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Genetic Study of Young Patients With Colorectal Cancer

1 luglio 2016 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

651

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 49 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Patients diagnosed with adenocarcinoma of the colon or rectum.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Genetico: analisi dell'instabilità dei microsatelliti

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
sopravvivenza globale
Lasso di tempo: Fino a 2 anni
Fino a 2 anni

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Alliance for Clinical Trials in Oncology

Collaboratori

National Cancer Institute (NCI)

Investigatori

  • Cattedra di studio: Jose G. Guillem, MD, Memorial Sloan Kettering Cancer Center

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2002

Completamento primario (Effettivo)

1 dicembre 2004

Completamento dello studio (Effettivo)

1 dicembre 2004

Date di iscrizione allo studio

Primo inviato

6 settembre 2002

Primo inviato che soddisfa i criteri di controllo qualità

26 gennaio 2003

Primo Inserito (Stima)

27 gennaio 2003

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

6 luglio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 luglio 2016

Ultimo verificato

1 luglio 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ACOSOG-Z0190
  • CDR0000069465 (Identificatore di registro: NCI Physician Data Query)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

Malattie rare

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