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Assessment of Ovarian Cysts Using Machine Learning

Prediction of Malignant Potential of Ovarian Cysts Using Machine Learning Models

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05342298
Acronym
OCID
Enrollment
1000
Registered
2022-04-22
Start date
2022-10-01
Completion date
2023-09-01
Last updated
2022-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cyst

Keywords

machine learning, ovarian masses, ovarian cystectomy

Brief summary

The study aims at creating a prediction model using machine learning algorithms that is capable of predicting malignant potential of ovarian cysts/masses based on patient characteristics, sonographic findings, and biochemical markers

Detailed description

Ovarian cysts are one of the most common gynecologic disorders encountered in clinical practice. Approximately 20% of women may experience ovarian cysts at least once in their lifetime. However, incidence of significant ovarian cysts is 8% in premenopausal. In fact, many ovarian cysts are discovered incidentally while pelvic imaging is done for other indications. Interestingly, prevalence of ovarian cysts may reach up to 14-18% in menopausal women, many of which are likely persistent (2). Although most ovarian cysts are benign, definitive diagnosis cannot be made based on one time sonographic findings. Simple cysts are typically benign. Complex and solid cysts are still likely benign. However, malignancy is more common in this group of cysts. Definitive diagnosis by histopathology warrants surgical removal of the cyst/ovary. Because the condition is common and is mostly benign, surgery is not considered unless malignancy is reasonably a concern or the cyst is symptomatic. Therefore, most ovarian cysts are expectantly managed. Aim of expectant management is to determine cyst changes. Follow-up may extend beyond a year. However, recommendations have not been consistent among internationally recognized guidelines, and different cut-offs of cyst size and different frequencies and durations of follow-up were considered (5, 6). Similarly, there are different systems that are adopted by these guidelines to triage women with ovarian cysts based on sonographic and biochemical indicators. This project aims at creating a prediction model using machine learning algorithms that can be applied to women with ovarian cysts. The aim of this mode is to determine probability of cancer and management plan including surgery, long-term or short-term follow-up. Retrieved records will be reviewed for eligibility. Patients will be considered for inclusion if they are postmenarchal, have documented follow-up for at least 1 year following initial presentation unless surgically managed, and provide authorization to use their medical records for research purposes. They should have received their care in the receptive centers. Women will be excluded from the study if they were admitted for an acute event including cyst torsion, rupture or hemorrhage with no prior documentation of ovarian cysts. Women with cysts smaller than 3 cm will not be eligible. A standardized data collection spreadsheet is designed for the purpose of the study and will be shared with all contributing centers. Data collection will include patient demographics (e.g., age, parity, body mass index, ethnicity, smoking status), gynecologic history (e.g., menstrual abnormalities, contraceptive status), medical history (e.g., including chronic health issues and personal history of cancers), surgical history, family history of cancers including any diagnosed familial cancer syndromes. Specific information on current presentation will comprise presenting symptoms, if any, relevant physical signs, sonographic features (e.g., cyst size, side, consistency, locularity, presence of septa, solid areas, papillae, intracystic fluid texture, associated pelvic fluid or ascites), features noted in other imaging modalities if any, tumor markers (CA125, HCG, ALP, LDH,HE-4), management plan including surgical findings and histopathological diagnosis, follow-up including follow-up findings and cyst/mass complications during follow-up.

Interventions

OTHERprediction model

Data will be pre-processed prior to final analysis, including data cleaning, imputation of missing values, dimensionality reduction, and removal of outliers. Data will be utilized as Xi and Yi where Xi presents input (features) and Yi presents dependent variables (outcomes). Different classification algorithms will be tested for accuracy to build the final model including logistic regression, SVM, XGboost and random forest algorithms. Data will be split at 0.8:0.2 for model training and testing, respectively.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

Females who are postmenarchal, have documented follow-up for at least 1 year following initial presentation unless surgically managed, and provide authorization to use their medical records for research purposes. They should have received their care in the receptive centers

Exclusion criteria

Women will be excluded from the study if they were admitted for an acute event including cyst torsion, rupture or hemorrhage with no prior documentation of ovarian cysts. Women with cysts smaller than 3 cm will not be eligible.

Design outcomes

Primary

MeasureTime frameDescription
Final diagnosis of ovarian cyst typeWithin 3 years of diagnosis of ovarian cystDiagnosis of whether the cyst is benign or malignant based on histopathology, or cyst resolution or shrinkage on follow-up

Secondary

MeasureTime frameDescription
Incidence of acute events during follow-up and prior to final diagnosis.Within 3 years of diagnosis of ovarian cystIncidence of ovarian torsion, cyst rupture and intra-abdominal hemorrhage requiring surgical intervention

Countries

Egypt

Contacts

Primary ContactSherif Shazly, MSc
sherif.shazly.mogge@gmail.com+4407554480388

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026