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.
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Alabama
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Mobile、Alabama、美国、36688
- MBCCOP - University of South Alabama
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Arizona
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Phoenix、Arizona、美国、85006-2726
- CCOP - Greater Phoenix
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Phoenix、Arizona、美国、85012
- Veterans Affairs Medical Center - Phoenix (Hayden)
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Tucson、Arizona、美国、85724
- Arizona Cancer Center
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Tucson、Arizona、美国、85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock、Arkansas、美国、72205
- University of Arkansas for Medical Sciences
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Little Rock、Arkansas、美国、72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Long Beach、California、美国、90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles、California、美国、90033-0800
- USC/Norris Comprehensive Cancer Center
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Los Angeles、California、美国、90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles、California、美国、91010
- Beckman Research Institute, City of Hope
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Martinez、California、美国、94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland、California、美国、94609-3305
- CCOP - Bay Area Tumor Institute
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Orange、California、美国、92868
- Chao Family Comprehensive Cancer Center
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Sacramento、California、美国、95817
- University of California Davis Medical Center
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Santa Rosa、California、美国、95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base、California、美国、94535
- David Grant Medical Center
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Colorado
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Denver、Colorado、美国、80220
- Veterans Affairs Medical Center - Denver
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Denver、Colorado、美国、80262
- University of Colorado Cancer Center
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Georgia
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Atlanta、Georgia、美国、30342-1701
- CCOP - Atlanta Regional
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Fort Gordon、Georgia、美国、30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu、Hawaii、美国、96813
- Cancer Research Center of Hawaii
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Illinois
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Decatur、Illinois、美国、62526
- CCOP - Central Illinois
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Hines、Illinois、美国、60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood、Illinois、美国、60153
- Loyola University Medical Center
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Kansas
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Kansas City、Kansas、美国、66160-7357
- University of Kansas Medical Center
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Wichita、Kansas、美国、67214-3882
- CCOP - Wichita
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Wichita、Kansas、美国、67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington、Kentucky、美国、40511-1093
- Veterans Affairs Medical Center - Lexington
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Lexington、Kentucky、美国、40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Louisiana
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New Orleans、Louisiana、美国、70112
- Tulane University School of Medicine
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New Orleans、Louisiana、美国、70112
- MBCCOP - LSU Medical Center
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New Orleans、Louisiana、美国、70112
- Veterans Affairs Medical Center - New Orleans
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Shreveport、Louisiana、美国、71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport、Louisiana、美国、71130
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston、Massachusetts、美国、02118
- Boston Medical Center
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Jamaica Plain、Massachusetts、美国、02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor、Michigan、美国、48109-0752
- University of Michigan Comprehensive Cancer Center
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Ann Arbor、Michigan、美国、48105
- Veterans Affairs Medical Center - Ann Arbor
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Detroit、Michigan、美国、48201
- Barbara Ann Karmanos Cancer Institute
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Detroit、Michigan、美国、48202
- Henry Ford Hospital
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Detroit、Michigan、美国、48201-1932
- Veterans Affairs Medical Center - Detroit
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Grand Rapids、Michigan、美国、49503
- CCOP - Grand Rapids Clinical Oncology Program
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Southfield、Michigan、美国、48075-9975
- Providence Hospital - Southfield
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Mississippi
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Biloxi、Mississippi、美国、39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson、Mississippi、美国、39216-4505
- University of Mississippi Medical Center
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Jackson、Mississippi、美国、39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB、Mississippi、美国、39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City、Missouri、美国、64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City、Missouri、美国、64131
- CCOP - Kansas City
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Saint Louis、Missouri、美国、63110-0250
- St. Louis University Health Sciences Center
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Saint Louis、Missouri、美国、63141
- CCOP - St. Louis-Cape Girardeau
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Springfield、Missouri、美国、65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings、Montana、美国、59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque、New Mexico、美国、87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque、New Mexico、美国、87131
- MBCCOP - University of New Mexico HSC
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New York
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New York、New York、美国、10032
- Herbert Irving Comprehensive Cancer Center
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Ohio
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Cincinnati、Ohio、美国、45219
- Barrett Cancer Center, The University Hospital
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Cincinnati、Ohio、美国、45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cleveland、Ohio、美国、44195
- Cleveland Clinic Taussig Cancer Center
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Columbus、Ohio、美国、43206
- CCOP - Columbus
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Dayton、Ohio、美国、45428
- Veterans Affairs Medical Center - Dayton
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Kettering、Ohio、美国、45429
- CCOP - Dayton
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Oklahoma
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Oklahoma City、Oklahoma、美国、73104
- Oklahoma Medical Research Foundation
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Oklahoma City、Oklahoma、美国、73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland、Oregon、美国、97201-3098
- Oregon Cancer Center at Oregon Health Sciences University
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Portland、Oregon、美国、97207
- Veterans Affairs Medical Center - Portland
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Portland、Oregon、美国、97213
- CCOP - Columbia River Program
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South Carolina
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Greenville、South Carolina、美国、29615
- CCOP - Greenville
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Spartanburg、South Carolina、美国、29303
- CCOP - Upstate Carolina
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Texas
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Fort Sam Houston、Texas、美国、78234
- Brooke Army Medical Center
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Galveston、Texas、美国、77555-1329
- University of Texas Medical Branch
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Lubbock、Texas、美国、79423
- Texas Tech University Health Science Center
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San Antonio、Texas、美国、78284-7811
- University of Texas Health Science Center at San Antonio
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San Antonio、Texas、美国、78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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Temple、Texas、美国、76504
- Veterans Affairs Medical Center - Temple
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Temple、Texas、美国、76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City、Utah、美国、84132
- Huntsman Cancer Institute
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Salt Lake City、Utah、美国、84148
- Veterans Affairs Medical Center - Salt Lake City
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Washington
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Seattle、Washington、美国、98101
- CCOP - Virginia Mason Research Center
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Seattle、Washington、美国、98104
- Swedish Cancer Institute
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Seattle、Washington、美国、98108
- Veterans Affairs Medical Center - Seattle
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Tacoma、Washington、美国、98405-0986
- CCOP - Northwest
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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bone marrow transplant
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standard chemotherapy
|
合作者和调查者
调查人员
- 学习椅:Marilyn L. Slovak, PhD、City of Hope Comprehensive Cancer Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.