Adnexal MassNCT01466049
New Biomarkers Evaluating Ovarian Cancer
An observational study of Adnexal Mass, run by Fujirebio Diagnostics, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate new biomarkers for patients presenting to a physician for surgery to remove a mass in their pelvis and to continue to evaluate these types of patients using the ROMA algorithm for post-market benefits. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adnexal Mass
- How many people
- 280 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2011to Mar 2014
- 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: Women with an adnexal mass, presenting to a general surgeon or obstetrician/ gynecologist at a general or specialty center within the United States, for whom a decision to proceed with surgery to remove the mass has been made.
Who may be able to join
- Female, age 18 years or older
- Adnexal mass present documented by imaging
- Scheduled to undergo surgery based on a finding of adnexal mass
- Able 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
2 sites in 1 country.
United States2 sites
University of Oklahoma
Oklahoma City, Oklahoma, 73110
New Hanover Regional Medical Center
Wilmington, North Carolina, 28402
About this study
Official title: Evaluation of New Biomarker Assays in Ovarian Cancer Patients Presenting to a Generalist With an Adnexal Mass
The purpose of this study is to evaluate new biomarkers for patients presenting to a physician for surgery to remove a mass in their pelvis and to continue to evaluate these types of patients using the ROMA algorithm for post-market benefits.
- Conditions
- Adnexal Mass
- Keywords
- Ovarian Cancer, Adnexal Mass, Pelvic Mass
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate novel biomarkers for patients with an adnexal mass
Measured: observational studies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujirebio Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diana Dickson, Study director, Fujirebio Diagnostics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466049
- Sponsor's protocol ID
- FDI-35
- Status last verified
- Aug 2014
- First submitted
- 3 Nov 2011
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of New Biomarker Assays in Ovarian Cancer Patients Presenting to a Generalist With an Adnexal Mass
- ClinicalTrials.gov ID
- NCT01466049
- Acronym / sponsor ID
- FDI-35
- Conditions
- Adnexal Mass
- Keywords
- Ovarian Cancer, Adnexal Mass, Pelvic Mass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Fujirebio Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 7 Nov 2011 (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 evaluate new biomarkers for patients presenting to a physician for surgery to remove a mass in their pelvis and to continue to evaluate these types of patients using the ROMA algorithm for post-market benefits.
Study design
- Observational model
- Cohort
- 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
- Women with an adnexal mass, presenting to a general surgeon or obstetrician/ gynecologist at a general or specialty center within the United States, for whom a decision to proceed with surgery to remove the mass has been made.
Key inclusion criteria (4 listed)
- Female, age 18 years or older
- Adnexal mass present documented by imaging
- Scheduled to undergo surgery based on a finding of adnexal mass
- Able 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
Evaluate novel biomarkers for patients with an adnexal mass
Time frame: observational studies
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 5 Aug 2014.
Related trials for Adnexal Mass
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Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
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Recruiting
MIRRORS-FROZEN - Comparing Open Vs Robotic Surgery in the Management of Women With Complex Pelvic Adnexal Masses ≤ 8cm.
Ovarian Cancer, Ovarian Mass
Active, not recruitingObservational study
A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women With an Ovarian Mass
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AI Analysis of CT Scans to Classify Ovarian Tumours as Benign, Borderline or Malignant Before Surgery
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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.
Diana Dickson study director
Fujirebio Diagnostics, Inc.
2 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, run by Fujirebio Diagnostics, Inc. at 2 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 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Evaluate novel biomarkers for patients with an adnexal mass (time frame: observational studies). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2014.