Ovarian CancerCA125NCT02247323
Ovarian Malignancy Incidence in Moderate Risk Women With Low CA 125
An observational study of Ovarian Cancer, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The investigators are assessing the incidence of ovarian cancer in premenopausal women who were at moderate risk of malignancy with low CA125. Read more about this study
- Who is it for?
- Ages 45 to 50 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Risk of malignancy index
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Dec 2021
- 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 45 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Premenopausal who had complex ovarian mass with low CA125 and at moderate risk for malignancy by RMI.
Who may be able to join
- Women with complex ovarian cyst
- Abdominal pain
- Menometrorrhagia
Who cannot join
- Significant weight loss
- Cachexia
- History of ovarian or other malignancy
- Family history of ovarian Cancer
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Beni-Suef University
Cairo
Nesreen A Shehata, MD, 00201227866337, nesoomar@yahoo.com
Abdelgany M Hassan, MD, 00201017801604
About this study
Official title: Ovarian Malignancy Incidence in Premenopausal Women Who Were at Moderate Risk for Malignancy by Risk of Malignancy Index With Low CA 125.(Retrospective Study)
The investigators are assessing the incidence of ovarian cancer in premenopausal women who were at moderate risk of malignancy with low CA125.
Read the detailed description
About 10% of premenopausal women may have a surgery for ovarian masses. In premenopausal women the incidence of ovarian malignancy is 1:1000 in case of symptomatic ovarian cyst.1 CA125 is unreliable in differentiating benign from malignant ovarian mass in premenopausal women due to many false positive results and reduced specificity.1 pelvic vaginal ultrasonography is the most effective tool in evaluating ovarian masses due to increased sensitivity over abdominal US.1 An estimation of risk of malignancy index is essential in evaluating an ovarian mass.26 /2 Risk of malignancy index combines presurgical features serum including CA125, menopausal status and ultrasound findings. RMI=Ux Mx CA125 in which each feature takes a score and after calculation score less than 25 is mild, from 25-250 moderate and more than 250 has a severe risk of malignancy needing oncologist.44/3
- Conditions
- Ovarian Cancer
- Being tested
- Risk of malignancy index
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk of malignancy indexOther
Also called RMI
Calculation of RMI before sugery.
| Study group | Role | What they receive |
|---|---|---|
| premenopausal women | premenopausal women with complex ovarian mass moderate for malignancy by risk of malignancy index score and low CA125. Receives: Other: Risk of malignancy index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ovarian malignancy
Calculation of number of women who had ovarian cancer after an operation in moderate risk
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startJan 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University
- Investigators
- Nesreen A Shehata, MD, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247323
- Sponsor's protocol ID
- Beni-Suef 6
- Acronym
- CA125
- Status last verified
- Jan 2021
- First submitted
- 19 Sep 2014
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Malignancy Incidence in Premenopausal Women Who Were at Moderate Risk for Malignancy by Risk of Malignancy Index With Low CA 125.(Retrospective Study)
- ClinicalTrials.gov ID
- NCT02247323
- Acronym / sponsor ID
- CA125 / Beni-Suef 6
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 25 Sep 2014 (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 investigators are assessing the incidence of ovarian cancer in premenopausal women who were at moderate risk of malignancy with low CA125.
Detailed description
About 10% of premenopausal women may have a surgery for ovarian masses. In premenopausal women the incidence of ovarian malignancy is 1:1000 in case of symptomatic ovarian cyst.1 CA125 is unreliable in differentiating benign from malignant ovarian mass in premenopausal women due to many false positive results and reduced specificity.1 pelvic vaginal ultrasonography is the most effective tool in evaluating ovarian masses due to increased sensitivity over abdominal US.1 An estimation of risk of malignancy index is essential in evaluating an ovarian mass.26 /2 Risk of malignancy index combines presurgical features serum including CA125, menopausal status and ultrasound findings. RMI=Ux Mx CA125 in which each feature takes a score and after calculation score less than 25 is mild, from 25-250 moderate and more than 250 has a severe risk of malignancy needing oncologist.44/3
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| premenopausal women | – | Other: Risk of malignancy indexpremenopausal women with complex ovarian mass moderate for malignancy by risk of malignancy index score and low CA125. |
Who may qualify
- Ages
- 45 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Premenopausal who had complex ovarian mass with low CA125 and at moderate risk for malignancy by RMI.
Key inclusion criteria (3 listed)
- Women with complex ovarian cyst
- Abdominal pain
- Menometrorrhagia
Key exclusion criteria (4 listed)
- Significant weight loss
- Cachexia
- History of ovarian or other malignancy
- Family history of ovarian Cancer
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 |
|---|---|---|
| Risk of malignancy indexAlso: RMICalculation of RMI before sugery. | Other | premenopausal women |
Primary outcome
Incidence of ovarian malignancy
Time frame: one year
Calculation of number of women who had ovarian cancer after an operation in moderate risk
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- National Institute for health and clinical excellence. Ovarian cancer:The recognition and initial management of ovarian cancer.NICE clinical guideline 122.London:NICE;2011Link 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.
Nesreen A Shehata, MD principal investigator
Beni-Suef University
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 Cancer, run by Beni-Suef University at 1 site in Egypt.
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 3 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: status not confirmed, as of the sponsor's last update on 2 Feb 2021. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nesreen A Shehata, MD (00201227866337, nesoomar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ovarian malignancy (time frame: one year). 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 2 Feb 2021.