Know Cancer

forgot password

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

18 Years
49 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

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


- 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

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.

PROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study within 6 years.

Inclusion Criteria


- 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

- 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



- 18 to 49 at first diagnosis

Performance status

- Not specified

Life expectancy

- Not specified


- Not specified


- Not specified


- Not specified


- 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


Biologic therapy

- Not specified


- Not specified

Endocrine therapy

- Not specified


- No prior pelvic radiotherapy for rectal cancer

- No concurrent preoperative pelvic radiotherapy for rectal cancer


- See Disease Characteristics

Type of Study:


Study Design:


Principal Investigator

Jose G. Guillem, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 2002

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • 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
  • Colorectal Neoplasms
  • Microsatellite Instability



Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Abington Memorial Hospital Abington, Pennsylvania  19001
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Huntsman Cancer Institute Salt Lake City, Utah  84112
Northwest Community Hospital Arlington Heights, Illinois  60005
Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224
Deaconess Medical Center Spokane, Washington  99210-0248
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University Campus Worcester, Massachusetts  01605-2982
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish Hospital Saint Louis, Missouri  63110
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
UPMC Cancer Center at Magee-Womens Hospital Pittsburgh, Pennsylvania  15213-3180
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center Nashville, Tennessee  37232-2516
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Louisiana State University Health Sciences Center - Shreveport Shreveport, Louisiana  71130-3932
Allegheny General Hospital Pittsburgh, Pennsylvania  15212-4772
Ochsner Clinic Foundation New Orleans, Louisiana  70121
Inova Fairfax Hospital Falls Church, Virginia  22042-3300
City of Hope Comprehensive Cancer Center Duarte, California  91010
UCSF Comprehensive Cancer Center San Francisco, California  94115
Mobile Infirmary Medical Center Mobile, Alabama  36640-0460
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
Natalie Warren Bryant Cancer Center Tulsa, Oklahoma  74136
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
Central Baptist Hospital Lexington, Kentucky  40503
Massey Cancer Center at Virginia Commonwealth University Richmond, Virginia  23298-0037
Lahey Clinic Medical Center - Burlington Burlington, Massachusetts  01805
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha Omaha, Nebraska  68114-4199
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
St. Agnes Cancer Center Baltimore, Maryland  21229
Fletcher Allen Health Care - Medical Center Campus Burlington, Vermont  05401
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201
Shands Cancer Center at the University of Florida Health Science Center Gainesville, Florida  32610-0296
Brigham and Women's Hospital Boston, Massachusetts  02115
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Baylor University Medical Center Dallas, Texas  75246
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Fort Lauderdale, Florida  33308
Providence Cancer Center at Holy Family Hospital Spokane, Washington  99207
Cancer Center at Creighton University Medical Center Omaha, Nebraska  68131
Morton Plant Hospital Clearwater, Florida  33756
Baptist Hospital Nashville, Tennessee  37236
Methodist Hospital Houston, Texas  77030
Froedtert Memorial Lutheran Hospital Milwaukee, Wisconsin  53226
Providence Cancer Center Mobile, Alabama  36608
Arrowhead Regional Medical Center Colton, California  92324-1819
Surgical Oncology of Northeast Georgia Gainesville, Georgia  30501
Great Lakes Cancer Institute - McLaren Flint, Michigan  48532
Baptist Cancer Institute at Baptist Memorial Hospital - Memphis Memphis, Tennessee  38120
INOVA Fair Oaks Hospital Fairfax, Virginia  22033
Presbyterian Hospital Charlotte, North Carolina  28233-3549
Rush Copley Medical Center Aurora, Illinois  60504-4206
Presbyterian Hospital of Dallas Dallas, Texas  75231
Akron General's McDowell Cancer Center Akron, Ohio  44302
Digestive Health Specialists, P.A. Tupelo, Mississippi  38801
Integris Oncology Services Oklahoma City, Oklahoma  73112
Sarah Cannon Cancer Center at Parkridge Medical Center Chattanooga, Tennessee  37404-3285
Associated Surgeons P.S. Spokane, Washington  99204
Sacred Heart Medical Center Spokane, Washington  99204
Appleton Medical Center Appleton, Wisconsin  54911
Fox Valley Surgical Associates at Appleton Medical Center Appleton, Wisconsin  54911-3454