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MammaPrint, BluePrint och full-genomdata kopplade till kliniska data för att utvärdera nya genuttrycksprofiler

MammaPrint-, BluePrint- och full-genomdata kopplade till kliniska data för att utvärdera nya genuttrycksprofiler: ett anpassningsbart register (FLEX)

Sponsorer

Ledande sponsor: Agendia

Källa Agendia
Kort sammanfattning

FLEX-registret kommer att implementeras för att fungera som en storskalig, befolkningsbaserad, blivande register. Alla patienter med stadium I till III bröstcancer som får MammaPrint® och BluePrint -testning på en primär brösttumör är berättigad till inträde i FLEX Registret, som är avsett att möjliggöra ytterligare studiearmar vid låg inkrementell ansträngning och kosta. FLEX Registry kommer att använda en adaptiv design, där ytterligare riktade delstudier och armar kan läggas till efter att den första studien har öppnats.

detaljerad beskrivning

FLEX-registret kommer att omfatta alla patienter med bröstcancer i stadium I-III som har fått MammaPrint och BluePrint -testning i alla kliniska miljöer. Studierarms bilagor kommer att specificera behandlingsarm, inkluderingskriterier och antal patienter som behövs. Cirka 25 000 patienter från 125+ amerikanska institutioner kommer att registreras. Behandlingen sker efter bedömning av läkaren som följer NCCN -godkända behandlingar av a erkänt alternativ. Klinisk data kommer att samlas in och läggas in online på de angivna tidpunkterna: patient registrering, behandlingstid, 1 år efter behandling och 3, 5 och 10 år efter diagnos. Mål: - Skapa ett storskaligt, befolkningsbaserat register över fullständiga genomuttrycksdata och kliniska data för att undersöka nya genföreningar med prognostiska och/eller prediktiva värde - Använd delad registerinfrastruktur för att undersöka mindre intressegrupper - Generera hypoteser för riktade delmängdsanalyser och försök baserade på fullständiga genomdata FLEX är en observationsstudie (fas IV).

Övergripande status Rekrytering
Start datum 2017-04-28
Slutförelsedatum 2030-12-01
Primärt slutdatum 2030-04-01
Studietyp Observations [Patientregister]
Primärt resultat
Mäta Tidsram
A large scale registry of full genome expression data to investigate new gene associations with prognostic and/or predictive value will be created. 10 years
En gemensam registerinfrastruktur för att undersöka mindre intressegrupper. Morcilla
Sekundärt resultat
Mäta Tidsram
Delmängdsanalyser baserade på fullständiga genomdata kommer att skapas. Morcilla
Inskrivning 25000
Tillstånd
Intervention

Interventionstyp: Diagnostiskt test

Interventionens namn: MammaPrint, BluePrint och Full-Genome Testing

Beskrivning: Agendia kommer att köra MammaPrint och BluePrint -tester med hela genomtestmatrisen.

Arm Group-etikett: MammaPrint och BluePrint test

Annat namn: MammaPrint, BluePrint

Behörighet

Testmetod:

Icke-sannolikhetsprov

Kriterier:

Inklusionskriterier: - Steg I, II eller III patienter som får MammaPrint, med eller utan BluePrint -test (man eller kvinna) - Informerat samtyckeformulär undertecknat samma dag eller före inskrivning - Ny primär lesion Exklusions kriterier: - Tumörprov skickat till Agendia med ≤ 30% tumörceller eller som inte uppfyller QA- eller QC -kriterier - Metastatisk sjukdom - Återkommande sjukdom - Steg 0 -sjukdom

Kön:

Allt

Lägsta ålder:

18 år

Högsta ålder:

Ej tillgängligt

Friska volontärer:

Nej

Övergripande officiell
Övergripande kontakt

Efternamn: Christine Finn

Telefon: 517-242-4181

E-post: [email protected]

Plats
Anläggning: Status: Kontakt: Forskare:
CHS Grandview | Birmingham, Alabama, 35243, United States Recruiting Lisa Clemons [email protected] Jennifer De Los Santos, MD Principal Investigator
Arizona Oncology Associates, PC - HOPE | Tucson, Arizona, 85704, United States Recruiting Julie Klinker [email protected] Rachel Swart, MD Principal Investigator
Comprehensive Cancer Center at Desert Regional Medical Center | Palm Springs, California, 92262, United States Recruiting Claudia Fortiche [email protected] Laura Lee, MD Principal Investigator
North Valley Breast Clinic | Redding, California, 96001, United States Recruiting Ian Grady, MD 530-243-5551 Ian P Grady, MD Principal Investigator
UCSF Breast Care Center | San Francisco, California, 94158, United States Recruiting Katherine Leggat-Barr [email protected] Rita Mukhtar, MD Principal Investigator Laura Esserman, MD Principal Investigator
Valley Breast Care | Van Nuys, California, 91405, United States Recruiting James Dunham [email protected] Thomas Lomis, MD Principal Investigator
Rocky Mountain Cancer Centers | Aurora, Colorado, 80012, United States Recruiting Wafa El-Ejmi [email protected] Sami Diab, MD Principal Investigator
Comprehensive Breast Care of Denver | Denver, Colorado, 80218, United States Recruiting Joseph Ruybal, MA [email protected] Julie Barone, MD Principal Investigator
Rocky Mountain Cancer Center - Lakewood | Lakewood, Colorado, 80228, United States Recruiting Sami Diab, MD Principal Investigator
Vail Health - Shaw Cancer Center | Vail, Colorado, 81658, United States Recruiting Paige Bordelon [email protected] Julie Barone, DO Principal Investigator
St. Mary's Hospital | Waterbury, Connecticut, 06706, United States Recruiting Jessica Bello [email protected] Beth Sieling, MD Principal Investigator
Medical Oncology and Hematology Consultants | Newark, Delaware, 19713, United States Recruiting Julie Yucis [email protected] Jamal Misleh, MD Principal Investigator
Breast Specialists of South Florida | Atlantis, Florida, 33462, United States Recruiting Chris Lawton [email protected] June Lee, MD Principal Investigator
JFK Medical Center | Atlantis, Florida, 33462, United States Recruiting Tonnica Sasanas, RN, BSN 561-548-1877 [email protected] June Lee, MD Principal Investigator
Boca Raton Regional Hospital | Boca Raton, Florida, 33428, United States Recruiting Maggie Szymczak [email protected] Jane Skelton, MD Principal Investigator
Morton Plant Hospital | Clearwater, Florida, 33756, United States Recruiting Debra Ellis, RN 727-461-8526 [email protected] Peter Blumencranz, MD Principal Investigator
Halifax Health - Center for Oncology | Daytona Beach, Florida, 32114, United States Recruiting Deborah Reynolds [email protected] Ruby Anne Deveras, MD Principal Investigator
Baptist MD Anderson Cancer Center | Jacksonville, Florida, 32207, United States Recruiting Mila Shteyn, MA 904-202-7072 Jennifer Crozier, MD Principal Investigator
University of Florida - Jacksonville | Jacksonville, Florida, 32224, United States Recruiting Tarra Ullig [email protected] Shahla Masood, MD Principal Investigator
St. Vincent Hospital / Mayo Clinic | Jacksonville, Florida, 32256, United States Recruiting Tabetha Gayton [email protected] Pooja Advani, MD Principal Investigator
Lakeland Regional Cancer Center | Lakeland, Florida, 33805, United States Recruiting Rebecca Delph [email protected] Madhavi Venigalla, MD Principal Investigator
Sylvester Comprehensive Cancer Center - University of Miami | Miami, Florida, 33136, United States Recruiting Teresa Torres [email protected] Reshma L Mahtani, MD Principal Investigator
Cancer Care Centers of Brevard | Rockledge, Florida, 32955, United States Recruiting Deborah Schmitt [email protected] Pavan Kancharla, MD Principal Investigator
St. Joseph's Hospital - Baycare | Tampa, Florida, 33607, United States Recruiting Jennifer Boyd [email protected] Robert Gabordi, MD Principal Investigator
University of South Florida | Tampa, Florida, 33613, United States Recruiting Khattiya Chharath [email protected] Charles Cox, MD Principal Investigator
Winter Haven Hospital | Winter Haven, Florida, 33881, United States Recruiting Jan Bauer, RN 863-293-1121 5872 [email protected] Kamal Sharma, DO Principal Investigator
Phoebe Health | Albany, Georgia, 31701, United States Recruiting Keisa Mansfield [email protected]
Piedmont Cancer Institute | Atlanta, Georgia, 30318, United States Recruiting Trevor Feinstein, MD Principal Investigator
Emory University - Winship Cancer Institute | Atlanta, Georgia, 30322, United States Recruiting Alicia Escobar [email protected] Cathy Graham, MD Principal Investigator
Southeast Georgia Health System - Physician Associates | Brunswick, Georgia, 31520, United States Recruiting Gwen Gratto-Cox [email protected] Antonio Moran, Jr., MD Principal Investigator
DeKalb Medical Center | Decatur, Georgia, 30033, United States Recruiting Ruthie Sweat [email protected] Jayanthi Srinivasiah, MD Principal Investigator
Tift Regional Health System | Tifton, Georgia, 31794, United States Recruiting Jodie Davis, RN 229-353-3730 [email protected] Apurva Shah, MD Principal Investigator
University of Illinois at Chicago | Chicago, Illinois, 60612, United States Recruiting Darlene Kitterman [email protected] VK Gadi, MD Principal Investigator
Alexian Brothers Medical Center | Elk Grove Village, Illinois, 60007, United States Recruiting Lauren Niklinski [email protected] Robert Maganini, MD Principal Investigator
Saint Alexius Medical Center | Hoffman Estates, Illinois, 60169, United States Recruiting Lauren Niklinski [email protected] Robert Maganini, MD Principal Investigator
Affiliated Oncologists | Oak Lawn, Illinois, 60453, United States Recruiting Amy Brich [email protected] Rami Haddad, MD Principal Investigator
Parkview Health | Fort Wayne, Indiana, 46805, United States Recruiting Emily Powell [email protected] Linda Han, MD Principal Investigator
American Health Network | Muncie, Indiana, 47304, United States Recruiting Kisha Horan [email protected] Fadi Hayek, MD Principal Investigator
Louisiana State University | New Orleans, Louisiana, 70112, United States Completed
Mercy Medical Center | Baltimore, Maryland, 21202, United States Recruiting Lisa McConnell [email protected] David Riseberg, MD Principal Investigator
Johns Hopkins Hospital | Baltimore, Maryland, 21231, United States Recruiting Nivali Naik [email protected] Mehran Habibi, MD Principal Investigator
Maryland Oncology Hematology - Bethesda | Bethesda, Maryland, 20817, United States Recruiting Carolyn Hendricks, MD Principal Investigator
Maryland Oncology Hematology - Brandywine | Brandywine, Maryland, 20613, United States Recruiting Carolyn Hendricks, MD Principal Investigator
Maryland Oncology Hematology - Clinton | Clinton, Maryland, 20735, United States Recruiting Carolyn Hendricks, MD Principal Investigator
Maryland Oncology Hematology, PA | Columbia, Maryland, 21044, United States Recruiting Carolyn Hendricks, MD Principal Investigator
UPMC at Western Maryland Health System | Cumberland, Maryland, 21502, United States Recruiting Mildred Seletyn [email protected] Blanche Mavromatis, MD Principal Investigator
Frederick Oncology Hematology Associates | Frederick, Maryland, 21702, United States Recruiting Carolyn Hendricks, MD Principal Investigator
Maryland Oncology Hematology - Aquilino Cancer Center | Rockville, Maryland, 20850, United States Recruiting Carolyn Hendricks, MD Principal Investigator
Maryland Oncology Hematology, PA | Silver Spring, Maryland, 20904, United States Recruiting Carolyn Hendricks, MD Principal Investigator
Mercy Medical Center | Springfield, Massachusetts, 01104, United States Completed
St. John Hospital | Grosse Pointe Woods, Michigan, 48236, United States Recruiting Margaret van der Veen, RN 313-343-4657 [email protected] Carrie Dul, MD Principal Investigator
Sparrow Cancer Center | Lansing, Michigan, 48912, United States Recruiting Harsha Trivedi [email protected] Gordan Srkalovic, MD Principal Investigator
Providence - Providence Park Hospital | Southfield, Michigan, 48075, United States Completed
Minnesota Oncology | Minneapolis, Minnesota, 55404, United States Recruiting Anne Rabenn [email protected] Michaela Tsai, MD Principal Investigator
Boone Hospital Center | Columbia, Missouri, 65201, United States Recruiting Mihaela Popescu [email protected] Anne Petersen, MD Principal Investigator
Washington University School of Medicine | Saint Louis, Missouri, 63110, United States Recruiting Isabella Grigsby [email protected] Cynthia Ma, MD PhD Principal Investigator
New York Oncology Hematology | Albany, New York, 12206, United States Recruiting Josephine Faruol [email protected] Karen Tedesco, MD Principal Investigator
Broome Oncology | Binghamton, New York, 13905, United States Recruiting Eswar Pinnamaneni [email protected] Joseph Potz, MD Principal Investigator
Roswell Park Cancer Institute | Buffalo, New York, 14263, United States Recruiting Karen Rudnicki [email protected] Ellis Levine, MD Principal Investigator
Lake Success Oncology / ProHealth Care | Lake Success, New York, 11020, United States Recruiting Desiree Grogan [email protected] Margaret Chen, MD Principal Investigator
NYU Winthrop Hospital | Mineola, New York, 11501, United States Recruiting Farrah Covington, RN 516-663-1237 [email protected] Nina D'Abreo, MD Principal Investigator
Northwell Health- Northern Westchester Hospital | Mount Kisco, New York, 10549, United States Recruiting Julissa Cruz [email protected] Pond Keleman, MD Principal Investigator
Hematology Oncology Center of Rockland at Nyack | Nyack, New York, 10960, United States Recruiting Marion VanWoudenberg [email protected] Sung Ho Lee, MD Principal Investigator
University of Rochester - Pluta Cancer Center | Rochester, New York, 14642, United States Recruiting Katherine Gerich [email protected] Ajay Dhakal, MD Principal Investigator
SUNY Upstate Medical University Hospital | Syracuse, New York, 13210, United States Recruiting Erinn McDowell [email protected] Abirami Sivapiragasam, MD Principal Investigator
Northwell Health- Phelps Hospital | Tarrytown, New York, 10591, United States Recruiting Julissa Cruz 914-362-6277 [email protected] Pond Kelemen Principal Investigator
Akron General Medical Center | Akron, Ohio, 44307, United States Recruiting Michael McNeal [email protected] Esther Rehmus Principal Investigator
TriHealth Cancer Institutes | Cincinnati, Ohio, 45220, United States Recruiting Nancy Firsich, RN, BSN 513-865-5569 [email protected] Apurva Mehta, MD Principal Investigator
Cancer Centers of Southwest Oklahoma | Lawton, Oklahoma, 73505, United States Completed
Oregon Health and Science University | Portland, Oregon, 97210, United States Recruiting Nick Coddington [email protected] Jacqueline Vuky, MD Principal Investigator
St. Luke's Hospital | Bethlehem, Pennsylvania, 18015, United States Recruiting Lauren Downing [email protected] Lee Riley, MD Principal Investigator
St. Mary Medical Center | Langhorne, Pennsylvania, 19047, United States Terminated
Allegheny Health Network | Pittsburgh, Pennsylvania, 15212, United States Recruiting Donna Creese [email protected] Diane Buchbarker, MD Principal Investigator
University of Pittsburgh Medical Centers | Pittsburgh, Pennsylvania, 15213, United States Recruiting Christine Thomas [email protected] Adam Brufsky, MD, PhD Principal Investigator
Grandview Hospital | Sellersville, Pennsylvania, 18960, United States Completed
Roper St. Francis Physician Partners - Breast Surgery | Charleston, South Carolina, 29401, United States Recruiting Courtney O'Neill Roldan, MHA [email protected] Megan Baker, MD Principal Investigator
Tidelands Health Coastal Carolina Breast Center | Georgetown, South Carolina, 29442, United States Recruiting Barbara Roe [email protected] Angela Mislowsky, MD Principal Investigator
Nashville Breast Center | Nashville, Tennessee, 37203, United States Recruiting Kristie Appleton 615-620-5535 Pat W Whitworth, MD Principal Investigator
Texas Oncology - Allen | Allen, Texas, 75013, United States Recruiting Tejvir Anand [email protected] Monte Jones, MD Principal Investigator
Harrington Cancer Center | Amarillo, Texas, 79106, United States Recruiting Gina Cravey [email protected] Brian Pruitt, MD Principal Investigator
Texas Oncology - Bedford | Bedford, Texas, 76022, United States Recruiting Sandy Mathews [email protected]y.com Lea Krekow, MD Principal Investigator
Texas Oncology - Carrollton | Carrollton, Texas, 75010, United States Recruiting Whitney Koracin [email protected] Vibha Thomas, MD Principal Investigator
CHRISTUS Spohn Cancer Center | Corpus Christi, Texas, 78404, United States Recruiting Polly Mock [email protected] Shantan Reddy, MD Principal Investigator
Texas Oncology - Methodist Dallas Cancer Center | Dallas, Texas, 75203, United States Recruiting Atisha Manhas, MD Principal Investigator
Texas Oncology - Presbyterian | Dallas, Texas, 75231, United States Recruiting Kristi McIntyre, MD Principal Investigator
Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas, Texas, 75246, United States Recruiting Teinette Wells [email protected] Joyce O'Shaughnessy, MD Principal Investigator
Texas Oncology - Denton | Denton, Texas, 76210, United States Recruiting Nancy Smith [email protected] Sharad Jain, MD Principal Investigator
Texas Oncology - Flower Mound | Flower Mound, Texas, 75028, United States Recruiting Whitney Koracin [email protected] Vibha Thomas, MD Principal Investigator
The Center for Cancer and Blood Disorders | Fort Worth, Texas, 76104, United States Recruiting Melissa Pool [email protected] Robyn Young, MD Principal Investigator
Texas Oncology - Grapevine | Grapevine, Texas, 76051, United States Recruiting Sandy Mathews [email protected] Lea Krekow, MD Principal Investigator
Texas Oncology - Memorial City | Houston, Texas, 77024, United States Recruiting Rowena Martinez [email protected] Michelina Cairo, MD Principal Investigator
Oncology Consultants | Katy, Texas, 77494, United States Active, not recruiting
University of Texas Medical Branch | League City, Texas, 77573, United States Recruiting Lisa Hernandez Garcia [email protected] V. Suzanne Klimberg, MD Principal Investigator
Texas Oncology - Longview | Longview, Texas, 75601, United States Recruiting Svetislava Vukelja, MD Principal Investigator
Texas Tech UHSC - Southwest Cancer Center | Lubbock, Texas, 79430, United States Recruiting Melanie Bisbee [email protected] Rakhshanda Layeequr-Rahman, MD Principal Investigator
Texas Oncology - McKinney | McKinney, Texas, 75071, United States Recruiting Tejvir Anand [email protected] Monte Jones, MD Principal Investigator
Texas Oncology - Plano East | Plano, Texas, 75075, United States Recruiting Christopher Stokoe, MD Principal Investigator
Texas Oncology - Plano West | Plano, Texas, 95093, United States Recruiting Tejvir Anand [email protected] Philip Kovoor, MD Principal Investigator
Texas Oncology, PA - Metropolitan | San Antonio, Texas, 78212, United States Recruiting Emmalind Aponte, MD Principal Investigator
Texas Oncology, PA - Northeast | San Antonio, Texas, 78217, United States Recruiting Emmalind Aponte, MD Principal Investigator
UT Health Cancer Center | San Antonio, Texas, 78229, United States Recruiting Lacey McClure [email protected] Virginia Kaklamani, MD Principal Investigator
Texas Oncology PA -San Antonio Medical Center | San Antonio, Texas, 78240, United States Recruiting Emmalind Aponte, MD Principal Investigator
Texas Oncology, PA - Stone Oak | San Antonio, Texas, 78258, United States Recruiting Emmalind Aponte, MD Principal Investigator
Texas Oncology - Tyler | Tyler, Texas, 75702, United States Recruiting Svetislava Vukelja, MD Principal Investigator
Texas Oncology - Waco | Waco, Texas, 76712, United States Recruiting Laura Fonseca [email protected] Carlos Encarnacion, MD Principal Investigator
Texas Oncology - Webster | Webster, Texas, 77584, United States Recruiting Dhatri Kodali, MD Principal Investigator
Ogden Regional Cancer Center | Ogden, Utah, 84405, United States Recruiting Brittny Miller [email protected] Jose Tomayo, MD Principal Investigator
Seattle Cancer Care Alliance | Seattle, Washington, 98109, United States Recruiting Obsy Tadesse [email protected] Natasha Hunter, MD Principal Investigator
Columbia St. Mary's | Milwaukee, Wisconsin, 53211, United States Recruiting Bobby Paul [email protected] Varsha Shah, MD Principal Investigator
Platsländer

United States

Verifieringsdatum

2021-10-01

Ansvarig part

Typ: Sponsor

Nyckelord
Har utökad åtkomst Nej
Arm Group

Märka: MammaPrint och BluePrint test

Beskrivning: Alla patienter kommer att få MammaPrint- och BluePrint-testning med hjälp av full-genom-testdatachipet. Behandlingen sker efter läkarens bedömning medan NCCN: s riktlinjer följs.

Akronym FLEX
Information om studiedesign

Observationsmodell: Endast fall

Tidsperspektiv: Blivande

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