A Diagnostic Nomogram for Predicting Vaginal Invasion in Cervical Cancer

Not yet recruiting

• Conditions: Cervix Carcinoma
• Interventions: Other: no intervention

• Registration Number: NCT06039982
• Lead Sponsor: Fujian Cancer Hospital

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.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-11
• Study First Submitted QC: 2023-09-11
• Study First Posted: 2023-09-15
• Last Update Submitted: 2023-09-23
• Last Update Posted: 2023-09-26
• Study Start: 2023-11-01
• Primary Completion: 2026-11-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cervical cancer treated with surgery	no intervention	The inclusion criteria were: (1) pathologically confirmed CC; (2) FIGO stage IB-IIA according to the result of physical examination and imaging; (3) abdominal MRI was performed within three weeks before surgery. Exclusion criteria were: (1) accompanied with other tumors. (2) with chronic infectious disease. (3) incomplete clinical data.

Primary Outcome Measures

Name	Time	Method
vaginal invasion	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.

Trial Locations

Locations (1)

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China