Ovarian NeoplasmsIOTA-CA125NCT06977334
IOTA Ultrasound Criteria and Serum CA 125 for Ovarian Malignancy Detection
An observational study of Ovarian Neoplasms and Ovarian Cancer, run by Maharajgunj Medical Campus at 1 site in Nepal.
Trial summary
This cross-sectional analytic study assessed the diagnostic accuracy of IOTA Simple Rules versus serum CA 125 in women with adnexal masses undergoing surgery. Eighty-two percent of tumors were classifiable by IOTA criteria; CA 125 cut-offs of 35, 70, and 105 U/mL were evaluated against histopathology gold standard. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms, Ovarian Cancer, Ovarian Carcinoma
- How many people
- 64 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jan 2022to 31 Dec 2022
- 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
- Adult, Older adult
Study population: The patient assigned for surgery due to an ovarian tumor in the Department of Obstetrics and Gynecology, Nobel Medical College Teaching Hospital (NOMCTH), Kanchanbari 5, Biratnagar
Who may be able to join
- All age groups and parity with ovarian mass admitted for scheduled surgery.
Who cannot join
- Proven cases of ovarian malignancy
- Ovarian mass in pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Ovarian Malignancy With Ultrasonography Based Criteria (IOTA) and Serum CA 125
This cross-sectional analytic study assessed the diagnostic accuracy of IOTA Simple Rules versus serum CA 125 in women with adnexal masses undergoing surgery. Eighty-two percent of tumors were classifiable by IOTA criteria; CA 125 cut-offs of 35, 70, and 105 U/mL were evaluated against histopathology gold standard.
Read the detailed description
All women admitted to the Department of Obstetrics and Gynecology and assigned for the surgery of adnexal mass were enrolled in the study. After written informed consent, the clinical proforma was filled up. Data collection regarding age, current or previous hormonal contraception, menopausal status and family history of breast or ovarian cancer, clinical presentation. Participants were scheduled for ultrasound evaluation done according to IOTA simple rules (five malignant features and five benign features) and peripheral blood was collected for tumor marker serum CA125 measurement.
During ultrasonographic examination, the morphology of the adnexal masses was characterized using 2D real-time and color Doppler ultrasound. Adnexal masses were described according to origin (ovarian/extra ovarian); position (right/left/bilateral); number of lesions; type of lesions (unilocular/unilocular - solid/multilocular/multilocular - solid); size; volume; intracystic fluid echogenicity; number of locations; presence and size of septations; presence, number, size of solid papillary projections; largest solid component; presence / absent of ascites. These parameters are used as designation according to IOTA Group.
For the sample of CA125, approximately 2 ml blood was collected and registered patient's hospital number, then the selected reagent was added to the sample and kept in a fully automated immunoassay system in the hospital laboratory where electrochemiluminescence Immunoassay method (ECLIA) is used for the analysis. Surgery was performed in the hospital and a biopsy was sent for the histopathology examination in the same hospital.
Sensitivity, specificity, positive predictive value, and negative predictive values of CA125 and IOTA class were calculated. The correlation between CA 125 and IOTA simple rules was analyzed and compared with histopathological reports using the Pearson correlation method. The area under the receiver operating characteristic curve (AUC) was used to determine the point at which CA125 had the highest sensitivity and specificity in distinguishing histologically malignant from benign tumors.
- Conditions
- Ovarian Neoplasms, Ovarian Cancer, Ovarian Carcinoma
- Keywords
- IOTA, CA 125, Ultrasonography, Ovarian malignancy
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of IOTA Simple Rules
Proportion of histologically malignant masses correctly identified by IOTA criteria.
Measured: At surgery/histopathology
Specificity of IOTA Simple Rules
Proportion of histologically malignant masses correctly identified by IOTA criteria.
Measured: At surgery/histopathology
Sensitivity of Serum CA 125 (cut-off 35 U/mL)
Proportion of malignant tumors with CA 125 >35 U/mL.
Measured: Preoperative blood draw
Specificity of Serum CA 125 (cut-off 35 U/mL)
Proportion of benign tumors with CA 125 ≤35 U/mL.
Measured: Preoperative blood draw
Area Under the ROC Curve for CA 125
Discriminatory performance of CA 125 at multiple cut-off points.
Measured: Preoperative blood draw vs histopathology
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharajgunj Medical Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Yadav, Maharajgunj Medical Campus
- Investigators
- Chandrika Dangol, MD, Study director, Nobel Medical College Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977334
- Sponsor's protocol ID
- IRC-NMCTH-08/2021
- Acronym
- IOTA-CA125
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 18 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Ovarian Malignancy With Ultrasonography Based Criteria (IOTA) and Serum CA 125
- ClinicalTrials.gov ID
- NCT06977334
- Acronym / sponsor ID
- IOTA-CA125 / IRC-NMCTH-08/2021
- Conditions
- Ovarian Neoplasms, Ovarian Cancer, Ovarian Carcinoma
- Keywords
- IOTA, CA 125, Ultrasonography, Ovarian malignancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Maharajgunj Medical CampusUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 18 May 2025 (actual)
- 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.
This cross-sectional analytic study assessed the diagnostic accuracy of IOTA Simple Rules versus serum CA 125 in women with adnexal masses undergoing surgery. Eighty-two percent of tumors were classifiable by IOTA criteria; CA 125 cut-offs of 35, 70, and 105 U/mL were evaluated against histopathology gold standard.
Detailed description
All women admitted to the Department of Obstetrics and Gynecology and assigned for the surgery of adnexal mass were enrolled in the study. After written informed consent, the clinical proforma was filled up. Data collection regarding age, current or previous hormonal contraception, menopausal status and family history of breast or ovarian cancer, clinical presentation. Participants were scheduled for ultrasound evaluation done according to IOTA simple rules (five malignant features and five benign features) and peripheral blood was collected for tumor marker serum CA125 measurement.
During ultrasonographic examination, the morphology of the adnexal masses was characterized using 2D real-time and color Doppler ultrasound. Adnexal masses were described according to origin (ovarian/extra ovarian); position (right/left/bilateral); number of lesions; type of lesions (unilocular/unilocular - solid/multilocular/multilocular - solid); size; volume; intracystic fluid echogenicity; number of locations; presence and size of septations; presence, number, size of solid papillary projections; largest solid component; presence / absent of ascites. These parameters are used as designation according to IOTA Group.
For the sample of CA125, approximately 2 ml blood was collected and registered patient's hospital number, then the selected reagent was added to the sample and kept in a fully automated immunoassay system in the hospital laboratory where electrochemiluminescence Immunoassay method (ECLIA) is used for the analysis. Surgery was performed in the hospital and a biopsy was sent for the histopathology examination in the same hospital.
Sensitivity, specificity, positive predictive value, and negative predictive values of CA125 and IOTA class were calculated. The correlation between CA 125 and IOTA simple rules was analyzed and compared with histopathological reports using the Pearson correlation method. The area under the receiver operating characteristic curve (AUC) was used to determine the point at which CA125 had the highest sensitivity and specificity in distinguishing histologically malignant from benign tumors.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- The patient assigned for surgery due to an ovarian tumor in the Department of Obstetrics and Gynecology, Nobel Medical College Teaching Hospital (NOMCTH), Kanchanbari 5, Biratnagar
Key inclusion criteria (1 listed)
- All age groups and parity with ovarian mass admitted for scheduled surgery.
Key exclusion criteria (2 listed)
- Proven cases of ovarian malignancy
- Ovarian mass in pregnancy
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
Sensitivity of IOTA Simple Rules
Time frame: At surgery/histopathology
Proportion of histologically malignant masses correctly identified by IOTA criteria.
Specificity of IOTA Simple Rules
Time frame: At surgery/histopathology
Proportion of histologically malignant masses correctly identified by IOTA criteria.
Sensitivity of Serum CA 125 (cut-off 35 U/mL)
Time frame: Preoperative blood draw
Proportion of malignant tumors with CA 125 >35 U/mL.
Specificity of Serum CA 125 (cut-off 35 U/mL)
Time frame: Preoperative blood draw
Proportion of benign tumors with CA 125 ≤35 U/mL.
Area Under the ROC Curve for CA 125
Time frame: Preoperative blood draw vs histopathology
Discriminatory performance of CA 125 at multiple cut-off points.
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 18 May 2025.
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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.
Chandrika Dangol, MD study director
Nobel Medical College Teaching Hospital
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 Neoplasms and Ovarian Cancer, run by Maharajgunj Medical Campus at 1 site in Nepal.
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: finished, as of the sponsor's last update on 18 May 2025. 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 Nepal. 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?
Sensitivity of IOTA Simple Rules (time frame: At surgery/histopathology). The study lists 5 primary outcomes in all. 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 May 2025.