Adnexal MassNCT00987649
Ovarian Cancer Risk Estimation in Patients With Pelvic Mass
An observational study of Adnexal Mass and Ovarian Cancer, run by Fujirebio Diagnostics, Inc. at 13 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adnexal Mass, Ovarian Cancer
- How many people
- 512 participants
- Where
- 13 sitesUnited States
- Study dates
- Oct 2009to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: It is anticipated that approximately 10 general or specialty centers geographically dispersed throughout the United States will be utilized.
Who may be able to join
- Female, age ≥ 18 years
- Adnexal mass present documented by imaging
- Scheduled to undergo surgery based on a finding of adnexal mass (defined as a simple, complex or a solid ovarian cyst/or any mass in pelvis)
- Able to understand and willing to provide Informed Consent
Who cannot join
- Previous history of ovarian cancer
- Previous history of bilateral oophorectomy
- Currently known to be pregnant
- Unable to provide informed consent
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Woman's Hospital
Baton Rouge, Louisiana, 70815
Chattanooga GYN-ONCOLOGY
Chattanooga, Tennessee, 37403
Geisinger Medical Center
Danville, Pennsylvania, 17822
Women's Clinic of Northern Colorado
Fort Collins, Colorado, 80524
Jackson Clinic
Jackson, Tennessee, 38305
OB/GYN Specialists of the Palm Beaches
Jupiter, Florida, 33458
Adams Patterson Gynecology & Obstetrics
Memphis, Tennessee, 38120
Weill Medical College of Cornell University
New York, New York, 10021
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73110
Women & Infants Hospital Rhode Island
Providence, Rhode Island, 02905
Scripps Clinic Carmel Valley
San Diego, California, 92130
University of South Florida Medical Center
Tampa, Florida, 33606
New Hanover Regional Medical Center
Wilmington, North Carolina, 28402
About this study
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
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.
- Conditions
- Adnexal Mass, Ovarian Cancer
- Keywords
- pelvic mass, ovarian cancer, adnexal mass, CA125, HE4
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
1. A statistically higher number of cancer patients are correctly assigned by the combination of Initial Cancer Risk assessment and positive ROMA test result than by Initial Cancer Risk assessment alone
Measured: Blood draw within 30 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adnexal MassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujirebio Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Advanced Clinical Research Services, LLC, ReSearch Pharmaceutical Services, Inc.
- Investigators
- Richard Moore, MD, FACOG, FACS, Principal investigator, Women & Infants Hospital Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987649
- Sponsor's protocol ID
- FDI-15
- Status last verified
- Feb 2011
- First submitted
- 30 Sep 2009
- Last updated
- 9 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Moore RG, Hawkins DM, Miller MC, Landrum LM, Gajewski W, Ball JJ, Allard WJ, Skates SJ. Combining clinical assessment and the Risk of Ovarian Malignancy Algorithm for the prediction of ovarian cancer. Gynecol Oncol. 2014 Dec;135(3):547-51. doi: 10.1016/j.ygyno.2014.10.017. Epub 2014 Oct 23.
PubMed 25449569
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00987649
- Acronym / sponsor ID
- FDI-15
- Conditions
- Adnexal Mass, Ovarian Cancer
- Keywords
- pelvic mass, ovarian cancer, adnexal mass, CA125, HE4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- Fujirebio Diagnostics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Advanced Clinical Research Services, LLC, ReSearch Pharmaceutical Services, Inc.
- Study start
- Oct 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 1 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is anticipated that approximately 10 general or specialty centers geographically dispersed throughout the United States will be utilized.
Key inclusion criteria (4 listed)
- Female, age ≥ 18 years
- Adnexal mass present documented by imaging
- Scheduled to undergo surgery based on a finding of adnexal mass (defined as a simple, complex or a solid ovarian cyst/or any mass in pelvis)
- Able to understand and willing to provide Informed Consent
Key exclusion criteria (4 listed)
- Previous history of ovarian cancer
- Previous history of bilateral oophorectomy
- Currently known to be pregnant
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1. A statistically higher number of cancer patients are correctly assigned by the combination of Initial Cancer Risk assessment and positive ROMA test result than by Initial Cancer Risk assessment alone
Time frame: Blood draw within 30 days of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2011.
- Derived from this study: PubMed 25449569Moore RG, Hawkins DM, Miller MC, Landrum LM, Gajewski W, Ball JJ, Allard WJ, Skates SJ. Combining clinical assessment and the Risk of Ovarian Malignancy Algorithm for the prediction of ovarian cancer. Gynecol Oncol. 2014 Dec;135(3):547-51. doi: 10.1016/j.ygyno.2014.10.017. Epub 2014 Oct 23.
- Information related to Fujirebio Diagnostics, Inc.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Moore, MD, FACOG, FACS principal investigator
Women & Infants Hospital Rhode Island
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adnexal Mass and Ovarian Cancer, run by Fujirebio Diagnostics, Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. A statistically higher number of cancer patients are correctly assigned by the combination of Initial Cancer Risk assessment and positive ROMA test result than by Initial Cancer Risk assessment alone (time frame: Blood draw within 30 days of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00987649, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2011.