancer Center

Akron, Ohio, 44302, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Integris Oncology Services

Oklahoma City, Oklahoma, 73112, United States

Location

Natalie Warren Bryant Cancer Center

Tulsa, Oklahoma, 74136, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212-4772, United States

Location

UPMC Cancer Center at Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Sarah Cannon Cancer Center at Parkridge Medical Center

Chattanooga, Tennessee, 37404-3285, United States

Location

Baptist Cancer Institute at Baptist Memorial Hospital - Memphis

Memphis, Tennessee, 38120, United States

Location

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

Nashville, Tennessee, 37232-6860, United States

Location

Baptist Hospital

Nashville, Tennessee, 37236, United States

Location

Presbyterian Hospital of Dallas

Dallas, Texas, 75231, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Methodist Hospital

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84132, United States

Location

Fletcher Allen Health Care - Medical Center Campus

Burlington, Vermont, 05401, United States

Location

INOVA Fair Oaks Hospital

Fairfax, Virginia, 22033, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042-3300, United States

Location

Massey Cancer Center at Virginia Commonwealth University

Richmond, Virginia, 23298-0037, United States

Location

Associated Surgeons P.S.

Spokane, Washington, 99204, United States

Location

Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

Providence Cancer Center at Holy Family Hospital

Spokane, Washington, 99208, United States

Location

Deaconess Medical Center

Spokane, Washington, 99210-0248, United States

Location

Fox Valley Surgical Associates at Appleton Medical Center

Appleton, Wisconsin, 54911-3454, United States

Location

Appleton Medical Center

Appleton, Wisconsin, 54911, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-7375, United States

Location

Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Regional Cancer Care at Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jose G. Guillem, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2002
• First Posted: January 27, 2003
• Study Start: May 1, 2002
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: July 6, 2016

Record last verified: 2016-07

Locations

US (71); CA (2)