- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Alabama
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Mobile, Alabama, États-Unis, 36688
- MBCCOP - University of South Alabama
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Arizona
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Phoenix, Arizona, États-Unis, 85006-2726
- CCOP - Greater Phoenix
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Phoenix, Arizona, États-Unis, 85012
- Veterans Affairs Medical Center - Phoenix (Hayden)
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Tucson, Arizona, États-Unis, 85724
- Arizona Cancer Center
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Tucson, Arizona, États-Unis, 85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, États-Unis, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, États-Unis, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Long Beach, California, États-Unis, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, États-Unis, 90033-0800
- USC/Norris Comprehensive Cancer Center
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Los Angeles, California, États-Unis, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, États-Unis, 91010
- Beckman Research Institute, City of Hope
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Martinez, California, États-Unis, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland, California, États-Unis, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, États-Unis, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, États-Unis, 95817
- University of California Davis Medical Center
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Santa Rosa, California, États-Unis, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, États-Unis, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, États-Unis, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, États-Unis, 80262
- University of Colorado Cancer Center
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Georgia
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Atlanta, Georgia, États-Unis, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, États-Unis, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, États-Unis, 96813
- Cancer Research Center of Hawaii
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Illinois
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Decatur, Illinois, États-Unis, 62526
- CCOP - Central Illinois
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Hines, Illinois, États-Unis, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, États-Unis, 60153
- Loyola University Medical Center
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Kansas
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Kansas City, Kansas, États-Unis, 66160-7357
- University of Kansas Medical Center
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Wichita, Kansas, États-Unis, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, États-Unis, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, États-Unis, 40511-1093
- Veterans Affairs Medical Center - Lexington
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Lexington, Kentucky, États-Unis, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Louisiana
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New Orleans, Louisiana, États-Unis, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, États-Unis, 70112
- MBCCOP - LSU Medical Center
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New Orleans, Louisiana, États-Unis, 70112
- Veterans Affairs Medical Center - New Orleans
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Shreveport, Louisiana, États-Unis, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport, Louisiana, États-Unis, 71130
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston, Massachusetts, États-Unis, 02118
- Boston Medical Center
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Jamaica Plain, Massachusetts, États-Unis, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, États-Unis, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Detroit, Michigan, États-Unis, 48201
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, États-Unis, 48202
- Henry Ford Hospital
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Detroit, Michigan, États-Unis, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Grand Rapids, Michigan, États-Unis, 49503
- CCOP - Grand Rapids Clinical Oncology Program
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Southfield, Michigan, États-Unis, 48075-9975
- Providence Hospital - Southfield
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Mississippi
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Biloxi, Mississippi, États-Unis, 39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson, Mississippi, États-Unis, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, États-Unis, 39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB, Mississippi, États-Unis, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City, Missouri, États-Unis, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, États-Unis, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, États-Unis, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, États-Unis, 63141
- CCOP - St. Louis-Cape Girardeau
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Springfield, Missouri, États-Unis, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, États-Unis, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, États-Unis, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, États-Unis, 87131
- MBCCOP - University of New Mexico HSC
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New York
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New York, New York, États-Unis, 10032
- Herbert Irving Comprehensive Cancer Center
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Ohio
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Cincinnati, Ohio, États-Unis, 45219
- Barrett Cancer Center, The University Hospital
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Cincinnati, Ohio, États-Unis, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cleveland, Ohio, États-Unis, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, États-Unis, 43206
- CCOP - Columbus
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Dayton, Ohio, États-Unis, 45428
- Veterans Affairs Medical Center - Dayton
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Kettering, Ohio, États-Unis, 45429
- CCOP - Dayton
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73104
- Oklahoma Medical Research Foundation
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Oklahoma City, Oklahoma, États-Unis, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland, Oregon, États-Unis, 97201-3098
- Oregon Cancer Center at Oregon Health Sciences University
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Portland, Oregon, États-Unis, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, États-Unis, 97213
- CCOP - Columbia River Program
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South Carolina
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Greenville, South Carolina, États-Unis, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, États-Unis, 29303
- CCOP - Upstate Carolina
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Texas
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Fort Sam Houston, Texas, États-Unis, 78234
- Brooke Army Medical Center
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Galveston, Texas, États-Unis, 77555-1329
- University of Texas Medical Branch
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Lubbock, Texas, États-Unis, 79423
- Texas Tech University Health Science Center
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San Antonio, Texas, États-Unis, 78284-7811
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, États-Unis, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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Temple, Texas, États-Unis, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, États-Unis, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, États-Unis, 84132
- Huntsman Cancer Institute
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Salt Lake City, Utah, États-Unis, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Washington
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Seattle, Washington, États-Unis, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, États-Unis, 98104
- Swedish Cancer Institute
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Seattle, Washington, États-Unis, 98108
- Veterans Affairs Medical Center - Seattle
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Tacoma, Washington, États-Unis, 98405-0986
- CCOP - Northwest
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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bone marrow transplant
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standard chemotherapy
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Marilyn L. Slovak, PhD, City of Hope Comprehensive Cancer Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CDR0000065813
- U10CA032102 (Subvention/contrat des NIH des États-Unis)
- S9719 (Autre identifiant: SWOG)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Cancer du sein
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