- ICH GCP
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- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Alabama
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Mobile, Alabama, Verenigde Staten, 36688
- MBCCOP - University of South Alabama
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85006-2726
- CCOP - Greater Phoenix
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Phoenix, Arizona, Verenigde Staten, 85012
- Veterans Affairs Medical Center - Phoenix (Hayden)
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Tucson, Arizona, Verenigde Staten, 85724
- Arizona Cancer Center
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Tucson, Arizona, Verenigde Staten, 85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, Verenigde Staten, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, Verenigde Staten, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Long Beach, California, Verenigde Staten, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, Verenigde Staten, 90033-0800
- USC/Norris Comprehensive Cancer Center
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Los Angeles, California, Verenigde Staten, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Verenigde Staten, 91010
- Beckman Research Institute, City of Hope
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Martinez, California, Verenigde Staten, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland, California, Verenigde Staten, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, Verenigde Staten, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, Verenigde Staten, 95817
- University of California Davis Medical Center
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Santa Rosa, California, Verenigde Staten, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, Verenigde Staten, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, Verenigde Staten, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, Verenigde Staten, 80262
- University of Colorado Cancer Center
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, Verenigde Staten, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, Verenigde Staten, 96813
- Cancer Research Center of Hawaii
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Illinois
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Decatur, Illinois, Verenigde Staten, 62526
- CCOP - Central Illinois
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Hines, Illinois, Verenigde Staten, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, Verenigde Staten, 60153
- Loyola University Medical Center
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Kansas
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Kansas City, Kansas, Verenigde Staten, 66160-7357
- University of Kansas Medical Center
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Wichita, Kansas, Verenigde Staten, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, Verenigde Staten, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, Verenigde Staten, 40511-1093
- Veterans Affairs Medical Center - Lexington
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Lexington, Kentucky, Verenigde Staten, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Louisiana
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New Orleans, Louisiana, Verenigde Staten, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, Verenigde Staten, 70112
- MBCCOP - LSU Medical Center
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New Orleans, Louisiana, Verenigde Staten, 70112
- Veterans Affairs Medical Center - New Orleans
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Shreveport, Louisiana, Verenigde Staten, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport, Louisiana, Verenigde Staten, 71130
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02118
- Boston Medical Center
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Jamaica Plain, Massachusetts, Verenigde Staten, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, Verenigde Staten, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Detroit, Michigan, Verenigde Staten, 48201
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Verenigde Staten, 48202
- Henry Ford Hospital
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Detroit, Michigan, Verenigde Staten, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Grand Rapids, Michigan, Verenigde Staten, 49503
- CCOP - Grand Rapids Clinical Oncology Program
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Southfield, Michigan, Verenigde Staten, 48075-9975
- Providence Hospital - Southfield
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Mississippi
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Biloxi, Mississippi, Verenigde Staten, 39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson, Mississippi, Verenigde Staten, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, Verenigde Staten, 39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB, Mississippi, Verenigde Staten, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City, Missouri, Verenigde Staten, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, Verenigde Staten, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Verenigde Staten, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, Verenigde Staten, 63141
- CCOP - St. Louis-Cape Girardeau
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Springfield, Missouri, Verenigde Staten, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, Verenigde Staten, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, Verenigde Staten, 87131
- MBCCOP - University of New Mexico HSC
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New York
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New York, New York, Verenigde Staten, 10032
- Herbert Irving Comprehensive Cancer Center
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45219
- Barrett Cancer Center, The University Hospital
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Cincinnati, Ohio, Verenigde Staten, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cleveland, Ohio, Verenigde Staten, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, Verenigde Staten, 43206
- CCOP - Columbus
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Dayton, Ohio, Verenigde Staten, 45428
- Veterans Affairs Medical Center - Dayton
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Kettering, Ohio, Verenigde Staten, 45429
- CCOP - Dayton
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73104
- Oklahoma Medical Research Foundation
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Oklahoma City, Oklahoma, Verenigde Staten, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland, Oregon, Verenigde Staten, 97201-3098
- Oregon Cancer Center at Oregon Health Sciences University
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Portland, Oregon, Verenigde Staten, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, Verenigde Staten, 97213
- CCOP - Columbia River Program
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South Carolina
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Greenville, South Carolina, Verenigde Staten, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Verenigde Staten, 29303
- CCOP - Upstate Carolina
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Texas
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Fort Sam Houston, Texas, Verenigde Staten, 78234
- Brooke Army Medical Center
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Galveston, Texas, Verenigde Staten, 77555-1329
- University of Texas Medical Branch
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Lubbock, Texas, Verenigde Staten, 79423
- Texas Tech University Health Science Center
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San Antonio, Texas, Verenigde Staten, 78284-7811
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Verenigde Staten, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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Temple, Texas, Verenigde Staten, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, Verenigde Staten, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84132
- Huntsman Cancer Institute
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Salt Lake City, Utah, Verenigde Staten, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Washington
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Seattle, Washington, Verenigde Staten, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, Verenigde Staten, 98104
- Swedish Cancer Institute
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Seattle, Washington, Verenigde Staten, 98108
- Veterans Affairs Medical Center - Seattle
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Tacoma, Washington, Verenigde Staten, 98405-0986
- CCOP - Northwest
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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bone marrow transplant
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standard chemotherapy
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Marilyn L. Slovak, PhD, City of Hope Comprehensive Cancer Center
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CDR0000065813
- U10CA032102 (Subsidie/contract van de Amerikaanse NIH)
- S9719 (Andere identificatie: SWOG)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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