Clinical trial · Observational
Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases.
The Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases: a Prospective and Retrospective Multicenter Study
NCT07267780CI-TRIAL-00098479not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Multicenter ambispective observational study (prospective/retrospective)
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Carcinoma | Cervical Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Endometrial Carcinoma | Endometrial Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Gynecologic Tumor | Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Ovarian Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Uterine Sarcoma | Uterine Corpus Sarcoma | ALIAS | 0.90 |
| Vulvar Carcinoma | Vulvar Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Retrospective Arm (30 patients)
- description
- Includes patients who underwent surgical treatment in the 8 years prior to the prospective study (January 1, 2017 - August 31, 2025).
- label
- Prospective Arm (100 patients)
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- 5 years from the date of surgery
- description
- Overall Survival (OS) at 5 years post-surgery, defined as the time from the surgical intervention to death from any cause. For patients who are still alive, OS will be censored at the date of the last follow-up.
Secondary outcomes (5)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- 5 years from the date of surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- Retrospective Arm: 1. Diagnosis of advanced or recurrent gynecologic cancer with vascular involvement requiring resection and/or reconstruction of major blood vessels, including: * Ovarian carcinoma * Cervical carcinoma * Endometrial carcinoma * Vulvar carcinoma * Uterine or other types of sarcomas with vascular involvement 2. Documented major vascular invasion, confirmed by preoperative imaging or intraoperative description. 3. Patients who underwent onco-vascular surgery for advanced or recurrent gynecologic cancers between January 1, 2017, and August 31, 2025. 4. Data Protection Impact Assessment (DPIA) approved for the management of retrospective data. (Deceased or untraceable patients will also be included to avoid selection bias, in accordance with Article 110 bis, paragraph 4 of the Italian Privacy Code. A DPIA will be produced and published on the Sponsor's website before study initiation, and patients who explicitly objected before death will not be included.) Prospective Arm: 1. Age ≥18 years 2. Patients eligible for onco-vascular surgery for advanced or recurrent gynecologic cancers with vascular involvement, including: * Ovarian carcinoma * Cervical carcinoma * Endometrial carcinoma * Vulvar carcinoma * Uterine or other types of sarcomas 3. Documented major vascular invasion, confirmed by preoperative imaging or intraoperative description. 4. Signed informed consent. Exclusion Criteria: 1. Patients younger than 18 years of age 2. Patients with early-stage gynecologic cancers not eligible for onco-vascular surgery 3. Patients undergoing vascular resection due to accidental injury of blood vessels not directly related to tumor infiltration. 4. Patients who have previously undergone vascular surgery for reasons unrelated to the study, to avoid data overlap.
References
Publications (0)
Data not yet available
No reference posted for this study.