Genetic Study of Young Patients With Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00044967
• Other study ID #: ACOSOG-Z0190
• Secondary ID: ACOSOG-Z0190CDR0
• Status: Completed
• Phase: N/A
• First received: September 6, 2002
• Last updated: July 1, 2016
• Start date: May 2002
• Est. completion date: December 2004

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 651
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Microsatellite Instability

Intervention

Genetic:
• microsatellite instability analysis

Locations

Country	Name	City	State
Canada	Regional Cancer Care at Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario
Canada	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Akron General's McDowell Cancer Center	Akron	Ohio
United States	Appleton Medical Center	Appleton	Wisconsin
United States	Fox Valley Surgical Associates at Appleton Medical Center	Appleton	Wisconsin
United States	Northwest Community Hospital	Arlington Heights	Illinois
United States	Rush Copley Medical Center	Aurora	Illinois
United States	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland
United States	St. Agnes Cancer Center	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Fletcher Allen Health Care - Medical Center Campus	Burlington	Vermont
United States	Lahey Clinic Medical Center - Burlington	Burlington	Massachusetts
United States	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina
United States	Presbyterian Hospital	Charlotte	North Carolina
United States	Sarah Cannon Cancer Center at Parkridge Medical Center	Chattanooga	Tennessee
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Morton Plant Hospital	Clearwater	Florida
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Arrowhead Regional Medical Center	Colton	California
United States	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri
United States	Baylor University Medical Center	Dallas	Texas
United States	Presbyterian Hospital of Dallas	Dallas	Texas
United States	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	INOVA Fair Oaks Hospital	Fairfax	Virginia
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Great Lakes Cancer Institute - McLaren	Flint	Michigan
United States	Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital	Fort Lauderdale	Florida
United States	Shands Cancer Center at the University of Florida Health Science Center	Gainesville	Florida
United States	Surgical Oncology of Northeast Georgia	Gainesville	Georgia
United States	Methodist Hospital	Houston	Texas
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	Central Baptist Hospital	Lexington	Kentucky
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois
United States	Baptist Cancer Institute at Baptist Memorial Hospital - Memphis	Memphis	Tennessee
United States	Froedtert Memorial Lutheran Hospital	Milwaukee	Wisconsin
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	Providence Cancer Center	Mobile	Alabama
United States	Baptist Hospital	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center	Nashville	Tennessee
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Integris Oncology Services	Oklahoma City	Oklahoma
United States	Cancer Center at Creighton University Medical Center	Omaha	Nebraska
United States	Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha	Omaha	Nebraska
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	UPMC Cancer Center at Magee-Womens Hospital	Pittsburgh	Pennsylvania
United States	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Massey Cancer Center at Virginia Commonwealth University	Richmond	Virginia
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	Siteman Cancer Center at Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	UCSF Comprehensive Cancer Center	San Francisco	California
United States	Louisiana State University Health Sciences Center - Shreveport	Shreveport	Louisiana
United States	Associated Surgeons P.S.	Spokane	Washington
United States	Deaconess Medical Center	Spokane	Washington
United States	Providence Cancer Center at Holy Family Hospital	Spokane	Washington
United States	Sacred Heart Medical Center	Spokane	Washington
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Natalie Warren Bryant Cancer Center	Tulsa	Oklahoma
United States	Digestive Health Specialists, P.A.	Tupelo	Mississippi
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina
United States	UMASS Memorial Cancer Center - University Campus	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		Up to 2 years	No