Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:36 PM
Study NCT ID:
NCT07416435
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concordance Between Radiologic Laparoscopic and Laparotomic Evaluation for Complete Cytoreduction of Ovarian Masses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-15', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-15', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical complexity', 'timeFrame': 'baseline', 'description': 'Surgical complexity will be graded as low (≤3), intermediate (4-7), and high (≥8).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Mass']}, 'descriptionModule': {'briefSummary': '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).\n\nOvarian 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).\n\nThe 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).\n\nDespite 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).\n\nOver 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).\n\nStaging 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).\n\na 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).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'primary ovarian cancer patients with no extraperitoneal metastatic disease and candidates for primary debulking surgery', 'genderDescription': 'female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • women aged \\>18 years\n\n * patients with primary ovarian cancer eligible for CRS\n * primary ovarian cancer patients with no extraperitoneal metastatic disease\n\nExclusion Criteria:\n\n* • patients with significant comorbidities (hepatic or renal failure, severe cardiovascular or pulmonary patients with hepatic metastases\n\n * newly diagnosed pulmonary embolism.\n * 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).\n * 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).\n * Patients who received initial treatment elsewhere or is known non-epithelial ovarian carcinoma histology on pathology\n * patients refused to participate in study'}, 'identificationModule': {'nctId': 'NCT07416435', 'briefTitle': 'Concordance Between Radiologic Laparoscopic and Laparotomic Evaluation for Complete Cytoreduction of Ovarian Masses', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Concordance Between Radiologic Laparoscopic and Laparotomic Evaluation for Complete Cytoreduction of Ovarian Masses', 'orgStudyIdInfo': {'id': 'laparoscopic and laparotomicOM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with ovarian mass who are candidates for primary debulking surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'residant doctor at Assiut university hospital', 'investigatorFullName': 'Mohamed Ahmed Mohamed Abd El Halim', 'investigatorAffiliation': 'Assiut University'}}}}