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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

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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 CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Abington Memorial HospitalAbington, Pennsylvania  19001
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Northwest Community HospitalArlington Heights, Illinois  60005
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Deaconess Medical CenterSpokane, Washington  99210-0248
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
UPMC Cancer Center at Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
City of Hope Comprehensive Cancer CenterDuarte, California  91010
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Natalie Warren Bryant Cancer CenterTulsa, Oklahoma  74136
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Central Baptist HospitalLexington, Kentucky  40503
Massey Cancer Center at Virginia Commonwealth UniversityRichmond, Virginia  23298-0037
Lahey Clinic Medical Center - BurlingtonBurlington, Massachusetts  01805
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - OmahaOmaha, Nebraska  68114-4199
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
St. Agnes Cancer CenterBaltimore, Maryland  21229
Fletcher Allen Health Care - Medical Center CampusBurlington, Vermont  05401
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Shands Cancer Center at the University of Florida Health Science CenterGainesville, Florida  32610-0296
Brigham and Women's HospitalBoston, Massachusetts  02115
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Baylor University Medical CenterDallas, Texas  75246
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
Providence Cancer Center at Holy Family HospitalSpokane, Washington  99207
Cancer Center at Creighton University Medical CenterOmaha, Nebraska  68131
Morton Plant HospitalClearwater, Florida  33756
Baptist HospitalNashville, Tennessee  37236
Methodist HospitalHouston, Texas  77030
Froedtert Memorial Lutheran HospitalMilwaukee, Wisconsin  53226
Providence Cancer CenterMobile, Alabama  36608
Arrowhead Regional Medical CenterColton, California  92324-1819
Surgical Oncology of Northeast GeorgiaGainesville, Georgia  30501
Great Lakes Cancer Institute - McLarenFlint, Michigan  48532
Baptist Cancer Institute at Baptist Memorial Hospital - MemphisMemphis, Tennessee  38120
INOVA Fair Oaks HospitalFairfax, Virginia  22033
Presbyterian HospitalCharlotte, North Carolina  28233-3549
Rush Copley Medical CenterAurora, Illinois  60504-4206
Presbyterian Hospital of DallasDallas, Texas  75231
Akron General's McDowell Cancer CenterAkron, Ohio  44302
Digestive Health Specialists, P.A.Tupelo, Mississippi  38801
Integris Oncology ServicesOklahoma City, Oklahoma  73112
Sarah Cannon Cancer Center at Parkridge Medical CenterChattanooga, Tennessee  37404-3285
Associated Surgeons P.S.Spokane, Washington  99204
Sacred Heart Medical CenterSpokane, Washington  99204
Appleton Medical CenterAppleton, Wisconsin  54911
Fox Valley Surgical Associates at Appleton Medical CenterAppleton, Wisconsin  54911-3454