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Clinical Trials/NCT06039982
NCT06039982
Not yet recruiting
Not Applicable

Establish a New Noninvasive Diagnostic Model Based on Clinical Indicators to Evaluate the Vaginal Invasion in Cervical Cancer Patients

Fujian Cancer Hospital1 site in 1 country100 target enrollmentNovember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cervix Carcinoma
Sponsor
Fujian Cancer Hospital
Enrollment
100
Locations
1
Primary Endpoint
vaginal invasion
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

This study aims to develop a diagnostic nomogram based on clinical factors with the prediction values of vaginal invasion in cervical cancer to optimize the treatment plan and surgical procedures.

Detailed Description

Vaginal invasion is a crucial index participant in cervical cancer tumor staging and prognosis prediction. However, the roles of vaginal invasion are overlooked in the literature, compared with those of lymph node metastasis and parametrial invasion. As far as we know, this study is novel to construct a nomogram to predict the probability of pathologic vaginal invasion occurrence.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
November 1, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Pathologically confirmed cervical cancer;
  • FIGO2018 stage IB-IIA according to the result of physical examination and images;
  • No preoperative treatment before surgery;
  • Abdominal MRI is performed within three weeks before surgery. Blood routine, biochemistry, blood tumor markers and coagulation function were examined within 1 week before surgery.
  • All patients undergo radical hysterectomy (RH) with bilateral pelvic lymphadenectomy or paraaortic lymph node dissection.

Exclusion Criteria

  • Accompanied with other tumors;
  • Accompanied with chronic infectious and immune diseases;
  • Incomplete clinical data.

Outcomes

Primary Outcomes

vaginal invasion

Time Frame: 7 days after surgery

100 cervical cancer patients who underwent radical hysterectomy (RH) with bilateral pelvic lymphadenectomy were pathologically assessed for vaginal invasion. The primary outcome is vaginal invasion or no-vaginal invasion. Pathological vaginal invasion is defined as cervix tumor disruption of the vaginal wall.

Study Sites (1)

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