Complex Ovarian CystNCT07005089
Diagnostic Accuracy of Ultrasound and Tumors Markers in Diagnosis of Complex Ovarian Cysts
A study testing Laparotomy or laparoscopic ovarian cystectomy in people with Complex Ovarian Cyst, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Cystic ovarian lesions are more common in adolescences due to onset of hormonal activity in prepubertal age. Most cysts are functional but a malignant etiology must nevertheless always be eliminated. Most ovarian cysts in adolescents are benign in nature, with 60% being simple ovarian cysts. Read more about this study
- Who is it for?
- Ages 11 to 21 years, women only
- Conditions the study is for
- Complex Ovarian Cyst
- What is being tested?
- Laparotomy or laparoscopic ovarian cystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2023to 10 Oct 2024
- Phase
- Interventional
- 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 11 to 21 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female patients diagnosed by complex ovarian cysts
Who cannot join
- simple ovarian cyst < 7cm
- Any suspected ovarian malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Accuracy of Ultrasound and Tumors Markers in Diagnosis of Complex Ovarian Cysts in Adolescent, Histopathological Correlation
Cystic ovarian lesions are more common in adolescences due to onset of hormonal activity in prepubertal age. Most cysts are functional but a malignant etiology must nevertheless always be eliminated.
Most ovarian cysts in adolescents are benign in nature, with 60% being simple ovarian cysts.
Cystic neoplasia may be benign, borderline, or malignant. The large majority are benign or borderline, accounting for 80% and 16%, respectively
Read the detailed description
Cystic ovarian lesions are more common in adolescences due to onset of hormonal activity in prepubertal age. Most cysts are functional but a malignant etiology must nevertheless always be eliminated.
Complex benign cysts are about 16% of all ovarian cysts, :(mature cystic teratoma 55-70%, endometrioma, gonadoblastoma, serous cystadenoma, mucinous cystadenoma, cystadenofibroma).
About 1% of ovarian tumors can be malignant and differential diagnosis with benign ones is sometimes difficult. Concerning the management of such tumors in adolescents for which future fertility is a concern.
Malignant ovarian tumors types are :( Sex cord-stromal tumors:( juvenile granulosa cell tumor is most common about 50% and Sertoli-Leydig cell tumor), Germ cell tumors: (dysgerminoma30%, immature teratoma30%, yolk sac tumor, embryonal carcinoma and polyembryoma) and Epithelial tumors:(serous adenocarcinoma, mucinous adenocarcinoma).
Ultrasonography is a gold standard modality in the evaluation of the female pelvis in adolescence today the method of choice for distinguishing between benign and malignant adnexal pathologies. Using pattern of recognition several types of cysts and tumors can be recognized according to their characteristic appearance.
If a complex ovarian cyst is diagnosed on an ultrasound scan, magnetic resonance imaging (MRI) of the pelvis should be requested. MRI provides good soft tissue delineation and allows identification of the ovarian tumor type, MRI had excellent performance and positive correlation, but significant interobserver variability remains.
The discovery of reliable ovarian cancer biomarkers plays a crucial role in the disease diagnosis, management and strongly impact in patient's prognosis and survival as (lactate dehydrogenase, beta human chorionic gonadotrophin, alpha fetoprotein and ca-125).
Lactate dehydrogenase is widely recognized that the increased rate of glycolysis in rapidly growing tumor as Dysgerminoma and Immature teratoma.
Alpha fetoprotein (AFP) and ß-human chorion gonadotropin (ß-HCG) are markers of tumorous lesions of the ovary. AFP can be a marker of immature ovarian teratoma, yolk sac tumor, and embryonal carcinoma. ß-HCG can be a marker of malignant germ cell tumors, choriocarcinoma, and embryonal cell carcinomas.
CA-125 The most extensively studied ovarian cancer associated marker which detecting Epithelial tumors.
Final diagnoses only by histopathological examination, Ovarian cancer is a very heterogeneous disease and is mainly represented four main distinct histological subtypes: serous, the most frequent; endometrioid; mucinous and clear cells. In some cases, it is present a mixture of these histological types. Each of these histological subtypes may exhibit a different degree of differentiation.
- Conditions
- Complex Ovarian Cyst
- Being tested
- Laparotomy or laparoscopic ovarian cystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparotomy or laparoscopic ovarian cystectomyProcedure or surgery
Also called ultrasound and tumors markers
to evaluate diagnostic accuracy of ultrasound and tumors markers in diagnosis of complex ovarian cysts in adolescent with histopathological correlation.
| Study group | Role | What they receive |
|---|---|---|
| Cases with Complex Ovarian Cyst | Experimental | About 48 female patients suffered from Complex Ovarian Cysts. tumor marker and MRI should be done. If no suspicion of cancer by tumor markers and the patient was Symptomatic and the size of the cysts >5 cm: Laparotomy or Laparoscopic cystectomy and histopathological examination were done. Receives: Procedure: Laparotomy or laparoscopic ovarian cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of Complex Ovarian Cysts
Assessment and Diagnosis of female patients with Complex Ovarian Cysts by ultrasound or tumor markers
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start10 Feb 2023
- Primary completion1 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Ovarian CystStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Fathy Ibrahim Mohamed, Al-Azhar University
- Investigators
- El kotb Hassan El kotb El saedy, Professor, Study chair, Al-Azhar Faculty of medicine,Assuit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005089
- Sponsor's protocol ID
- Complex Ovarian Cysts
- Status last verified
- Feb 2023
- First submitted
- 27 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Ultrasound and Tumors Markers in Diagnosis of Complex Ovarian Cysts in Adolescent, Histopathological Correlation
- ClinicalTrials.gov ID
- NCT07005089
- Acronym / sponsor ID
- Complex Ovarian Cysts
- Conditions
- Complex Ovarian Cyst
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 5 Jun 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.
Cystic ovarian lesions are more common in adolescences due to onset of hormonal activity in prepubertal age. Most cysts are functional but a malignant etiology must nevertheless always be eliminated.
Most ovarian cysts in adolescents are benign in nature, with 60% being simple ovarian cysts.
Cystic neoplasia may be benign, borderline, or malignant. The large majority are benign or borderline, accounting for 80% and 16%, respectively
Detailed description
Cystic ovarian lesions are more common in adolescences due to onset of hormonal activity in prepubertal age. Most cysts are functional but a malignant etiology must nevertheless always be eliminated.
Complex benign cysts are about 16% of all ovarian cysts, :(mature cystic teratoma 55-70%, endometrioma, gonadoblastoma, serous cystadenoma, mucinous cystadenoma, cystadenofibroma).
About 1% of ovarian tumors can be malignant and differential diagnosis with benign ones is sometimes difficult. Concerning the management of such tumors in adolescents for which future fertility is a concern.
Malignant ovarian tumors types are :( Sex cord-stromal tumors:( juvenile granulosa cell tumor is most common about 50% and Sertoli-Leydig cell tumor), Germ cell tumors: (dysgerminoma30%, immature teratoma30%, yolk sac tumor, embryonal carcinoma and polyembryoma) and Epithelial tumors:(serous adenocarcinoma, mucinous adenocarcinoma).
Ultrasonography is a gold standard modality in the evaluation of the female pelvis in adolescence today the method of choice for distinguishing between benign and malignant adnexal pathologies. Using pattern of recognition several types of cysts and tumors can be recognized according to their characteristic appearance.
If a complex ovarian cyst is diagnosed on an ultrasound scan, magnetic resonance imaging (MRI) of the pelvis should be requested. MRI provides good soft tissue delineation and allows identification of the ovarian tumor type, MRI had excellent performance and positive correlation, but significant interobserver variability remains.
The discovery of reliable ovarian cancer biomarkers plays a crucial role in the disease diagnosis, management and strongly impact in patient's prognosis and survival as (lactate dehydrogenase, beta human chorionic gonadotrophin, alpha fetoprotein and ca-125).
Lactate dehydrogenase is widely recognized that the increased rate of glycolysis in rapidly growing tumor as Dysgerminoma and Immature teratoma.
Alpha fetoprotein (AFP) and ß-human chorion gonadotropin (ß-HCG) are markers of tumorous lesions of the ovary. AFP can be a marker of immature ovarian teratoma, yolk sac tumor, and embryonal carcinoma. ß-HCG can be a marker of malignant germ cell tumors, choriocarcinoma, and embryonal cell carcinomas.
CA-125 The most extensively studied ovarian cancer associated marker which detecting Epithelial tumors.
Final diagnoses only by histopathological examination, Ovarian cancer is a very heterogeneous disease and is mainly represented four main distinct histological subtypes: serous, the most frequent; endometrioid; mucinous and clear cells. In some cases, it is present a mixture of these histological types. Each of these histological subtypes may exhibit a different degree of differentiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases with Complex Ovarian Cyst | Experimental | Procedure: Laparotomy or laparoscopic ovarian cystectomyAbout 48 female patients suffered from Complex Ovarian Cysts. tumor marker and MRI should be done. If no suspicion of cancer by tumor markers and the patient was Symptomatic and the size of the cysts >5 cm: Laparotomy or Laparoscopic cystectomy and histopathological examination were done. |
Who may qualify
- Ages
- 11 to 21 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Female patients diagnosed by complex ovarian cysts
Key exclusion criteria (2 listed)
- simple ovarian cyst < 7cm
- Any suspected ovarian malignancy
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 |
|---|---|---|
| Laparotomy or laparoscopic ovarian cystectomyAlso: ultrasound and tumors markersto evaluate diagnostic accuracy of ultrasound and tumors markers in diagnosis of complex ovarian cysts in adolescent with histopathological correlation. | Procedure or surgery | Cases with Complex Ovarian Cyst |
Primary outcome
Diagnosis of Complex Ovarian Cysts
Time frame: 3 months
Assessment and Diagnosis of female patients with Complex Ovarian Cysts by ultrasound or tumor markers
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 5 Jun 2025.
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RecruitingObservational study
Familial Investigations of Childhood Cancer Predisposition
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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.
El kotb Hassan El kotb El saedy, Professor study chair
Al-Azhar Faculty of medicine,Assuit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparotomy or laparoscopic ovarian cystectomy in people with Complex Ovarian Cyst, run by Al-Azhar 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 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 5 Jun 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 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?
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?
Diagnosis of Complex Ovarian Cysts (time frame: 3 months). 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 5 Jun 2025.