Clinical Trials in Italy / NCT07267780
Starting soon
Observational
Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases.
NCT07267780 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Ovarian CarcinomaCervical CarcinomaEndometrial CarcinomaVulvar CarcinomaUterine SarcomaGynecologic Tumor
Study summary
Multicenter ambispective observational study (prospective/retrospective)
Eligibility
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.
Primary outcome measure(s)
- Overall Survival (OS) — 5 years from the date of surgery
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.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Istituto Nazionale Tumori IRCCS Fondazione G. Pascale | Naples | Campania | |
| A.R.N.A.S. Ospedali Civico Di Cristina Benfratell | Palermo | Italy |
More National Cancer Institute, Naples trials in Italy
Other trials for the same condition
Endometrial Carcinoma: Comparison of Surgical Approaches (Laparoscopy vs Laparotomy)
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07267780 on ClinicalTrials.gov ↗ ← All trials in Italy