Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

23. oktober 2015 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Brystkreft

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

Kontakter og plasseringer

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

Studiesteder

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

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 120 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

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

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
bone marrow transplant
standard chemotherapy

Samarbeidspartnere og etterforskere

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

Sponsor

Southwest Oncology Group

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

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

Primær fullføring (Faktiske)

1. februar 2001

Studiet fullført (Faktiske)

1. februar 2001

Datoer for studieregistrering

Først innsendt

1. november 1999

Først innsendt som oppfylte QC-kriteriene

18. mai 2004

Først lagt ut (Anslag)

19. mai 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

26. oktober 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. oktober 2015

Sist bekreftet

1. oktober 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

CDR0000065813
U10CA032102 (U.S. NIH-stipend/kontrakt)
S9719 (Annen identifikator: SWOG)

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. .