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Pelvic Mass Study to Develop Serum Proteomic Profiles (SIGNATURES) for Epithelial Ovarian Cancer Diagnosis and Prognosis


N/A
18 Years
N/A
Open (Enrolling)
Female
Fallopian Tube Cancer, Ovarian Cancer

Thank you

Trial Information

Pelvic Mass Study to Develop Serum Proteomic Profiles (SIGNATURES) for Epithelial Ovarian Cancer Diagnosis and Prognosis


OBJECTIVES:

Primary

- Generate and validate a serum proteomic profile that can predict the presence of
invasive ovarian epithelial cancer using preoperative serum specimens obtained from
patients undergoing surgical evaluation for an abnormal pelvic mass.

Secondary

- Generate a proteomic profile that can distinguish early- from late-stage invasive
ovarian epithelial cancer using preoperative serum specimens from patients who are
subsequently diagnosed with invasive ovarian epithelial cancer.

Tertiary

- Determine whether serum proteomic profiling can predict the presence of postoperative
residual disease in these patients.

- Determine whether serum proteomic profiling can predict prognosis in these patients.

OUTLINE: This is a pilot, two-part, multicenter study.

- Part A: Within 3 weeks prior to surgical evaluation, patients undergo collection of
serum specimen for proteomic profiling using surface-enhanced or matrix-associated
laser desorption ionization spectrometry-time of flight detection (SELDI/MALDI-TOF).
Patients then undergo surgical evaluation (i.e., biopsy and/or resection) of the pelvic
mass. Patients who are diagnosed with invasive ovarian epithelial adenocarcinoma or
papillary serous fallopian tube carcinoma (no low malignant potential tumors) AND are
without postoperative infection proceed to part B of the study.

- Part B: Patients undergo collection of postoperative serum specimen for proteomic
profiling using SELDI/MALDI-TOF within 3-8 weeks after surgery, before starting
chemotherapy, and at end of chemotherapy.

After completion of study procedures, patients are followed periodically for up to 10 years.

PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Abnormal pelvic mass by physical examination or imaging test

- Undiagnosed

- Planning to undergo surgical evaluation within the next 3 weeks

PATIENT CHARACTERISTICS:

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Other

- Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Surgery

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Outcome Measure:

Proteomic proflie (i.e. discrimination of tumor from nontumor in pelvic mass)

Safety Issue:

No

Principal Investigator

Elise C. Kohn, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Medical Oncology Branch

Authority:

United States: Federal Government

Study ID:

CDR0000445437

NCT ID:

NCT00238342

Start Date:

October 2005

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • stage I ovarian epithelial cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • fallopian tube cancer
  • ovarian clear cell cystadenocarcinoma
  • ovarian endometrioid adenocarcinoma
  • ovarian mucinous cystadenocarcinoma
  • ovarian serous cystadenocarcinoma
  • ovarian undifferentiated adenocarcinoma
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Carle Cancer CenterUrbana, Illinois  61801
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Seton Cancer Institute - SaginawSaginaw, Michigan  48601
St. John Macomb HospitalWarren, Michigan  48093
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Avera Cancer InstituteSioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Rapid City Regional HospitalRapid City, South Dakota  57709
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
Kaiser Permanente Medical Center - Los AngelesLos Angeles, California  90027
Bayfront Medical CenterSaint Petersburg, Florida  33701
Northwest Community HospitalArlington Heights, Illinois  60005
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
University of Texas Medical BranchGalveston, Texas  77555-1329
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Gynecologic Oncology NetworkGreenville, North Carolina  27858
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
MetroHealth's Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44106
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
CCOP - Scott and White HospitalTemple, Texas  76508
MultiCare Regional Cancer Center at Tacoma General HospitalTacoma, Washington  98405
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
CCOP - NorthwestTacoma, Washington  98405-0986
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Overlook HospitalSummit, New Jersey  07902-0220
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Women's Cancer Center - Las VegasLas Vegas, Nevada  89102
Carol G. Simon Cancer Center at Morristown Memorial HospitalMorristown, New Jersey  07962
SUNY Downstate Medical CenterBrooklyn, New York  11203
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Cancer Care Associates - Midtown TulsaTulsa, Oklahoma  74104
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Carilion Gynecologic Oncology AssociatesRoanoke, Virginia  24014
St. Vincent Indianapolis HospitalIndianapolis, Indiana  46260
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Aultman Hospital Cancer Center at Aultman Health FoundationCanton, Ohio  44710-1799
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
Lakeland Cancer Care Center at Lakeland Hospital - St. JosephSaint Joseph, Michigan  49085
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos Angeles, California  90048-1865
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Elkhart General HospitalElkhart, Indiana  46515
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Lakeland Regional Cancer Center at Lakeland Regional Medical CenterLakeland, Florida  33805
Beebe Medical CenterLewes, Delaware  19958
Howard Community Hospital at Howard Regional Health SystemKokomo, Indiana  46904
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
St. Francis HospitalFederal Way, Washington  98003
St. Clare HospitalLakewood, Washington  98499-0998
Providence St. Peter Hospital Regional Cancer CenterOlympia, Washington  98506
Good Samaritan Cancer CenterPuyallup, Washington  98371
St. Joseph Medical Center at Franciscan Health SystemTacoma, Washington  98405-3004
Allenmore HospitalTacoma, Washington  98411-0414
Washoe Cancer Services at Washoe Medical Center - RenoReno, Nevada  89502
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921
Leo W. Jenkins Cancer Center at ECU Medical SchoolGreenville, North Carolina  27834
Providence Centralia HospitalCentralia, Washington  98531-9027
Highlands Oncology Group - FayettevilleFayetteville, Arkansas  72703
Washington Regional Medical CenterFayetteville, Arkansas  72703
Methodist Cancer Center at Methodist Hospital - OmahaOmaha, Nebraska  68114
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
Auburn Regional Center for Cancer CareAuburn, Washington  98002
University of Virginia Cancer Center at UV Health SystemCharlottesville, Virginia  22908
Metro Health HospitalGrand Rapids, Michigan  49506
Lurleen Wallace Comprehensive Cancer at University of Alabama-BirminghamBirmingham, Alabama  35294
Saint Mary's Regional Medical CenterReno, Nevada  89503
Good Samaritan Hospital Medical CenterWest Islip, New York  11795
Florida Gynecologic Oncology - Fort MyersFort Myers, Florida  33905
Aurora Women's Pavilion of West Allis Memorial HospitalWest Allis, Wisconsin  53227
Williamette Gynecologic Oncology PCPortland, Oregon  97213
Chicago Gynecologic OncologyPalatine, Illinois  60067