Ovarian CancerNCT00315692
Risk of Ovarian Cancer in Patients With a Pelvic Mass
An observational study of Ovarian Cancer, run by Fujirebio Diagnostics, Inc. at 2 sites in United States.
Trial summary
The purpose of this clinical trial is to evaluate the ability of multiple serum biomarkers to estimate the risk of ovarian cancer in women presenting with pelvic mass (defined as a simple, complex or a solid ovarian cyst / pelvic mass). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Biomarker Assay (CA125 and HE4)
- Type of treatment
- Medical device
- How many people
- 566 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2005to Feb 2007
- 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 undergoing surgery for the removal of a pelvic mass.
Who may be able to join
- Females selected to undergo laparotomy or laparoscopy based on a finding of pelvic mass (defined as a simple, complex or a solid ovarian cyst / pelvic mass);
- Pre- and post-menopausal women greater than or equal to 18 years of age;
- Pelvic mass must be demonstrated by ultrasound
- Able to understand and sign Informed Consent
Who cannot join
- Treatment for any malignancy (with the exception of non-melanoma skin cancer) within the last five years
- Subjects receiving cytotoxic chemotherapies, such as cyclophosphamide or methotrexate
- Subjects with previous bilateral oophorectomy
- Any subject known to be pregnant
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fujirebio Diagnostics, Inc
Malvern, Pennsylvania, 19355
Richard Moore
Providence, Rhode Island, 02905
About this study
Official title: Evaluation of a Multiple Biomarker Assay to Estimate the Risk of Ovarian Cancer in Patients Presenting With a Pelvic Mass.
The purpose of this clinical trial is to evaluate the ability of multiple serum biomarkers to estimate the risk of ovarian cancer in women presenting with pelvic mass (defined as a simple, complex or a solid ovarian cyst / pelvic mass).
Read the detailed description
The Pelvic Mass study is a prospective, multi-center, double blind, statistically powered clinical trial that will enroll female subjects ≥18 years of age presenting to a gynecologist or gynecological oncologist with a pelvic mass (defined as a simple, complex or a solid ovarian cyst / pelvic mass) who are scheduled to undergo surgery.
The serum tumor marker CA125 has been the most widely used marker in ovarian cancer, however, it is not sufficiently sensitive or specific for the detection of early stage disease. The levels of soluble mesothelin related peptides (SMRP) and HE4 have also recently been found to be elevated in women with ovarian cancer. The results of a pilot study suggest that the use of HE4 may improve the sensitivity of CA125 and provide for stratification of patients presenting with a pelvic mass into high, intermediate and low risk groups.
HE4 and CA125 serum levels will be evaluated in this study for their ability to stratify patients presenting with a pelvic mass into risk groups with low, intermediate or high probabilities of harboring an ovarian cancer at the time of initial presentation. The algorithm using these two serum markers to stratify patients that was developed using pilot study data will be evaluated in this prospective multicenter pelvic mass study. We will also evaluate the inclusion of additional biomarkers and risk factors, such as ultrasound score, age, and menopausal status, into the algorithm to see if there is any improvement in the stratification of patients into the risk groups.
The primary objective of the study is to estimate the risk of finding ovarian cancer at the time of surgery in pre- and post-menopausal women presenting with pelvic mass. Multiple serum biomarkers (CA125 and HE4) will be evaluated to estimate the risk that the patient is harboring an ovarian cancer at the time of presentation.
The secondary objective of the study is to develop a multivariate predictive algorithm combining CA125 and HE4 with radiological imaging results, and patient risk factors (such as age, menopausal status and ethnicity) to estimate the risk of ovarian cancer, including low malignant potential (LMP) / borderline tumors, at the time of surgery in patients presenting with a pelvic mass.
The exploratory endpoints will include the evaluation of serum, plasma and/or urine levels of CA125, HE4 and other additional novel biomarkers such as SMRP, alone and in combination with radiological imaging results and subject risk factors to determine their ability to estimate the risk of cancer at the time of surgery in patients presenting with a pelvic mass.
- Conditions
- Ovarian Cancer
- Being tested
- Biomarker Assay (CA125 and HE4)
- Keywords
- Ovarian Neoplasms
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker Assay (CA125 and HE4)Device
| Study group | Role | What they receive |
|---|---|---|
| Premenopausal women | Not described Receives: Device: Biomarker Assay (CA125 and HE4) | |
| Postmenopausal women | Not described Receives: Device: Biomarker Assay (CA125 and HE4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer vs Benign Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2006 (estimated)
- Study startDec 2005
- Study completionFeb 2007
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 Ovarian CancerStudies 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
- 566 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujirebio Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Moore, M.D., Principal investigator, Womens and Infant's Hosapital of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315692
- Sponsor's protocol ID
- FDI-03 Pelvic Mass Study
- Status last verified
- Nov 2011
- First submitted
- 18 Apr 2006
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Moore RG, McMeekin DS, Brown AK, DiSilvestro P, Miller MC, Allard WJ, Gajewski W, Kurman R, Bast RC Jr, Skates SJ. A novel multiple marker bioassay utilizing HE4 and CA125 for the prediction of ovarian cancer in patients with a pelvic mass. Gynecol Oncol. 2009 Jan;112(1):40-6. doi: 10.1016/j.ygyno.2008.08.031. Epub 2008 Oct 12.
PubMed 18851871
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Multiple Biomarker Assay to Estimate the Risk of Ovarian Cancer in Patients Presenting With a Pelvic Mass.
- ClinicalTrials.gov ID
- NCT00315692
- Acronym / sponsor ID
- FDI-03 Pelvic Mass Study
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 566 participants (actual)
- Lead sponsor
- Fujirebio Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2005
- Study completion
- Feb 2007 (actual)
- First posted
- 19 Apr 2006 (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 clinical trial is to evaluate the ability of multiple serum biomarkers to estimate the risk of ovarian cancer in women presenting with pelvic mass (defined as a simple, complex or a solid ovarian cyst / pelvic mass).
Detailed description
The Pelvic Mass study is a prospective, multi-center, double blind, statistically powered clinical trial that will enroll female subjects ≥18 years of age presenting to a gynecologist or gynecological oncologist with a pelvic mass (defined as a simple, complex or a solid ovarian cyst / pelvic mass) who are scheduled to undergo surgery.
The serum tumor marker CA125 has been the most widely used marker in ovarian cancer, however, it is not sufficiently sensitive or specific for the detection of early stage disease. The levels of soluble mesothelin related peptides (SMRP) and HE4 have also recently been found to be elevated in women with ovarian cancer. The results of a pilot study suggest that the use of HE4 may improve the sensitivity of CA125 and provide for stratification of patients presenting with a pelvic mass into high, intermediate and low risk groups.
HE4 and CA125 serum levels will be evaluated in this study for their ability to stratify patients presenting with a pelvic mass into risk groups with low, intermediate or high probabilities of harboring an ovarian cancer at the time of initial presentation. The algorithm using these two serum markers to stratify patients that was developed using pilot study data will be evaluated in this prospective multicenter pelvic mass study. We will also evaluate the inclusion of additional biomarkers and risk factors, such as ultrasound score, age, and menopausal status, into the algorithm to see if there is any improvement in the stratification of patients into the risk groups.
The primary objective of the study is to estimate the risk of finding ovarian cancer at the time of surgery in pre- and post-menopausal women presenting with pelvic mass. Multiple serum biomarkers (CA125 and HE4) will be evaluated to estimate the risk that the patient is harboring an ovarian cancer at the time of presentation.
The secondary objective of the study is to develop a multivariate predictive algorithm combining CA125 and HE4 with radiological imaging results, and patient risk factors (such as age, menopausal status and ethnicity) to estimate the risk of ovarian cancer, including low malignant potential (LMP) / borderline tumors, at the time of surgery in patients presenting with a pelvic mass.
The exploratory endpoints will include the evaluation of serum, plasma and/or urine levels of CA125, HE4 and other additional novel biomarkers such as SMRP, alone and in combination with radiological imaging results and subject risk factors to determine their ability to estimate the risk of cancer at the time of surgery in patients presenting with a pelvic mass.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premenopausal women | – | Device: Biomarker Assay (CA125 and HE4) |
| Postmenopausal women | – | Device: Biomarker Assay (CA125 and HE4) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing surgery for the removal of a pelvic mass.
Key inclusion criteria (4 listed)
- Females selected to undergo laparotomy or laparoscopy based on a finding of pelvic mass (defined as a simple, complex or a solid ovarian cyst / pelvic mass);
- Pre- and post-menopausal women greater than or equal to 18 years of age;
- Pelvic mass must be demonstrated by ultrasound
- Able to understand and sign Informed Consent
Key exclusion criteria (4 listed)
- Treatment for any malignancy (with the exception of non-melanoma skin cancer) within the last five years
- Subjects receiving cytotoxic chemotherapies, such as cyclophosphamide or methotrexate
- Subjects with previous bilateral oophorectomy
- Any subject known to be pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarker Assay (CA125 and HE4) | Device | Postmenopausal women, Premenopausal women |
Primary outcome
Cancer vs Benign Disease
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 8 Nov 2011.
- Derived from this study: PubMed 18851871Moore RG, McMeekin DS, Brown AK, DiSilvestro P, Miller MC, Allard WJ, Gajewski W, Kurman R, Bast RC Jr, Skates SJ. A novel multiple marker bioassay utilizing HE4 and CA125 for the prediction of ovarian cancer in patients with a pelvic mass. Gynecol Oncol. 2009 Jan;112(1):40-6. doi: 10.1016/j.ygyno.2008.08.031. Epub 2008 Oct 12.
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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, M.D. principal investigator
Womens and Infant's Hosapital of Rhode Island
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 Ovarian Cancer, 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 8 Nov 2011. 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?
Cancer vs Benign Disease. 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 NCT00315692, 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 8 Nov 2011.