ClinicalTrials.gg
CompletedNCT07005089Updated Jun 5, 2025

Diagnostic Accuracy of Ultrasound and Tumors Markers in Diagnosis of Complex Ovarian Cysts

An interventional study of Laparotomy or laparoscopic ovarian cystectomy in Complex Ovarian Cyst, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to female participants aged 11 Years to 21 Years. Per ClinicalTrials.gov, last updated 2025-06-05.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Feb 2023, registered May 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
11 Years to 21 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Ovarian Cysts with a site in Egypt — 2 open to participants now, 2 under way, none of them phase 3. Ovarian Cysts · Egypt.

Started
2023
with 1 other
No phase
8 of 10
2 open now
Registered
8th of 10
by date
Lead sponsor
2 of 10
Al-Azhar University

Among the 10 studies in Ovarian Cysts with a site in Egypt, this one is one of 2 that started in 2023, is one of 8 with no phase, and was the 8th registered.

Ovarian Cysts

80 studies on the registry are indexed under Ovarian Cysts; 16 are open to participants now.

Browse Ovarian Cysts studies →

Open to participants now

2 of the 10 studies in Ovarian Cysts with a site in Egypt are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 12 Ovarian Cysts studies recruiting now, 4 (33%) set no upper age limit and 7 (58%) stop at 75 or younger; 3 take children under 18; 3 take healthy volunteers.

This study: 11 Years to 21 Years · female · no healthy volunteers.

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02

Study 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.

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.

03

Conditions studied

  • Complex Ovarian Cyst

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04

Who can participate

Ages eligible
11 Years to 21 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female patients diagnosed by complex ovarian cysts

Exclusion criteria

Exclusion Criteria:

  • simple ovarian cyst \< 7cm
  • Any suspected ovarian
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Cases with Complex Ovarian Cyst

    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.

    Procedure: Laparotomy or laparoscopic ovarian cystectomy

Interventions

  • ProcedureLaparotomy or laparoscopic ovarian cystectomy

    to evaluate diagnostic accuracy of ultrasound and tumors markers in diagnosis of complex ovarian cysts in adolescent with histopathological correlation.

    Also known as: ultrasound and tumors markers

06

What researchers measure

Primary outcomes

  1. Diagnosis of Complex Ovarian Cysts

    Assessment and Diagnosis of female patients with Complex Ovarian Cysts by ultrasound or tumor markers

    Time frame: 3 months

07

Study locations

1 site
  • Al-Azhar University hospital
    Assiut, Egypt
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2023 to primary completion in Oct 2024, 19 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 27, 2025
First posted
Jun 5, 2025
StartActual
Feb 10, 2023
Primary completionActual
Oct 1, 2024
CompletionActual
Oct 10, 2024
Last update
Jun 5, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07005089
Responsible party
Ahmed Fathy Ibrahim Mohamed (Resident of Obstetrics and Gynecology, Al-Azhar University) — Principal investigator
First posted
Jun 5, 2025
Start date
Feb 10, 2023
Primary completion
Oct 1, 2024
Completion
Oct 10, 2024
Last update
Jun 5, 2025

Study contacts

El kotb Hassan El kotb El saedy, Professor
study chair · Al-Azhar Faculty of medicine,Assuit

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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