Ovarian CarcinomaNCT07267780
Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases.
An observational study of Ovarian Carcinoma and Cervical Carcinoma, run by National Cancer Institute, Naples at 2 sites in Italy.
Trial summary
Multicenter ambispective observational study (prospective/retrospective) Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Carcinoma, Cervical Carcinoma, Endometrial Carcinoma
- How many people
- 130 participants
- Where
- 2 sitesItaly
- Study dates
- Dec 2025to Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 20Show fewer
- 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
- Endometrial carcinoma
- Vulvar carcinoma
- Uterine or other types of sarcomas
- Documented major vascular invasion, confirmed by preoperative imaging or intraoperative description.
- Signed informed consent.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, Campania, 80131
Giuseppe Cucinella, MD
A.R.N.A.S. Ospedali Civico Di Cristina Benfratell
Palermo, Italy
Antonino Abbate, MD
About this study
Official title: The Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases: a Prospective and Retrospective Multicenter Study
Multicenter ambispective observational study (prospective/retrospective)
Read the detailed description
This multicenter ambispective observational study, including both a retrospective phase (patients treated surgically between January 1, 2017, and August 31, 2025) and a prospective phase, aims to evaluate the role of onco-vascular surgery in the treatment of advanced and recurrent gynecologic cancers. Onco-vascular surgery involves the simultaneous resection and reconstruction of major blood vessels when the tumor infiltrates or adheres firmly to them, and its benefits have been demonstrated in other malignancies such as hepatobiliary-pancreatic cancers and retroperitoneal soft tissue sarcomas. In the context of gynecologic oncology, this surgical approach is an emerging field with the potential to increase the rate of complete (R0) resection without increasing morbidity or mortality. However, data on the frequency, safety, and oncologic outcomes of vascular surgery in gynecologic oncology remain limited.
The study collects data on patient demographics, tumor characteristics, surgical details, postoperative complications, adjuvant therapies, oncologic outcomes, and quality of life (EORTC QLQ-C30).
Primary Objective: To describe overall survival in patients with advanced or recurrent gynecologic cancers undergoing onco-vascular surgery. Additionally, survival outcomes-including overall survival and 5-year progression-free survival-will be assessed for each patient subgroup, stratified by gynecologic cancer type and disease status (initial diagnosis vs. recurrence).
- Conditions
- Ovarian Carcinoma, Cervical Carcinoma, Endometrial Carcinoma, Vulvar Carcinoma, Uterine Sarcoma, Gynecologic Tumor
- Keywords
- Advanced or recurrent gynecologic tumor, Vascular infiltration
- Medical subject headings
- Ovarian Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Vulvar Neoplasms, Genital Neoplasms, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years from the date of surgery
Secondary outcomes (5)
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) at 5 years post-surgery Defined as the time from surgery to the first detection of recurrence or death, whichever occurs first. For patients without events, PFS will be censored at the date of the last follow-u
Measured: 5 years from the date of surgery
Frequency of early postoperative complications
Complications will be classified according to the Clavien-Dindo system
Measured: 30 days post-surgery
Frequency of late postoperative complications
Complications will be classified according to the Clavien-Dindo system.
Measured: 180 days post-surgery
Quality of Life assessment using the EORTC QLQ-C30 questionnaire
Questionnaire administration
Measured: Baseline (30 days pre-surgery) and 1 month, 3 months, 6 months ans 12 months post-surgery
Number of days of postoperative hospital stay
Measured: From the date of surgery until post-operative hospital discharge(assessed up to 30 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267780
- Sponsor's protocol ID
- ONCOVASCULAR SURGERY
- Status last verified
- Nov 2025
- First submitted
- 22 Sep 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases: a Prospective and Retrospective Multicenter Study
- ClinicalTrials.gov ID
- NCT07267780
- Acronym / sponsor ID
- ONCOVASCULAR SURGERY
- Conditions
- Ovarian Carcinoma, Cervical Carcinoma, Endometrial Carcinoma, Vulvar Carcinoma, Uterine Sarcoma, Gynecologic Tumor
- Keywords
- Advanced or recurrent gynecologic tumor, Vascular infiltration
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter ambispective observational study (prospective/retrospective)
Detailed description
This multicenter ambispective observational study, including both a retrospective phase (patients treated surgically between January 1, 2017, and August 31, 2025) and a prospective phase, aims to evaluate the role of onco-vascular surgery in the treatment of advanced and recurrent gynecologic cancers. Onco-vascular surgery involves the simultaneous resection and reconstruction of major blood vessels when the tumor infiltrates or adheres firmly to them, and its benefits have been demonstrated in other malignancies such as hepatobiliary-pancreatic cancers and retroperitoneal soft tissue sarcomas. In the context of gynecologic oncology, this surgical approach is an emerging field with the potential to increase the rate of complete (R0) resection without increasing morbidity or mortality. However, data on the frequency, safety, and oncologic outcomes of vascular surgery in gynecologic oncology remain limited.
The study collects data on patient demographics, tumor characteristics, surgical details, postoperative complications, adjuvant therapies, oncologic outcomes, and quality of life (EORTC QLQ-C30).
Primary Objective: To describe overall survival in patients with advanced or recurrent gynecologic cancers undergoing onco-vascular surgery. Additionally, survival outcomes-including overall survival and 5-year progression-free survival-will be assessed for each patient subgroup, stratified by gynecologic cancer type and disease status (initial diagnosis vs. recurrence).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (20 listed)
- Retrospective Arm:
- 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.)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival (OS)
Time frame: 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.
5 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 5 years from the date of surgery
Frequency of early postoperative complications
Time frame: 30 days post-surgery
Frequency of late postoperative complications
Time frame: 180 days post-surgery
Quality of Life assessment using the EORTC QLQ-C30 questionnaire
Time frame: Baseline (30 days pre-surgery) and 1 month, 3 months, 6 months ans 12 months post-surgery
Number of days of postoperative hospital stay
Time frame: From the date of surgery until post-operative hospital discharge(assessed up to 30 days after surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Carcinoma and Cervical Carcinoma, run by National Cancer Institute, Naples at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Cucinella, MD (0000000000, giuseppe.cucinella@istitutotumori.na.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: 5 years from the date of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.