- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00003095
S9719 Gene Damage Following Chemotherapy in Women With Stage II or Stage III Breast Cancer
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Alabama
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Mobile, Alabama, Stati Uniti, 36688
- MBCCOP - University of South Alabama
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Arizona
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Phoenix, Arizona, Stati Uniti, 85006-2726
- CCOP - Greater Phoenix
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Phoenix, Arizona, Stati Uniti, 85012
- Veterans Affairs Medical Center - Phoenix (Hayden)
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Tucson, Arizona, Stati Uniti, 85724
- Arizona Cancer Center
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Tucson, Arizona, Stati Uniti, 85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, Stati Uniti, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, Stati Uniti, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Long Beach, California, Stati Uniti, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, Stati Uniti, 90033-0800
- USC/Norris Comprehensive Cancer Center
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Los Angeles, California, Stati Uniti, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Stati Uniti, 91010
- Beckman Research Institute, City of Hope
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Martinez, California, Stati Uniti, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland, California, Stati Uniti, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, Stati Uniti, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, Stati Uniti, 95817
- University of California Davis Medical Center
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Santa Rosa, California, Stati Uniti, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, Stati Uniti, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, Stati Uniti, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, Stati Uniti, 80262
- University of Colorado Cancer Center
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Georgia
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Atlanta, Georgia, Stati Uniti, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, Stati Uniti, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, Stati Uniti, 96813
- Cancer Research Center of Hawaii
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Illinois
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Decatur, Illinois, Stati Uniti, 62526
- CCOP - Central Illinois
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Hines, Illinois, Stati Uniti, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, Stati Uniti, 60153
- Loyola University Medical Center
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Kansas
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Kansas City, Kansas, Stati Uniti, 66160-7357
- University of Kansas Medical Center
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Wichita, Kansas, Stati Uniti, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, Stati Uniti, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40511-1093
- Veterans Affairs Medical Center - Lexington
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Lexington, Kentucky, Stati Uniti, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Louisiana
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New Orleans, Louisiana, Stati Uniti, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, Stati Uniti, 70112
- MBCCOP - LSU Medical Center
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New Orleans, Louisiana, Stati Uniti, 70112
- Veterans Affairs Medical Center - New Orleans
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Shreveport, Louisiana, Stati Uniti, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport, Louisiana, Stati Uniti, 71130
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02118
- Boston Medical Center
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Jamaica Plain, Massachusetts, Stati Uniti, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, Stati Uniti, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Detroit, Michigan, Stati Uniti, 48201
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Stati Uniti, 48202
- Henry Ford Hospital
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Detroit, Michigan, Stati Uniti, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Grand Rapids, Michigan, Stati Uniti, 49503
- CCOP - Grand Rapids Clinical Oncology Program
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Southfield, Michigan, Stati Uniti, 48075-9975
- Providence Hospital - Southfield
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Mississippi
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Biloxi, Mississippi, Stati Uniti, 39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson, Mississippi, Stati Uniti, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, Stati Uniti, 39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB, Mississippi, Stati Uniti, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City, Missouri, Stati Uniti, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, Stati Uniti, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Stati Uniti, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, Stati Uniti, 63141
- CCOP - St. Louis-Cape Girardeau
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Springfield, Missouri, Stati Uniti, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, Stati Uniti, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, Stati Uniti, 87131
- MBCCOP - University of New Mexico HSC
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New York
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New York, New York, Stati Uniti, 10032
- Herbert Irving Comprehensive Cancer Center
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45219
- Barrett Cancer Center, The University Hospital
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Cincinnati, Ohio, Stati Uniti, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cleveland, Ohio, Stati Uniti, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, Stati Uniti, 43206
- CCOP - Columbus
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Dayton, Ohio, Stati Uniti, 45428
- Veterans Affairs Medical Center - Dayton
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Kettering, Ohio, Stati Uniti, 45429
- CCOP - Dayton
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73104
- Oklahoma Medical Research Foundation
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Oklahoma City, Oklahoma, Stati Uniti, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland, Oregon, Stati Uniti, 97201-3098
- Oregon Cancer Center at Oregon Health Sciences University
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Portland, Oregon, Stati Uniti, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, Stati Uniti, 97213
- CCOP - Columbia River Program
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South Carolina
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Greenville, South Carolina, Stati Uniti, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Stati Uniti, 29303
- CCOP - Upstate Carolina
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Texas
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Fort Sam Houston, Texas, Stati Uniti, 78234
- Brooke Army Medical Center
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Galveston, Texas, Stati Uniti, 77555-1329
- University of Texas Medical Branch
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Lubbock, Texas, Stati Uniti, 79423
- Texas Tech University Health Science Center
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San Antonio, Texas, Stati Uniti, 78284-7811
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Stati Uniti, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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Temple, Texas, Stati Uniti, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, Stati Uniti, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, Stati Uniti, 84132
- Huntsman Cancer Institute
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Salt Lake City, Utah, Stati Uniti, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Washington
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Seattle, Washington, Stati Uniti, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, Stati Uniti, 98104
- Swedish Cancer Institute
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Seattle, Washington, Stati Uniti, 98108
- Veterans Affairs Medical Center - Seattle
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Tacoma, Washington, Stati Uniti, 98405-0986
- CCOP - Northwest
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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bone marrow transplant
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standard chemotherapy
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Marilyn L. Slovak, PhD, City of Hope Comprehensive Cancer Center
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CDR0000065813
- U10CA032102 (Sovvenzione/contratto NIH degli Stati Uniti)
- S9719 (Altro identificatore: SWOG)
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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