Checks for cancer spread in the belly using keyhole surgery in cervical cancer
Looks at keyhole surgery to detect belly spread in adults with advanced cervical cancer.
Key facts
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Where
- Rome, ItalySee the site
- Trial code
- Registry title
- Detection of Peritoneal Metastases by Diagnostic LAparoscopy in Patients With Locally Advanced Cervical Carcinoma
- Status
- Not yet recruiting
- People taking part
- 120 people, planned
- Started
- Feb 2025
- Expected to end
- Feb 2031
- Type of study
- Observational
- Treatments tested
- Diagnostic laparoscopy
- Record updated
- 18 February 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with locally advanced cervical cancer in higher-risk groups. It checks for cancer spread inside the belly using a diagnostic laparoscopy.
- Age
- Older than 18 years.
- Sex
- Women only.
- Disease stage
- Cervical cancer AJCC stage T3/T4, or FIGO stage IB3 and IIA2-IVA grade 3, or FIGO stage IIIC2 (cancer in para-aortic lymph nodes). All cervical cancer cell types can join. The stage is set by the local Multidisciplinary Board.
- Biomarker or test result
- Para-aortic lymph nodes count as affected when the short axis is > 10 mm on MRI and/or SUV max >2.5 on PET/CT.
Main reasons for not taking part
- Earlier diagnosis of another cancer
- ECOG performance status >2
- Pregnancy
- Reasons why diagnostic laparoscopy is not safe
- Cervical cancer that has come back
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Cervical cancer AJCC stage T3/T4 and/or
- Cervical cancer FIGO stage IB3 and IIA2-IVA grade 3 and/or
- Cervical cancer FIGO stage IIIC2 (para-aortic lymph node metastasis). Lymph node will be considered pathologic when the short axis diameter is > 10 mm at MRI scan and/or SUV max >2.5 at PET/CT-scan
- All cervical histology sub-types will be included
- Stage assessment according to local Multidisciplinary Board
- Age >18 years
- Signature informed consent or substitute declaration on the consent form where applicable
Who cannot take part
- Patients with previous diagnosis of other cancers
- Recurrent cervical cancer
- Performance status ECOG >2
- Pregnant women
- Contraindications to diagnostic laparoscopy
Where in Italy
- Policlinico Agostino Gemelli IRCCSRome, ItalyContact: Nicolò Bizzarri, MDNo longer taking part
About the trial
What the trial wants to find out
The study hypothesizes that specific subgroups of LACC patients, (AJCC stage T3/T4, grade 3 tumors, and para-aortic lymph node involvement), have a higher prevalence of peritoneal metastasis. This peritoneal spread may serve as a prognostic factor, and diagnostic laparoscopy could improve staging accuracy, thereby guiding personalized treatment strategies and improving oncological outcomes.
The group in the trial
- LACC patients with high-risk of peritoneal metastasis
Locally advanced cervical cancer patients with high-risk of peritoneal metastasis (AJCC stage T3/T4; grade 3 cervical cancer. all histotypes; FIGO stage IIIC2).
Treatment: Diagnostic laparoscopy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Prospective Observational Study On the Detection of Peritoneal Metastases by Diagnostic LAparoscopy in Specific Subgroups of Patients With Locally Advanced Cervical canceR
- Plain-language title
- Checks for cancer spread in the belly using keyhole surgery in cervical cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 18 February 2025