Not Yet RecruitingNot Applicable

Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases.

Italy130 participantsStarted 2025-12

Plain-language summary

Multicenter ambispective observational study (prospective/retrospective)

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Diagnosis of advanced or recurrent gynecologic cancer with vascular involvement requiring resection and/or reconstruction of major blood vessels, including:
✓. Documented major vascular invasion, confirmed by preoperative imaging or intraoperative description.
✓. Patients who underwent onco-vascular surgery for advanced or recurrent gynecologic cancers between January 1, 2017, and August 31, 2025.
✓. 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.)
✓. Age ≥18 years
✓. Patients eligible for onco-vascular surgery for advanced or recurrent gynecologic cancers with vascular involvement, including:
✓. Documented major vascular invasion, confirmed by preoperative imaging or intraoperative description.
✓. Signed informed consent.

✕. Patients younger than 18 years of age
✕. Patients with early-stage gynecologic cancers not eligible for onco-vascular surgery
✕. Patients undergoing vascular resection due to accidental injury of blood vessels not directly related to tumor infiltration.
✕. Patients who have previously undergone vascular surgery for reasons unrelated to the study, to avoid data overlap.

Overall Survival (OS)

Timeframe: 5 years from the date of surgery

NCT IDNCT07267780

SponsorNational Cancer Institute, Naples

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-12

Giuseppe Cucinella, MD

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Diagnosis of advanced or recurrent gynecologic cancer with vascular involvement requiring resection and/or reconstruction of major blood vessels, including:
✓. Documented major vascular invasion, confirmed by preoperative imaging or intraoperative description.
✓. Patients who underwent onco-vascular surgery for advanced or recurrent gynecologic cancers between January 1, 2017, and August 31, 2025.
✓. 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.)
✓. Age ≥18 years
✓. Patients eligible for onco-vascular surgery for advanced or recurrent gynecologic cancers with vascular involvement, including:
✓. Documented major vascular invasion, confirmed by preoperative imaging or intraoperative description.
✓. Signed informed consent.

✕. Patients younger than 18 years of age
✕. Patients with early-stage gynecologic cancers not eligible for onco-vascular surgery
✕. Patients undergoing vascular resection due to accidental injury of blood vessels not directly related to tumor infiltration.
✕. Patients who have previously undergone vascular surgery for reasons unrelated to the study, to avoid data overlap.