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

NCT07267780 | Not Yet Recruiting

• 1 other identifier: ONCOVASCULAR SURGERY
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

Multicenter ambispective observational study (prospective/retrospective)

Conditions

Ovarian Carcinoma; Cervical Carcinoma; Endometrial Carcinoma; Vulvar Carcinoma; Uterine Sarcoma; Gynecologic Tumor

Keywords

Advanced or recurrent gynecologic tumor; Vascular infiltration

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  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.

  5 years from the date of surgery

Secondary Outcomes (5)

• Progression-Free Survival (PFS)

  5 years from the date of surgery

• Frequency of early postoperative complications

  30 days post-surgery

• Frequency of late postoperative complications

  180 days post-surgery

• Quality of Life assessment using the EORTC QLQ-C30 questionnaire

  Baseline (30 days pre-surgery) and 1 month, 3 months, 6 months ans 12 months post-surgery

• Number of days of postoperative hospital stay

  From the date of surgery until post-operative hospital discharge(assessed up to 30 days after surgery)

Study Arms (2)

Retrospective Arm (30 patients)

Includes patients who underwent surgical treatment in the 8 years prior to the prospective study (January 1, 2017 - August 31, 2025).

Prospective Arm (100 patients)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population of the study consists of patients with advanced or recurrent gynecologic cancers involving major blood vessels by continuity or contiguity, who undergo en bloc tumor resection with simultaneous vascular resection and reconstruction during surgery for disease management.

You may qualify if:

• \- Retrospective Arm:
• 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
• 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.)
• Prospective Arm:
• Age ≥18 years
• Patients eligible for onco-vascular surgery for advanced or recurrent gynecologic cancers with vascular involvement, including:
• Ovarian carcinoma
• Cervical carcinoma

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (2)

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Naples, Campania, 80131, Italy

Location

A.R.N.A.S. Ospedali Civico Di Cristina Benfratell

Palermo, Italy, Italy

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms; Vulvar Neoplasms; Genital Neoplasms, Female

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Vulvar Diseases

Central Study Contacts

Giuseppe Cucinella, MD

CONTACT

0000000000; giuseppe.cucinella@istitutotumori.na.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: December 5, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2035
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

IT (2)