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NCT06832397Not yet recruiting

Detection of Peritoneal Metastases by Diagnostic LAparoscopy in Patients With Locally Advanced Cervical Carcinoma

Prospective Observational Study On the Detection of Peritoneal Metastases by Diagnostic LAparoscopy in Specific Subgroups of Patients With Locally Advanced Cervical canceR

Source: ClinicalTrials.gov · Last updated 18 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
120 (estimated)
First submitted
12 Feb 2025
Start date
Feb 2025
Primary completion date
Feb 2028
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NCT number
NCT06832397

What you commit to

  • Study type: Observational
  • Planned participants: 120
  • From Feb 2025 to the primary completion date, Feb 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with previous diagnosis of other cancers

Other illness

  • Recurrent cervical cancer

Other

  • Performance status ECOG \>2
  • Pregnant women
  • Contraindications to diagnostic laparoscopy

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Policlinico Agostino Gemelli IRCCS
Coordinator of this site? Confirm its status
RomeItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.