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| Sponsor: | Fujirebio Diagnostics, Inc. |
|---|---|
| Collaborators: |
Advanced Clinical Research Services, LLC ReSearch Pharmaceutical Services, Inc. |
| Information provided by: | Fujirebio Diagnostics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00987649 |
Purpose
The purpose of this study is to determine whether the Risk of Ovarian Cancer Algorithm (ROMA) is effective in the determination of a woman's risk of cancer when she is scheduled to have surgery to remove a pelvic mass.
After Informed Consent is obtained, an Initial Cancer Risk Assessment will be made. A blood sample will be collected within 30 days of the surgical procedure. Results of the surgical procedure will be collected and analyzed against the CA125 and HE4 results used in the calculation of the ROMA.
| Condition |
|---|
|
Adnexal Mass Ovarian Cancer |
| Study Type: | Observational |
| Study Design: | Case-Only, Prospective |
| Official Title: | Evaluation of CA125 and HE4 Assays to Estimate the Risk of Ovarian Cancer in Patients Presenting to a General Surgeon or Obstetrician/Gynecologist With an Adnexal Mass |
Serum, Plasma, Urine
| Estimated Enrollment: | 525 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | May 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
It is anticipated that approximately 10 general or specialty centers geographically dispersed throughout the United States will be utilized.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Paula S Renneisen | 610.240.3927 | renneisenp@fdi.com |
| Contact: Katherine Falcone | 610.240.3864 | falconek@fdi.com |
| United States, California | |
| Scripps Clinic Carmel Valley | Recruiting |
| San Diego, California, United States, 92130 | |
| Contact: Nancy Giovanetty, CMA, CRC 858-764-3023 giovanetty.nancy@scrippshealth.org | |
| Principal Investigator: Bruce S Kahn, MD, FACOG | |
| United States, Florida | |
| OB/GYN Specialists of the Palm Beaches | Not yet recruiting |
| Jupiter, Florida, United States, 33458 | |
| Contact: Jennifer Schindel, RN, CCRC 561-802-5331 jschindel@ogspb.com | |
| Contact: Joanne Lutz, RN, CCRC 561.802.5331 jlutz@ogspb.com | |
| Principal Investigator: Donna M Pinelli, MD | |
| University of South Florida Medical Center | Not yet recruiting |
| Tampa, Florida, United States, 33606 | |
| Contact: Caroline Young, MSN, ARNP 813-259-8685 cayoung@health.usf.edu | |
| Principal Investigator: Anna Parsons, MD | |
| United States, Louisiana | |
| Woman's Hospital | Not yet recruiting |
| Baton Rouge, Louisiana, United States, 70815 | |
| Contact: Shonta' Wallace 225-231-5656 SHONTA.WALLACE@womans.org | |
| Principal Investigator: Beverly Ogden, MD | |
| United States, North Carolina | |
| New Hanover Regional Medical Center | Not yet recruiting |
| Wilmington, North Carolina, United States, 28402 | |
| Contact: Lynette Racco, OCN 910-343-4075 Lynette.Racco@nhrmc.org | |
| Contact: Monique Harris (910) 343-7641 Monique.Harris@nhrmc.org | |
| Principal Investigator: Walter Gajewski, MD, | |
| United States, Pennsylvania | |
| Geisinger Medical Center | Not yet recruiting |
| Danville, Pennsylvania, United States, 17822 | |
| Contact: Kristina Evans, MPH 570-214-9553 ksevans@geisinger.edu | |
| Contact: Eric Wagner eswagner@geisinger.edu | |
| Principal Investigator: John Nash, MD | |
| United States, Rhode Island | |
| Women & Infants Hospital Rhode Island | Recruiting |
| Providence, Rhode Island, United States, 02905 | |
| Contact: Wendy B Young, MSN, NP-C, OCN 401.270.6221 wyoung@wihri.org | |
| Contact: Janet Mari, RN, CCRC 401.274.1122 ext 2843 jmari@wihri.org | |
| Principal Investigator: Paul DiSilvestro, MD | |
| United States, Tennessee | |
| Adams Patterson Gynecology & Obstetrics | Recruiting |
| Memphis, Tennessee, United States, 38120 | |
| Contact: Jennifer Hamil, RN 901-507-1014 Jennifer.Hamil@scresearch.net | |
| Principal Investigator: Todd Chappell, MD | |
| Jackson Clinic | Recruiting |
| Jackson, Tennessee, United States, 38305 | |
| Contact: Dawn Coleman 731-660-8320 dawn.coleman@scresearch.net | |
| Principal Investigator: John J Ball, MD | |
| Principal Investigator: | Richard Moore, MD, FACOG, FACS | Women & Infants Hospital Rhode Island |
More Information
| Responsible Party: | Fujirebio Diagnostics, Inc. ( Rebecca Simamora, Director Clinical Affairs ) |
| Study ID Numbers: | FDI-15 |
| Study First Received: | September 30, 2009 |
| Last Updated: | November 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00987649 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
pelvic mass ovarian cancer adnexal mass CA125 HE4 |
|
Genital Diseases, Female Neoplasms Neoplasms by Site Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female |
Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Adnexal Diseases Endocrine Gland Neoplasms |
