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S9719 Gene Damage Following Chemotherapy in Women With Stage II or Stage III Breast Cancer

23. oktober 2015 opdateret af: Southwest Oncology Group

S9719: Clonal Hematopoiesis as a Marker of Genetic Damage Following Adjuvant Chemotherapy for Breast Cancer: Pilot Study to Evaluate Incidence. Ancillary to S9623

RATIONALE: Drugs used in chemotherapy for breast cancer may damage the genes of cells. This may lead to the development of secondary cancers.

PURPOSE: Pilot study to evaluate the degree of gene damage following chemotherapy in women with stage II or stage III breast cancer involving four to nine axillary lymph nodes.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

OBJECTIVES: I. Estimate the incidence of early genetic damage, defined by the presence of clonal hematopoiesis using the human androgen receptor assay (HUMARA), in pretreatment blood and bone marrow, apheresis, and two sequential post-treatment specimens from women with stage II/III breast cancer enrolled in SWOG-S9623. II. Detect genetic damage following dose-intensive adjuvant regimens for breast cancer by screening for the presence of defective DNA mismatch repair mechanisms and loss of heterozygosity using microsatellite instability assays. III. Estimate the incidence of myeloid lymphoid leukemia gene fusion transcripts in cases where either the HUMARA or microsatellite repeat assays are positive for clonal hematopoiesis. IV. Determine the frequency of RAS gene mutations (H-, K-, and N-RAS) following dose-intensive adjuvant regimens for breast cancer.

OUTLINE: Prior to beginning treatment on SWOG-9623, blood samples and bone marrow aspirates (when available) are collected from each patient. Patients randomized to autologous peripheral stem cell transplant have specimens collected again at 3 months (apheresis aliquot and blood). At 3 and 12 months after completing chemotherapy, blood samples are collected from all patients. Samples are collected again from any patient presenting with a second malignancy in the future. DNA is collected from blood or bone marrow samples. Clonality at the HUMARA locus is examined. Microsatellite instability is assessed at multiple chromosomal loci: 7q31, 5q31, 17p12, 8p22, 11q23, and the BAT loci. If the HUMARA or microsatellite repeat assays are positive for clonal hematopoiesis, then specimens are examined for myeloid lymphoid leukemia fusion transcripts commonly reported in acute myeloid leukemia with 11q23 abnormalities. Specimens are also examined for RAS mutations (H-, K-, N-RAS). Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.

PROJECTED ACCRUAL: This study will accrue 100 patients for each arm of SWOG-9623, for a total of 200 patients.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

26

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Mobile, Alabama, Forenede Stater, 36688
        • MBCCOP - University of South Alabama
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006-2726
        • CCOP - Greater Phoenix
      • Phoenix, Arizona, Forenede Stater, 85012
        • Veterans Affairs Medical Center - Phoenix (Hayden)
      • Tucson, Arizona, Forenede Stater, 85724
        • Arizona Cancer Center
      • Tucson, Arizona, Forenede Stater, 85723
        • Veterans Affairs Medical Center - Tucson
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Veterans Affairs Medical Center - Little Rock (McClellan)
    • California
      • Long Beach, California, Forenede Stater, 90822
        • Veterans Affairs Medical Center - Long Beach
      • Los Angeles, California, Forenede Stater, 90033-0800
        • USC/Norris Comprehensive Cancer Center
      • Los Angeles, California, Forenede Stater, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Angeles, California, Forenede Stater, 91010
        • Beckman Research Institute, City of Hope
      • Martinez, California, Forenede Stater, 94553
        • Veterans Affairs Outpatient Clinic - Martinez
      • Oakland, California, Forenede Stater, 94609-3305
        • CCOP - Bay Area Tumor Institute
      • Orange, California, Forenede Stater, 92868
        • Chao Family Comprehensive Cancer Center
      • Sacramento, California, Forenede Stater, 95817
        • University of California Davis Medical Center
      • Santa Rosa, California, Forenede Stater, 95403
        • CCOP - Santa Rosa Memorial Hospital
      • Travis Air Force Base, California, Forenede Stater, 94535
        • David Grant Medical Center
    • Colorado
      • Denver, Colorado, Forenede Stater, 80220
        • Veterans Affairs Medical Center - Denver
      • Denver, Colorado, Forenede Stater, 80262
        • University of Colorado Cancer Center
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342-1701
        • CCOP - Atlanta Regional
      • Fort Gordon, Georgia, Forenede Stater, 30905-5650
        • Dwight David Eisenhower Army Medical Center
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Cancer Research Center of Hawaii
    • Illinois
      • Decatur, Illinois, Forenede Stater, 62526
        • CCOP - Central Illinois
      • Hines, Illinois, Forenede Stater, 60141
        • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
      • Maywood, Illinois, Forenede Stater, 60153
        • Loyola University Medical Center
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160-7357
        • University of Kansas Medical Center
      • Wichita, Kansas, Forenede Stater, 67214-3882
        • CCOP - Wichita
      • Wichita, Kansas, Forenede Stater, 67218
        • Veterans Affairs Medical Center - Wichita
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40511-1093
        • Veterans Affairs Medical Center - Lexington
      • Lexington, Kentucky, Forenede Stater, 40536-0084
        • Albert B. Chandler Medical Center, University of Kentucky
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane University School of Medicine
      • New Orleans, Louisiana, Forenede Stater, 70112
        • MBCCOP - LSU Medical Center
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Veterans Affairs Medical Center - New Orleans
      • Shreveport, Louisiana, Forenede Stater, 71130-3932
        • Louisiana State University Health Sciences Center - Shreveport
      • Shreveport, Louisiana, Forenede Stater, 71130
        • Veterans Affairs Medical Center - Shreveport
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston Medical Center
      • Jamaica Plain, Massachusetts, Forenede Stater, 02130
        • Veterans Affairs Medical Center - Boston (Jamaica Plain)
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109-0752
        • University of Michigan Comprehensive Cancer Center
      • Ann Arbor, Michigan, Forenede Stater, 48105
        • Veterans Affairs Medical Center - Ann Arbor
      • Detroit, Michigan, Forenede Stater, 48201
        • Barbara Ann Karmanos Cancer Institute
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, Forenede Stater, 48201-1932
        • Veterans Affairs Medical Center - Detroit
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • CCOP - Grand Rapids Clinical Oncology Program
      • Southfield, Michigan, Forenede Stater, 48075-9975
        • Providence Hospital - Southfield
    • Mississippi
      • Biloxi, Mississippi, Forenede Stater, 39531-2410
        • Veterans Affairs Medical Center - Biloxi
      • Jackson, Mississippi, Forenede Stater, 39216-4505
        • University of Mississippi Medical Center
      • Jackson, Mississippi, Forenede Stater, 39216
        • Veterans Affairs Medical Center - Jackson
      • Keesler AFB, Mississippi, Forenede Stater, 39534-2576
        • Keesler Medical Center - Keesler AFB
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64128
        • Veterans Affairs Medical Center - Kansas City
      • Kansas City, Missouri, Forenede Stater, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, Forenede Stater, 63110-0250
        • St. Louis University Health Sciences Center
      • Saint Louis, Missouri, Forenede Stater, 63141
        • CCOP - St. Louis-Cape Girardeau
      • Springfield, Missouri, Forenede Stater, 65807
        • CCOP - Cancer Research for the Ozarks
    • Montana
      • Billings, Montana, Forenede Stater, 59101
        • CCOP - Montana Cancer Consortium
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87108-5138
        • Veterans Affairs Medical Center - Albuquerque
      • Albuquerque, New Mexico, Forenede Stater, 87131
        • MBCCOP - University of New Mexico HSC
    • New York
      • New York, New York, Forenede Stater, 10032
        • Herbert Irving Comprehensive Cancer Center
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Barrett Cancer Center, The University Hospital
      • Cincinnati, Ohio, Forenede Stater, 45220-2288
        • Veterans Affairs Medical Center - Cincinnati
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Columbus, Ohio, Forenede Stater, 43206
        • CCOP - Columbus
      • Dayton, Ohio, Forenede Stater, 45428
        • Veterans Affairs Medical Center - Dayton
      • Kettering, Ohio, Forenede Stater, 45429
        • CCOP - Dayton
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Oklahoma Medical Research Foundation
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Veterans Affairs Medical Center - Oklahoma City
    • Oregon
      • Portland, Oregon, Forenede Stater, 97201-3098
        • Oregon Cancer Center at Oregon Health Sciences University
      • Portland, Oregon, Forenede Stater, 97207
        • Veterans Affairs Medical Center - Portland
      • Portland, Oregon, Forenede Stater, 97213
        • CCOP - Columbia River Program
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29615
        • CCOP - Greenville
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • CCOP - Upstate Carolina
    • Texas
      • Fort Sam Houston, Texas, Forenede Stater, 78234
        • Brooke Army Medical Center
      • Galveston, Texas, Forenede Stater, 77555-1329
        • University of Texas Medical Branch
      • Lubbock, Texas, Forenede Stater, 79423
        • Texas Tech University Health Science Center
      • San Antonio, Texas, Forenede Stater, 78284-7811
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, Forenede Stater, 78284
        • Veterans Affairs Medical Center - San Antonio (Murphy)
      • Temple, Texas, Forenede Stater, 76504
        • Veterans Affairs Medical Center - Temple
      • Temple, Texas, Forenede Stater, 76508
        • CCOP - Scott and White Hospital
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84132
        • Huntsman Cancer Institute
      • Salt Lake City, Utah, Forenede Stater, 84148
        • Veterans Affairs Medical Center - Salt Lake City
    • Washington
      • Seattle, Washington, Forenede Stater, 98101
        • CCOP - Virginia Mason Research Center
      • Seattle, Washington, Forenede Stater, 98104
        • Swedish Cancer Institute
      • Seattle, Washington, Forenede Stater, 98108
        • Veterans Affairs Medical Center - Seattle
      • Tacoma, Washington, Forenede Stater, 98405-0986
        • CCOP - Northwest

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 120 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Must be enrolled in SWOG-9623 at time of registration to this study, but must not have started treatment Hormone receptor status: Not specified

Beskrivelse

DISEASE CHARACTERISTICS: Must be enrolled in SWOG-9623 at time of registration to this study, but must not have started treatment Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Adult Sex: Female Menopausal status: Not specified Performance status: See Disease Characteristics Life expectancy: SWOG 0 or 1 Hematopoietic: See Disease Characteristics Hepatic: See Disease Characteristics Renal: See Disease Characteristics

PRIOR CONCURRENT THERAPY: 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
bone marrow transplant
standard chemotherapy

Samarbejdspartnere og efterforskere

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

Sponsor

Southwest Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Studiestol: Marilyn L. Slovak, PhD, City of Hope Comprehensive 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. november 1997

Primær færdiggørelse (Faktiske)

1. februar 2001

Studieafslutning (Faktiske)

1. februar 2001

Datoer for studieregistrering

Først indsendt

1. november 1999

Først indsendt, der opfyldte QC-kriterier

18. maj 2004

Først opslået (Skøn)

19. maj 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. oktober 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. oktober 2015

Sidst verificeret

1. oktober 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000065813
  • U10CA032102 (U.S. NIH-bevilling/kontrakt)
  • S9719 (Anden identifikator: SWOG)

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 .

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Betingelser

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