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Genetic Study of Young Patients With Colorectal Cancer

1. juli 2016 oppdatert av: Alliance for Clinical Trials in Oncology

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

651

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • Ontario
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto Sunnybrook Regional Cancer Centre
  • Forente stater
    • Alabama
      • Mobile, Alabama, Forente stater, 36640-0460
        • Mobile Infirmary Medical Center
      • Mobile, Alabama, Forente stater, 36608
        • Providence Cancer Center
    • California
      • Colton, California, Forente stater, 92324-1819
        • Arrowhead Regional Medical Center
      • Duarte, California, Forente stater, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • San Francisco, California, Forente stater, 94115
        • UCSF Comprehensive Cancer Center
    • Florida
      • Clearwater, Florida, Forente stater, 33756
        • Morton Plant Hospital
      • Fort Lauderdale, Florida, Forente stater, 33308
        • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
      • Gainesville, Florida, Forente stater, 32610-100277
        • Shands Cancer Center at the University of Florida Health Science Center
      • Tampa, Florida, Forente stater, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Gainesville, Georgia, Forente stater, 30501
        • Surgical Oncology of Northeast Georgia
    • Illinois
      • Arlington Heights, Illinois, Forente stater, 60005
        • Northwest Community Hospital
      • Aurora, Illinois, Forente stater, 60504-4206
        • Rush Copley Medical Center
      • Chicago, Illinois, Forente stater, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, Forente stater, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
      • Maywood, Illinois, Forente stater, 60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202
        • Indiana University Cancer Center
    • Iowa
      • Des Moines, Iowa, Forente stater, 50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Iowa City, Iowa, Forente stater, 52242-1009
        • Holden Comprehensive Cancer Center at University of Iowa
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40503-9985
        • Central Baptist Hospital
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70121
        • Ochsner Clinic Foundation
      • Shreveport, Louisiana, Forente stater, 71130-3932
        • Louisiana State University Health Sciences Center - Shreveport
    • Maryland
      • Baltimore, Maryland, Forente stater, 21201
        • Greenebaum Cancer Center at University of Maryland Medical Center
      • Baltimore, Maryland, Forente stater, 21229
        • St. Agnes Cancer Center
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Brigham and Women's Hospital
      • Burlington, Massachusetts, Forente stater, 01805
        • Lahey Clinic Medical Center - Burlington
      • Worcester, Massachusetts, Forente stater, 01655
        • UMASS Memorial Cancer Center - University Campus
    • Michigan
      • Flint, Michigan, Forente stater, 48532
        • Great Lakes Cancer Institute - McLaren
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55455
        • University of Minnesota Cancer Center
    • Mississippi
      • Tupelo, Mississippi, Forente stater, 38801
        • Digestive Health Specialists, P.A.
    • Missouri
      • Columbia, Missouri, Forente stater, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Saint Louis, Missouri, Forente stater, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68114-4199
        • Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
      • Omaha, Nebraska, Forente stater, 68131-2197
        • Cancer Center at Creighton University Medical Center
    • New York
      • New York, New York, Forente stater, 10021
        • Memorial Sloan-Kettering Cancer Center
      • Rochester, New York, Forente stater, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Charlotte, North Carolina, Forente stater, 28204
        • Presbyterian Hospital
      • Durham, North Carolina, Forente stater, 27710
        • Duke Comprehensive Cancer Center
      • Winston-Salem, North Carolina, Forente stater, 27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • Ohio
      • Akron, Ohio, Forente stater, 44302
        • Akron General's McDowell Cancer Center
      • Cleveland, Ohio, Forente stater, 44195
        • Cleveland Clinic Taussig Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73112
        • Integris Oncology Services
      • Tulsa, Oklahoma, Forente stater, 74136
        • Natalie Warren Bryant Cancer Center
    • Pennsylvania
      • Abington, Pennsylvania, Forente stater, 19001
        • Abington Memorial Hospital
      • Philadelphia, Pennsylvania, Forente stater, 19104-4283
        • Abramson Cancer Center of the University of Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19107-5541
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Pittsburgh, Pennsylvania, Forente stater, 15224
        • Western Pennsylvania Hospital
      • Pittsburgh, Pennsylvania, Forente stater, 15212-4772
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • UPMC Cancer Center at Magee-Womens Hospital
    • Tennessee
      • Chattanooga, Tennessee, Forente stater, 37404-3285
        • Sarah Cannon Cancer Center at Parkridge Medical Center
      • Memphis, Tennessee, Forente stater, 38120
        • Baptist Cancer Institute at Baptist Memorial Hospital - Memphis
      • Nashville, Tennessee, Forente stater, 37236
        • Baptist Hospital
      • Nashville, Tennessee, Forente stater, 37232-6860
        • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
    • Texas
      • Dallas, Texas, Forente stater, 75246
        • Baylor University Medical Center
      • Dallas, Texas, Forente stater, 75231
        • Presbyterian Hospital of Dallas
      • Houston, Texas, Forente stater, 77030-4009
        • University of Texas - MD Anderson Cancer Center
      • Houston, Texas, Forente stater, 77030
        • Methodist Hospital
    • Utah
      • Salt Lake City, Utah, Forente stater, 84132
        • Huntsman Cancer Institute
    • Vermont
      • Burlington, Vermont, Forente stater, 05401
        • Fletcher Allen Health Care - Medical Center Campus
    • Virginia
      • Fairfax, Virginia, Forente stater, 22033
        • Inova Fair Oaks Hospital
      • Falls Church, Virginia, Forente stater, 22042-3300
        • Inova Fairfax Hospital
      • Richmond, Virginia, Forente stater, 23298-0037
        • Massey Cancer Center at Virginia Commonwealth University
    • Washington
      • Spokane, Washington, Forente stater, 99210-0248
        • Deaconess Medical Center
      • Spokane, Washington, Forente stater, 99204
        • Sacred Heart Medical Center
      • Spokane, Washington, Forente stater, 99204
        • Associated Surgeons P.S.
      • Spokane, Washington, Forente stater, 99208
        • Providence Cancer Center at Holy Family Hospital
    • Wisconsin
      • Appleton, Wisconsin, Forente stater, 54911
        • Appleton Medical Center
      • Appleton, Wisconsin, Forente stater, 54911-3454
        • Fox Valley Surgical Associates at Appleton Medical Center
      • Madison, Wisconsin, Forente stater, 53792-7375
        • University of Wisconsin Comprehensive Cancer Center
      • Milwaukee, Wisconsin, Forente stater, 53226
        • Medical College of Wisconsin Cancer Center
      • Milwaukee, Wisconsin, Forente stater, 53226
        • Froedtert Memorial Lutheran Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 49 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients diagnosed with adenocarcinoma of the colon or rectum.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Genetisk: mikrosatellitt ustabilitetsanalyse

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
total overlevelse
Tidsramme: Inntil 2 år
Inntil 2 år

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Studiestol: Jose G. Guillem, MD, Memorial Sloan Kettering Cancer Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2002

Primær fullføring (Faktiske)

1. desember 2004

Studiet fullført (Faktiske)

1. desember 2004

Datoer for studieregistrering

Først innsendt

6. september 2002

Først innsendt som oppfylte QC-kriteriene

26. januar 2003

Først lagt ut (Anslag)

27. januar 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

6. juli 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juli 2016

Sist bekreftet

1. juli 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ACOSOG-Z0190
  • CDR0000069465 (Registeridentifikator: NCI Physician Data Query)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Tykktarmskreft

Kliniske studier på mikrosatellitt ustabilitetsanalyse

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Brazil

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

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