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Genetic Study of Young Patients With Colorectal Cancer

1. juli 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

651

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 49 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / 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: mikrosatellit-ustabilitetsanalyse

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
samlet overlevelse
Tidsramme: Op til 2 år
Op til 2 år

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2002

Primær færdiggørelse (Faktiske)

1. december 2004

Studieafslutning (Faktiske)

1. december 2004

Datoer for studieregistrering

Først indsendt

6. september 2002

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. juli 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juli 2016

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kolorektal cancer

Kliniske forsøg med mikrosatellit-ustabilitetsanalyse

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Bahamas

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner