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Proteomisk profilering i diagnosticering af ovariecancer hos patienter, der gennemgår kirurgi for en unormal bækkenmasse

6. februar 2010 opdateret af: Gynecologic Oncology Group

Bækkenmasseundersøgelse for at udvikle serumproteomiske profiler (SIGNATURER) til diagnose og prognose af epitelial ovariecancer

RATIONALE: At finde specifikke proteiner i blodet kan hjælpe læger med at fortælle, om en patient har kræft i æggestokkene.

FORMÅL: Dette kliniske forsøg studerer, hvor godt proteomisk profilering virker til at diagnosticere kræft i æggestokkene hos patienter, der skal opereres for en unormal bækkenmasse.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

MÅL:

Primær

Generer og valider en serum proteomisk profil, der kan forudsige tilstedeværelsen af invasiv ovarieepitelcancer ved hjælp af præoperative serumprøver opnået fra patienter, der gennemgår kirurgisk evaluering for en abnorm bækkenmasse.

Sekundær

Generer en proteomisk profil, der kan skelne tidligt fra sent stadium invasiv ovarieepitelcancer ved hjælp af præoperative serumprøver fra patienter, som efterfølgende er diagnosticeret med invasiv ovarieepitelcancer.

Tertiære

Bestem, om serum proteomisk profilering kan forudsige tilstedeværelsen af postoperativ resterende sygdom hos disse patienter.
Bestem, om serum proteomisk profilering kan forudsige prognose hos disse patienter.

OVERSIGT: Dette er et pilotstudie, todelt, multicenter.

Del A: Inden for 3 uger før kirurgisk evaluering gennemgår patienter indsamling af serumprøver til proteomisk profilering ved brug af overfladeforstærket eller matrix-associeret laserdesorptionsioniseringsspektrometri-time of flight-detektion (SELDI/MALDI-TOF). Patienterne gennemgår derefter kirurgisk evaluering (dvs. biopsi og/eller resektion) af bækkenmassen. Patienter, der er diagnosticeret med invasivt ovarieepiteliale adenokarcinom eller papillært serøst æggeledercarcinom (ingen lavt maligne potentielle tumorer) OG er uden postoperativ infektion, fortsætter til del B af undersøgelsen.
Del B: Patienter gennemgår indsamling af postoperativ serumprøve til proteomisk profilering ved brug af SELDI/MALDI-TOF inden for 3-8 uger efter operationen, før start af kemoterapi og ved afslutning af kemoterapi.

Efter afslutning af undersøgelsesprocedurer følges patienterne periodisk i op til 10 år.

PROJEKTERET TILSLUTNING: I alt 2.000 patienter vil blive akkumuleret til denne undersøgelse.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

2000

Fase

Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Alabama
  - Birmingham, Alabama, Forenede Stater, 35294
    - Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
- Arkansas
  - Fayetteville, Arkansas, Forenede Stater, 72703
    - Washington Regional Medical Center
  - Fayetteville, Arkansas, Forenede Stater, 72703
    - Highlands Oncology Group - Fayetteville
- California
  - Burbank, California, Forenede Stater, 91505
    - Providence Saint Joseph Medical Center - Burbank
  - Los Angeles, California, Forenede Stater, 90095-1781
    - Jonsson Comprehensive Cancer Center at UCLA
  - Los Angeles, California, Forenede Stater, 90027
    - Kaiser Permanente Medical Center - Los Angeles
  - Los Angeles, California, Forenede Stater, 90048
    - Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
  - Orange, California, Forenede Stater, 92868
    - Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
- Connecticut
  - New Britain, Connecticut, Forenede Stater, 06050
    - George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
- Delaware
  - Lewes, Delaware, Forenede Stater, 19958
    - Beebe Medical Center
  - Newark, Delaware, Forenede Stater, 19713
    - CCOP - Christiana Care Health Services
- Florida
  - Fort Myers, Florida, Forenede Stater, 33901
    - Florida Gynecologic Oncology - Fort Myers
  - Lakeland, Florida, Forenede Stater, 33805
    - Lakeland Regional Cancer Center at Lakeland Regional Medical Center
  - St. Petersburg, Florida, Forenede Stater, 33701
    - Bayfront Medical Center
- Illinois
  - Arlington Heights, Illinois, Forenede Stater, 60005
    - Northwest Community Hospital
  - Aurora, Illinois, Forenede Stater, 60507
    - Rush-Copley Cancer Care Center
  - Hinsdale, Illinois, Forenede Stater, 60521
    - Hinsdale Hematology Oncology Associates
  - Joliet, Illinois, Forenede Stater, 60435
    - Joliet Oncology-Hematology Associates, Limited - West
  - Palatine, Illinois, Forenede Stater, 60067
    - Chicago Gynecologic Oncology
  - Urbana, Illinois, Forenede Stater, 61801
    - Carle Cancer Center at Carle Foundation Hospital
  - Urbana, Illinois, Forenede Stater, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Elkhart, Indiana, Forenede Stater, 46515
    - Elkhart General Hospital
  - Indianapolis, Indiana, Forenede Stater, 46260
    - St. Vincent Indianapolis Hospital
  - Kokomo, Indiana, Forenede Stater, 46904
    - Howard Community Hospital at Howard Regional Health System
  - La Porte, Indiana, Forenede Stater, 46350
    - Center for Cancer Therapy at LaPorte Hospital and Health Services
  - Michigan City, Indiana, Forenede Stater, 46360
    - Saint Anthony Memorial Health Centers
  - South Bend, Indiana, Forenede Stater, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, Forenede Stater, 46601
    - CCOP - Northern Indiana CR Consortium
  - South Bend, Indiana, Forenede Stater, 46617
    - Saint Joseph Regional Medical Center
- Iowa
  - Iowa City, Iowa, Forenede Stater, 52242
    - Holden Comprehensive Cancer Center at University of Iowa
- Maryland
  - Elkton Md, Maryland, Forenede Stater, 21921
    - Union Hospital Cancer Program at Union Hospital
- Michigan
  - Ann Arbor, Michigan, Forenede Stater, 48106-0995
    - Saint Joseph Mercy Cancer Center
  - Ann Arbor, Michigan, Forenede Stater, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Flint, Michigan, Forenede Stater, 48503
    - Genesys Hurley Cancer Institute
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - Metro Health Hospital
  - Grosse Pointe Woods, Michigan, Forenede Stater, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - Royal Oak, Michigan, Forenede Stater, 48073
    - William Beaumont Hospital - Royal Oak Campus
  - Saginaw, Michigan, Forenede Stater, 48601
    - Seton Cancer Institute - Saginaw
  - St. Joseph, Michigan, Forenede Stater, 49085
    - Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
  - Warren, Michigan, Forenede Stater, 48093
    - St. John Macomb Hospital
- Missouri
  - Kansas City, Missouri, Forenede Stater, 64131
    - CCOP - Kansas City
  - Saint Louis, Missouri, Forenede Stater, 63110
    - Saint Louis University Cancer Center
  - Springfield, Missouri, Forenede Stater, 65802
    - CCOP - Cancer Research for the Ozarks
  - Springfield, Missouri, Forenede Stater, 65804
    - St. John's Regional Health Center
  - Springfield, Missouri, Forenede Stater, 65807
    - Hulston Cancer Center at Cox Medical Center South
  - St Louis, Missouri, Forenede Stater, 63110
    - Siteman Cancer Center at Barnes-Jewish Hospital
- Nebraska
  - Omaha, Nebraska, Forenede Stater, 68198-6805
    - UNMC Eppley Cancer Center at the University of Nebraska Medical Center
  - Omaha, Nebraska, Forenede Stater, 68114
    - Methodist Cancer Center at Methodist Hospital - Omaha
- Nevada
  - Las Vegas, Nevada, Forenede Stater, 89102
    - Women's Cancer Center - Las Vegas
  - Reno, Nevada, Forenede Stater, 89503
    - Saint Mary's Regional Medical Center
  - Reno, Nevada, Forenede Stater, 89502
    - Washoe Cancer Services at Washoe Medical Center - Reno
- New Jersey
  - Marlton, New Jersey, Forenede Stater, 08053
    - Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
  - Morristown, New Jersey, Forenede Stater, 07962
    - Carol G. Simon Cancer Center at Morristown Memorial Hospital
  - Summit, New Jersey, Forenede Stater, 07902
    - Overlook Hospital
  - Voorhees, New Jersey, Forenede Stater, 08043
    - Cancer Institute of New Jersey at Cooper - Voorhees
  - Voorhees, New Jersey, Forenede Stater, 08043
    - Fox Chase Virtua Health Cancer Program at Virtua West Jersey
- New York
  - Brooklyn, New York, Forenede Stater, 11203
    - SUNY Downstate Medical Center
  - Buffalo, New York, Forenede Stater, 14263-0001
    - Roswell Park Cancer Institute
  - West Islip, New York, Forenede Stater, 11795
    - Good Samaritan Hospital Medical Center
- North Carolina
  - Charlotte, North Carolina, Forenede Stater, 28232-2861
    - Blumenthal Cancer Center at Carolinas Medical Center
  - Charlotte, North Carolina, Forenede Stater, 28233-3549
    - Presbyterian Cancer Center at Presbyterian Hospital
  - Durham, North Carolina, Forenede Stater, 27710
    - Duke Comprehensive Cancer Center
  - Greenville, North Carolina, Forenede Stater, 27835-6028
    - Leo W. Jenkins Cancer Center at ECU Medical School
  - Greenville, North Carolina, Forenede Stater, 27834
    - Gynecologic Oncology Network
  - Winston-Salem, North Carolina, Forenede Stater, 27157-1096
    - Wake Forest University Comprehensive Cancer Center
- Ohio
  - Akron, Ohio, Forenede Stater, 44307
    - McDowell Cancer Center at Akron General Medical Center
  - Canton, Ohio, Forenede Stater, 44710-1799
    - Aultman Hospital Cancer Center at Aultman Health Foundation
  - Cincinnati, Ohio, Forenede Stater, 45267
    - Charles M. Barrett Cancer Center at University Hospital
  - Cleveland, Ohio, Forenede Stater, 44195
    - Cleveland Clinic Taussig Cancer Center
  - Cleveland, Ohio, Forenede Stater, 44109
    - MetroHealth's Cancer Care Center at MetroHealth Medical Center
  - Cleveland, Ohio, Forenede Stater, 44106
    - Case Comprehensive Cancer Center
  - Columbus, Ohio, Forenede Stater, 43210-1240
    - Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
  - Columbus, Ohio, Forenede Stater, 43214-3998
    - Riverside Methodist Hospital Cancer Care
  - Dayton, Ohio, Forenede Stater, 45409
    - David L. Rike Cancer Center at Miami Valley Hospital
  - Mentor, Ohio, Forenede Stater, 44060
    - Lake/University Ireland Cancer Center
- Oklahoma
  - Oklahoma City, Oklahoma, Forenede Stater, 73104
    - Oklahoma University Cancer Institute
  - Tulsa, Oklahoma, Forenede Stater, 74104
    - Cancer Care Associates - Midtown Tulsa
- Oregon
  - Portland, Oregon, Forenede Stater, 97213-2967
    - Providence Cancer Center at Providence Portland Medical Center
  - Portland, Oregon, Forenede Stater, 97213
    - Williamette Gynecologic Oncology PC
- Pennsylvania
  - Abington, Pennsylvania, Forenede Stater, 19001
    - Rosenfeld Cancer Center at Abington Memorial Hospital
  - Allentown, Pennsylvania, Forenede Stater, 18105
    - Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
  - Hershey, Pennsylvania, Forenede Stater, 17033-0850
    - Penn State Cancer Institute at Milton S. Hershey Medical Center
  - Philadelphia, Pennsylvania, Forenede Stater, 19111-2497
    - Fox Chase Cancer Center - Philadelphia
  - Philadelphia, Pennsylvania, Forenede Stater, 19104-4283
    - Abramson Cancer Center of the University of Pennsylvania
- Rhode Island
  - Providence, Rhode Island, Forenede Stater, 02905
    - Women and Infants Hospital of Rhode Island
- South Dakota
  - Rapid City, South Dakota, Forenede Stater, 57701
    - Rapid City Regional Hospital
  - Sioux Falls, South Dakota, Forenede Stater, 57105
    - Avera Cancer Institute
- Texas
  - Galveston, Texas, Forenede Stater, 77555-0361
    - University of Texas Medical Branch
  - Temple, Texas, Forenede Stater, 76508
    - CCOP - Scott and White Hospital
- Vermont
  - Burlington, Vermont, Forenede Stater, 05401
    - Fletcher Allen Health Care - University Health Center Campus
- Virginia
  - Charlottesville, Virginia, Forenede Stater, 22908
    - University of Virginia Cancer Center at UV Health System
  - Richmond, Virginia, Forenede Stater, 23298-0037
    - Virginia Commonwealth University Massey Cancer Center
  - Roanoke, Virginia, Forenede Stater, 24014
    - Carilion Gynecologic Oncology Associates
- Washington
  - Auburn, Washington, Forenede Stater, 98002
    - Auburn Regional Center for Cancer Care
  - Centralia, Washington, Forenede Stater, 98531-9027
    - Providence Centralia Hospital
  - Federal Way, Washington, Forenede Stater, 98003
    - St. Francis Hospital
  - Olympia, Washington, Forenede Stater, 98506-5166
    - Providence St. Peter Hospital Regional Cancer Center
  - Puyallup, Washington, Forenede Stater, 98372
    - Good Samaritan Cancer Center
  - Tacoma, Washington, Forenede Stater, 98405
    - Allenmore Hospital
  - Tacoma, Washington, Forenede Stater, 98405
    - CCOP - Northwest
  - Tacoma, Washington, Forenede Stater, 98405
    - MultiCare Regional Cancer Center at Tacoma General Hospital
  - Tacoma, Washington, Forenede Stater, 98499
    - St. Clare Hospital
  - Tacoma, Washington, Forenede Stater, 98405-3004
    - St. Joseph Medical Center at Franciscan Health System
- Wisconsin
  - Green Bay, Wisconsin, Forenede Stater, 54307-3508
    - St. Vincent Hospital Regional Cancer Center
  - La Crosse, Wisconsin, Forenede Stater, 54601
    - Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
  - Madison, Wisconsin, Forenede Stater, 53792-6164
    - University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
  - West Allis, Wisconsin, Forenede Stater, 53227
    - Aurora Women's Pavilion of West Allis Memorial Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (VOKSEN, OLDER_ADULT)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

SYGDOMS KARAKTERISTIKA:

Unormal bækkenmasse ved fysisk undersøgelse eller billeddiagnostisk test
- Udiagnosticeret
Planlægger at gennemgå kirurgisk evaluering inden for de næste 3 uger

PATIENT KARAKTERISTIKA:

Præstationsstatus

Ikke specificeret

Forventede levealder

Ikke specificeret

Hæmatopoietisk

Ikke specificeret

Hepatisk

Ikke specificeret

Renal

Ikke specificeret

Andet

Negativ graviditetstest

FORUDSÆTNING SAMTYDLIG TERAPI:

Kirurgi

Se Sygdomskarakteristika

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: DIAGNOSTISK

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Proteomisk profil (dvs. skelnen mellem tumor og ikke-tumor i bækkenmassen)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Gynecologic Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

Studiestol: Elise C. Kohn, MD, NCI - Medical Oncology Branch
Samir N. Khleif, MD, National Cancer Institute (NCI)
Larry J. Copeland, MD, Ohio State University Comprehensive Cancer Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2005

Primær færdiggørelse (FORVENTET)

1. oktober 2007

Datoer for studieregistrering

Først indsendt

12. oktober 2005

Først indsendt, der opfyldte QC-kriterier