Ovarian NeoplasmNCT01477788
Prediction of Ovarian Malignancy in the Presence of Sonographic Pelvic Mass
An observational study of Ovarian Neoplasm, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
The objective of the study is to create a test that will discriminate between malignant and benign ovarian mass that was diagnosed by ultrasound. The investigators will examine about 800 women and at the end of the study the investigators will combine data from the woman's history, the sonographic characters of the… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Neoplasm
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- May 2011to May 2011
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients referred to the department's sonographic unit with diagnosis of adnexal or pelvic or ovarian mass
Who may be able to join
- Patients referred with sonographic diagnosis of pelvic mass
Who cannot join
- Pregnant women
- Known gynecologic malignancy
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sonographic unit, Department of Ob/Gyn, Haemek medical center
Afula
About this study
Official title: Prediction of Ovarian Malignancy, in the Presence of Sonographic Pelvic Mass Using Patient History, Sonographic Parameters and Serum Markers
The objective of the study is to create a test that will discriminate between malignant and benign ovarian mass that was diagnosed by ultrasound. The investigators will examine about 800 women and at the end of the study the investigators will combine data from the woman's history, the sonographic characters of the mass and serum biological markers along with the woman's outcome (which means - whether the mass was malignant, benign, or disappeared or remained constant with no intervention).
Read the detailed description
Patients that arrive to the sonographic unit of the gynecological department with a diagnosis of ovarian mass will have a sonographic examination that include: Trans-vaginal +- trans-abdominal ultrasound with Doppler and three dimensional sonographic exam. anamnestic data will be collected and serum test for CA 125, HE4 and CEA. The management of the specific patient will be according to the department protocol, regardless the study data. The investigators will collect data about operation outcome and histological results of women that will be operated. Women that won't be operated on will be followed up every 6 months by the study team.
At the end of the study a statistical analysis will be made to create a sensitive and specific test for the prediction of malignancy in sonographic diagnosed ovarian mass.
- Conditions
- Ovarian Neoplasm
- Keywords
- pelvic mass, ovarian mass, ultrasound, serum markers, ovarian malignancy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| women, sonographic ovarian mass | women that will arrive to the sonographic unit of the gynecological department with the sonographic diagnosis of ovarian mass |
What is being measured
The primary outcome is the main question the study is designed to answer.
The risk of malignancy in the presence of pelvic mass demonstrated by sonography.
Using a combination of the results of US examination, patient's history and serum markers to predict the risk of malignancy in women with pelvic mass demonstrated by sonography.
Measured: Up to 2 months after recruiting and examining the last participant of the study
Secondary outcomes (3)
number and kind of operative complications
Information about operative complications will be collected from the files of participants who were operated
Measured: within one month after operation
Reasons for intervention
The reasons that led the treating physician to choose a surgical treatment will be collected from the files of the participants who were operated
Measured: within one month after operation
operative finding and histologic results
The operative finding and histologic results will be collected from the files of the participants who were operated
Measured: within one month after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: The researcher Left the organization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmStudies 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- Women and Infants Hospital of Rhode Island
- Responsible party
- Sponsor
- Investigators
- yfat kadan, MD, Principal investigator, Department of Ob/Gyn, Haemek medical center, Afula Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477788
- Sponsor's protocol ID
- EMC-0083-09
- Status last verified
- Nov 2011
- First submitted
- 13 Nov 2011
- Last updated
- 18 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Ovarian Malignancy, in the Presence of Sonographic Pelvic Mass Using Patient History, Sonographic Parameters and Serum Markers
- ClinicalTrials.gov ID
- NCT01477788
- Acronym / sponsor ID
- EMC-0083-09
- Conditions
- Ovarian Neoplasm
- Keywords
- pelvic mass, ovarian mass, ultrasound, serum markers, ovarian malignancy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The researcher Left the organization
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Collaborators
- Women and Infants Hospital of Rhode Island
- Study start
- May 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 23 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 objective of the study is to create a test that will discriminate between malignant and benign ovarian mass that was diagnosed by ultrasound. The investigators will examine about 800 women and at the end of the study the investigators will combine data from the woman's history, the sonographic characters of the mass and serum biological markers along with the woman's outcome (which means - whether the mass was malignant, benign, or disappeared or remained constant with no intervention).
Detailed description
Patients that arrive to the sonographic unit of the gynecological department with a diagnosis of ovarian mass will have a sonographic examination that include: Trans-vaginal +- trans-abdominal ultrasound with Doppler and three dimensional sonographic exam. anamnestic data will be collected and serum test for CA 125, HE4 and CEA. The management of the specific patient will be according to the department protocol, regardless the study data. The investigators will collect data about operation outcome and histological results of women that will be operated. Women that won't be operated on will be followed up every 6 months by the study team.
At the end of the study a statistical analysis will be made to create a sensitive and specific test for the prediction of malignancy in sonographic diagnosed ovarian mass.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women, sonographic ovarian mass | – | –women that will arrive to the sonographic unit of the gynecological department with the sonographic diagnosis of ovarian mass |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients referred to the department's sonographic unit with diagnosis of adnexal or pelvic or ovarian mass
Key inclusion criteria (1 listed)
- Patients referred with sonographic diagnosis of pelvic mass
Key exclusion criteria (2 listed)
- Pregnant women
- Known gynecologic malignancy
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
The risk of malignancy in the presence of pelvic mass demonstrated by sonography.
Time frame: Up to 2 months after recruiting and examining the last participant of the study
Using a combination of the results of US examination, patient's history and serum markers to predict the risk of malignancy in women with pelvic mass demonstrated by sonography.
3 secondary outcomes
number and kind of operative complications
Time frame: within one month after operation
Reasons for intervention
Time frame: within one month after operation
operative finding and histologic results
Time frame: within one month after operation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2015.
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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.
yfat kadan, MD principal investigator
Department of Ob/Gyn, Haemek medical center, Afula Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Neoplasm, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 18 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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 was withdrawn before enrolling participants, so there are no results.
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?
The risk of malignancy in the presence of pelvic mass demonstrated by sonography. (time frame: Up to 2 months after recruiting and examining the last participant of the study). 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 18 Jun 2015.