Ovarian CancerNCT06851429
Ovarian Cancer Identification on CT Using Deep Learning
An observational study of Ovarian Cancer, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
Trial summary
Ovarian cancer remains the deadliest gynecologic malignancy, with poor survival rates largely due to late-stage diagnosis. Early detection is crucial, yet no universally accepted screening method exists. Current imaging techniques and biomarkers, such as CA-125, have limitations in specificity and sensitivity. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer
- How many people
- 12,578 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Sep 2022to 31 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who have undergone a CT scan.
Who may be able to join
- Age ≥ 20 years old.
- Female
- undergone a CT scan
- undergone a CT scan within 180 days prior to ovarian surgery for histopathological evaluation.
Who cannot join
- Age < 20 years old.
- Non-female
- Non-CT imaging
- Incorrect image orientation
- Number of slices < 10
- Slice thickness >10 mm or < 1 mm
Show all 11Show fewer
- Unsuccessful DICM-to-NIfTI
- Pelvic subvolume extraction failed
- Non-contrast CT scans
- Metallic artifacts
- Inconclusive cases
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 1 recruiting
- Recruiting
Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital
Taoyuan, Guishan, 333
Gigin Lin, MD, PhD, 886-3281200 ext. 2575, giginlin@cgmh.org.tw
Gigin Lin, MD, PhD
- Completed
Chang Gung Memorial Hospital
Taoyuan City, Guishan District, 333
About this study
Official title: Development and Validation of a Deep Learning Model for Ovarian Cancer Identification on CT: A Nationwide Population-Based and International Study
Ovarian cancer remains the deadliest gynecologic malignancy, with poor survival rates largely due to late-stage diagnosis. Early detection is crucial, yet no universally accepted screening method exists. Current imaging techniques and biomarkers, such as CA-125, have limitations in specificity and sensitivity. This study aims to develop and evaluate a deep learning-based computer-aided diagnosis tool (CAT-OV), for ovarian cancer detection using CT imaging. The system integrates a Body Part Regression (BPR) model for pelvic localization and a Multiple Instance Learning (MIL) ensemble classifier for cancer prediction. The model was trained and validated using retrospective datasets from Taiwan, the United States, and a nationwide real-world cohort. Stringent preprocessing and quality control measures were implemented to enhance model accuracy. Results highlight the potential of AI-driven CT screening in improving early detection, though further validation is needed for clinical adoption.
Read the detailed description
Ovarian cancer is the deadliest gynecologic malignancy, with 20,890 new cases and 12,730 deaths expected in the U.S. in 2025. Despite accounting for only 2.1% of female cancers, it causes 4.3% of cancer-related deaths. The lifetime risk of developing ovarian cancer is 1 in 78, with a mortality risk of 1 in 108. Optimal treatment involves complete surgical resection followed by chemotherapy; however, survival rates have remained largely unchanged over the past two decades. Early detection significantly improves survival, but only 31% of cases are diagnosed at an early stage due to the disease's asymptomatic nature. No universal screening test exists, and current methods, including CA-125 and transvaginal ultrasound, have limitations in reducing mortality.
Computed tomography (CT) is commonly used for ovarian cancer detection, but its effectiveness is limited by nonspecific symptoms. AI-driven CT screening has gained interest, with deep learning showing promise in cancer detection. However, challenges remain in ensuring model generalizability and optimizing technical parameters. Effective screening must minimize unnecessary surgeries, as previous trials reported high false-positive rates and surgical complications. To address this, the study developed CAT-OV, an AI-based tool for ovarian cancer detection using CT imaging. The system integrates a Body Part Regression (BPR) model for pelvic localization and a Multiple Instance Learning (MIL) ensemble classifier with five convolutional neural networks (CNNs) to predict cancer presence. CAT-OV was evaluated on three test sets: an internal dataset, an international dataset from the U.S., and a nationwide multi-institutional dataset from Taiwan.
This retrospective study was approved by the institutional review board, and informed consent was waived. The dataset was constructed from CT scans of patients aged ≥20 who underwent ovarian surgery between 2010 and 2020 at Chang Gung Memorial Hospital. Malignant cases included various histopathological subtypes, while controls consisted of benign ovarian tumors and an enriched dataset of cancer-free individuals. The final dataset comprised 5,680 cases, split into a training/validation set (n=4,554) and an internal test set (n=1,126), including 173 cancer and 953 control cases. The international dataset included 40 cancer and 47 control cases from Brigham and Women's Hospital. The nationwide dataset consisted of 447 ovarian cancer cases and 1,131 controls from Taiwan's National Health Insurance database.
The BPR model, modified from ResNet50, localized pelvic regions on CT scans through unsupervised learning. Training involved preprocessing, augmentation, and regression-based subvolume selection. The MIL classification model treated each 3D subvolume as a "bag" of 2D slices, using EfficientNetV2-S as the backbone and an attention-based aggregation module for final prediction. Training involved preprocessing, augmentation, and a five-fold cross-validation strategy. The final ensemble model determined classification based on averaged logits and optimized thresholds. Visualization was performed using the Per-Sample Bottleneck technique to enhance interpretability.
Surgical histopathology served as the reference standard, reviewed by an experienced pathologist using the 2020 WHO classification. Immunohistochemical analysis was conducted to distinguish primary ovarian cancer from metastases. Tumors were staged according to the 8th edition FIGO system. This study aims to improve ovarian cancer detection and screening efficacy through AI-driven CT analysis.
- Conditions
- Ovarian Cancer
- 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 |
|---|---|---|
| control group | The control group included both benign ovarian tumors and an enriched dataset. | |
| case group | ovarian cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of a deep learning-based computer-aided diagnosis tool (CAT-OV) for identification of primary ovarian cancer on CT
Sensitivity, Specificity, Accuracy, PPV, NPV, AUC
Measured: Perioperative/Periprocedural 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Sep 2022
- Primary completion7 Feb 2025
- Study completion31 Aug 2028 (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.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 12,578 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gigin Lin, Chang Gung Memorial Hospital
- Investigators
- Gigin Lin, MD, PhD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851429
- Sponsor's protocol ID
- 202201271B0
- Status last verified
- Aug 2026
- First submitted
- 24 Feb 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Deep Learning Model for Ovarian Cancer Identification on CT: A Nationwide Population-Based and International Study
- ClinicalTrials.gov ID
- NCT06851429
- Acronym / sponsor ID
- 202201271B0
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12,578 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 28 Feb 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.
Ovarian cancer remains the deadliest gynecologic malignancy, with poor survival rates largely due to late-stage diagnosis. Early detection is crucial, yet no universally accepted screening method exists. Current imaging techniques and biomarkers, such as CA-125, have limitations in specificity and sensitivity. This study aims to develop and evaluate a deep learning-based computer-aided diagnosis tool (CAT-OV), for ovarian cancer detection using CT imaging. The system integrates a Body Part Regression (BPR) model for pelvic localization and a Multiple Instance Learning (MIL) ensemble classifier for cancer prediction. The model was trained and validated using retrospective datasets from Taiwan, the United States, and a nationwide real-world cohort. Stringent preprocessing and quality control measures were implemented to enhance model accuracy. Results highlight the potential of AI-driven CT screening in improving early detection, though further validation is needed for clinical adoption.
Detailed description
Ovarian cancer is the deadliest gynecologic malignancy, with 20,890 new cases and 12,730 deaths expected in the U.S. in 2025. Despite accounting for only 2.1% of female cancers, it causes 4.3% of cancer-related deaths. The lifetime risk of developing ovarian cancer is 1 in 78, with a mortality risk of 1 in 108. Optimal treatment involves complete surgical resection followed by chemotherapy; however, survival rates have remained largely unchanged over the past two decades. Early detection significantly improves survival, but only 31% of cases are diagnosed at an early stage due to the disease's asymptomatic nature. No universal screening test exists, and current methods, including CA-125 and transvaginal ultrasound, have limitations in reducing mortality.
Computed tomography (CT) is commonly used for ovarian cancer detection, but its effectiveness is limited by nonspecific symptoms. AI-driven CT screening has gained interest, with deep learning showing promise in cancer detection. However, challenges remain in ensuring model generalizability and optimizing technical parameters. Effective screening must minimize unnecessary surgeries, as previous trials reported high false-positive rates and surgical complications. To address this, the study developed CAT-OV, an AI-based tool for ovarian cancer detection using CT imaging. The system integrates a Body Part Regression (BPR) model for pelvic localization and a Multiple Instance Learning (MIL) ensemble classifier with five convolutional neural networks (CNNs) to predict cancer presence. CAT-OV was evaluated on three test sets: an internal dataset, an international dataset from the U.S., and a nationwide multi-institutional dataset from Taiwan.
This retrospective study was approved by the institutional review board, and informed consent was waived. The dataset was constructed from CT scans of patients aged ≥20 who underwent ovarian surgery between 2010 and 2020 at Chang Gung Memorial Hospital. Malignant cases included various histopathological subtypes, while controls consisted of benign ovarian tumors and an enriched dataset of cancer-free individuals. The final dataset comprised 5,680 cases, split into a training/validation set (n=4,554) and an internal test set (n=1,126), including 173 cancer and 953 control cases. The international dataset included 40 cancer and 47 control cases from Brigham and Women's Hospital. The nationwide dataset consisted of 447 ovarian cancer cases and 1,131 controls from Taiwan's National Health Insurance database.
The BPR model, modified from ResNet50, localized pelvic regions on CT scans through unsupervised learning. Training involved preprocessing, augmentation, and regression-based subvolume selection. The MIL classification model treated each 3D subvolume as a "bag" of 2D slices, using EfficientNetV2-S as the backbone and an attention-based aggregation module for final prediction. Training involved preprocessing, augmentation, and a five-fold cross-validation strategy. The final ensemble model determined classification based on averaged logits and optimized thresholds. Visualization was performed using the Per-Sample Bottleneck technique to enhance interpretability.
Surgical histopathology served as the reference standard, reviewed by an experienced pathologist using the 2020 WHO classification. Immunohistochemical analysis was conducted to distinguish primary ovarian cancer from metastases. Tumors were staged according to the 8th edition FIGO system. This study aims to improve ovarian cancer detection and screening efficacy through AI-driven CT analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | –The control group included both benign ovarian tumors and an enriched dataset. |
| case group | – | –ovarian cancer |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who have undergone a CT scan.
Key inclusion criteria (4 listed)
- Age ≥ 20 years old.
- Female
- undergone a CT scan
- undergone a CT scan within 180 days prior to ovarian surgery for histopathological evaluation.
Key exclusion criteria (11 listed)
- Age < 20 years old.
- Non-female
- Non-CT imaging
- Incorrect image orientation
- Number of slices < 10
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
Performance of a deep learning-based computer-aided diagnosis tool (CAT-OV) for identification of primary ovarian cancer on CT
Time frame: Perioperative/Periprocedural 180 days
Sensitivity, Specificity, Accuracy, PPV, NPV, AUC
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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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.
Gigin Lin, MD, PhD principal investigator
Chang Gung Memorial Hospital
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 Chang Gung Memorial Hospital at 2 sites in Taiwan.
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 11 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gigin Lin, MD, PhD (886-3-3281200 ext. 2575, giginlin@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of a deep learning-based computer-aided diagnosis tool (CAT-OV) for identification of primary ovarian cancer on CT (time frame: Perioperative/Periprocedural 180 days). 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 12 Aug 2026.