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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-28

Study Completion Date

2031-02-28

Brief Summary

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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.

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Detailed Description

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Cervical cancer is the most prevalent gynecologic malignancy worldwide, with poor prognosis particularly in patients diagnosed with locally advanced cervical cancer (LACC; FIGO stage IB3-IVA). Although peritoneal metastasis is not included in FIGO staging, it is considered as a distant metastasis. Several studies have reported peritoneal disease in about 20% of LACC patients undergoing diagnostic laparoscopy, suggesting a potential role for laparoscopy in staging. However, the benefit of laparoscopy in surgical staging is controversial and the impact of peritoneal involvement on prognosis remains unclear.

This is a prospective, observational, single-center study. The primary objective is to assess the prevalence of peritoneal metastasis in specific subgroups of LACC patients (AJCC stage T3/T4, grade 3 cervical cancer, FIGO stage IIIC2) using diagnostic laparoscopy. Secondary objectives include evaluating 3-year disease-free survival (DFS), overall survival (OS), and treatment response rates to exclusive chemoradiotherapy (if pelvic peritoneal involvement, FIGO IVA) and chemo-immunotherapy (if upper abdominal peritoneal involvement, FIGO IVB) in patients with peritoneal metastasis.

Conditions

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Cervical Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Diagnostic laparoscopy

Intervention Type PROCEDURE

Diagnostic laparoscopy with peritoneal biopsies

Interventions

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Diagnostic laparoscopy

Diagnostic laparoscopy with peritoneal biopsies

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Patients with previous diagnosis of other cancers
* Performance status ECOG \>2
* Pregnant women
* Contraindications to diagnostic laparoscopy
* Recurrent cervical cancer

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR