Ovarian MassNCT07416435
Concordance Between Radiologic Laparoscopic and Laparotomic Evaluation for Complete Cytoreduction of Ovarian Masses
An observational study of Ovarian Mass, run by Assiut University.
Trial summary
Ovarian mass occur in women of all ages, and their etiology and frequency range age accordingly. The ovarian mass may come from functional or physiological changes, inflammatory processes, endometriosis, benign and malignant tumor(1). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Mass
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Dec 2027
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: primary ovarian cancer patients with no extraperitoneal metastatic disease and candidates for primary debulking surgery
Who may be able to join
- • women aged >18 years
- patients with primary ovarian cancer eligible for CRS
- primary ovarian cancer patients with no extraperitoneal metastatic disease
Who cannot join
- • patients with significant comorbidities (hepatic or renal failure, severe cardiovascular or pulmonary patients with hepatic metastases
- newly diagnosed pulmonary embolism.
- criteria set by Aletti and colleagues (age >75 years, serum albumin 3.0 g/dL, and American Society of Anesthesiologists classification score ≥3 or extensive disease).
- Unresectable stage IVB disease found on preoperative imaging which defined as multiple parenchymal liver metastases, pulmonary metastases including diffuse pleural involvement, brain metastases, or bulky thoracic adenopathy (not including anterior, lateral, or posterior cardiophrenic lymphade nopathy).
- Patients who received initial treatment elsewhere or is known non-epithelial ovarian carcinoma histology on pathology
- patients refused to participate in study
About this study
Ovarian mass occur in women of all ages, and their etiology and frequency range age accordingly. The ovarian mass may come from functional or physiological changes, inflammatory processes, endometriosis, benign and malignant tumor(1).
Ovarian cancer (OC), the most lethal gynecological malignancy, usually presents in advanced stages. Characterized by peritoneal and lymphatic dissemination, OC necessitates a complex surgical approach usually involving the upper abdomen with the aim of achieving optimal cytoreduction without visible macroscopic disease (R0)(2).
Read more
The presence of a residual tumor at the end of surgery is indeed recognized as the main negative prognostic factor for patients with AOC. In this context, complete cytoreductive surgery (R0) achieving no gross residual disease is associated with the best survival outcomes(3).
Despite the increasing adoption of diagnostic laparoscopy, laparotomic assessment during definitive cytoreductive surgery remains the gold standard for evaluating the true extent of disease and determining resectability(4).
Over the years, different score systems have been proposed and evaluated, aiming to assess the peritoneal spread of the disease and predict whether it is possible to obtain R0. Several imaging-based scoring models, using computed tomography (CT), have been suggested to predict the outcomes of PDS. These models included different radiological criteria, such as peritoneal thickening, ascites, para-aortic lymphadenopathy, and bowel involvement. Although the overall good predictive performance, the main limitation is represented by the unsuccessful rate when cross-validations datasets were used(3).
Staging laparoscopy has shown to be a minimally invasive tool able to properly drive the therapeutic choice between primary cytoreductive surgery and neoadjuvant chemotherapy. To quickly select candidates for upfront surgery, and to decrease the delay to cytoreductive surgery or neoadjuvant chemotherapy, we offer patients a two-step surgical management protocol in which diagnostic laparoscopy is performed a few weeks prior to cytoreductive surgery(5).
a laparoscopic scoring algorithm (predictive index, (PI) which developed by Fagotti et al.2015 including seven parameters based on intra-abdominal distribution of the disease. Although the accuracy of the laparoscopic model is 75% at predicting surgical outcome, the percentage of unnecessary laparotomies remains 33%, even after the inclusion of upper abdominal surgical score. Moreover, concordance between PI scores and PDS varies by anatomical location, with the lowest concordance in predicting bowel infiltration(6).
- Conditions
- Ovarian Mass
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 |
|---|---|---|
| Patients with ovarian mass who are candidates for primary debulking surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical complexity
Surgical complexity will be graded as low (≤3), intermediate (4-7), and high (≥8).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian MassStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Mohamed Abd El Halim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416435
- Sponsor's protocol ID
- laparoscopic and laparotomicOM
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 18 Feb 2026
- 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 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance Between Radiologic Laparoscopic and Laparotomic Evaluation for Complete Cytoreduction of Ovarian Masses
- ClinicalTrials.gov ID
- NCT07416435
- Acronym / sponsor ID
- laparoscopic and laparotomicOM
- Conditions
- Ovarian Mass
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Feb 2026 (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 mass occur in women of all ages, and their etiology and frequency range age accordingly. The ovarian mass may come from functional or physiological changes, inflammatory processes, endometriosis, benign and malignant tumor(1).
Ovarian cancer (OC), the most lethal gynecological malignancy, usually presents in advanced stages. Characterized by peritoneal and lymphatic dissemination, OC necessitates a complex surgical approach usually involving the upper abdomen with the aim of achieving optimal cytoreduction without visible macroscopic disease (R0)(2).
The presence of a residual tumor at the end of surgery is indeed recognized as the main negative prognostic factor for patients with AOC. In this context, complete cytoreductive surgery (R0) achieving no gross residual disease is associated with the best survival outcomes(3).
Despite the increasing adoption of diagnostic laparoscopy, laparotomic assessment during definitive cytoreductive surgery remains the gold standard for evaluating the true extent of disease and determining resectability(4).
Over the years, different score systems have been proposed and evaluated, aiming to assess the peritoneal spread of the disease and predict whether it is possible to obtain R0. Several imaging-based scoring models, using computed tomography (CT), have been suggested to predict the outcomes of PDS. These models included different radiological criteria, such as peritoneal thickening, ascites, para-aortic lymphadenopathy, and bowel involvement. Although the overall good predictive performance, the main limitation is represented by the unsuccessful rate when cross-validations datasets were used(3).
Staging laparoscopy has shown to be a minimally invasive tool able to properly drive the therapeutic choice between primary cytoreductive surgery and neoadjuvant chemotherapy. To quickly select candidates for upfront surgery, and to decrease the delay to cytoreductive surgery or neoadjuvant chemotherapy, we offer patients a two-step surgical management protocol in which diagnostic laparoscopy is performed a few weeks prior to cytoreductive surgery(5).
a laparoscopic scoring algorithm (predictive index, (PI) which developed by Fagotti et al.2015 including seven parameters based on intra-abdominal distribution of the disease. Although the accuracy of the laparoscopic model is 75% at predicting surgical outcome, the percentage of unnecessary laparotomies remains 33%, even after the inclusion of upper abdominal surgical score. Moreover, concordance between PI scores and PDS varies by anatomical location, with the lowest concordance in predicting bowel infiltration(6).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ovarian mass who are candidates for primary debulking surgery | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary ovarian cancer patients with no extraperitoneal metastatic disease and candidates for primary debulking surgery
Key inclusion criteria (3 listed)
- • women aged >18 years
Key exclusion criteria (6 listed)
- • patients with significant comorbidities (hepatic or renal failure, severe cardiovascular or pulmonary patients with hepatic metastases
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
Surgical complexity
Time frame: baseline
Surgical complexity will be graded as low (≤3), intermediate (4-7), and high (≥8).
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 18 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Mass, run by Assiut University.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Surgical complexity (time frame: baseline). 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 Feb 2026.