Observational, Bivariate Analysis of Clinical Big Data in Patients With Cervical Cancer

Active, not recruiting

• Conditions: Overall Survival Was Defined as Time From Surgery to Death From Any Cause or Last Follow-up; Progression-free Survival Was Defined From Date of Surgery to Disease Progression Post-surgery or Death or Last Follow-up

• Registration Number: NCT06480617
• Lead Sponsor: Anhui Provincial Hospital

Brief Summary

This is a large non-interventional observational bidirectional study planned to collect clinically relevant data and prognostic follow-up information of patients with cervical cancer who were seen at our center from 2010.01.01 to the end of this study.

Detailed Description

This study is a large-scale observational, bi-directional analytical study, which collects clinical data from patients with cervical cancer who have received treatment in the Department of Gynecologic Oncology of the First Hospital Affiliated to the University of Science and Technology of China (Anhui Provincial Hospital), including age, weight, BMI, menopausal status, history of the current disease, past history, specialized examinations, results of tests, results of genetic testing, pathology-related data, and information related to surgery, etc. The diagnosis, subsequent treatment, and follow-up of the subjects follow the routine clinical procedures of the clinical center. The diagnosis and subsequent treatment and follow-up of the subjects followed the routine clinical procedures of the clinical center, and the follow-up data of the enrolled patients were collected every six months: imaging, tumor markers, recurrence and treatment. And clinical big data analysis. Therefore, patients who meet the enrollment criteria can be included, and the sample size is based on the actual number of cases included.

Study Timeline

• Study Start: 2023-10-31
• Status Verified: 2024-06
• Study First Submitted: 2024-06-25
• Study First Submitted QC: 2024-06-25
• Last Update Submitted: 2024-06-25
• Study First Posted: 2024-06-28
• Last Update Posted: 2024-06-28
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 3000

Inclusion Criteria

1. Age ≥ 18 years;
2. patients with a clear pathological diagnosis of cervical cancer;
3. all patients included in this study were diagnosed after 1 January 2010
4. Diagnosis or treatment of cervical cancer at the centres covered by this study;
5. exemption from informed consent or signing of an informed consent form.

Exclusion Criteria

1. Loss of contact during the follow-up period for no apparent reason;
2. Discharged from the hospital for follow-up treatment at an outside institution with unknown treatment status;
3. The investigator considers the patient unsuitable for participation in this study;
4. cases where the clinical diagnosis is in doubt or unclear.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
progression-free survival	5 years

Secondary Outcome Measures

Name	Time	Method
overall survival	5 years

Trial Locations

Locations (1)

Anhui Provincal Hospital; 🇨🇳 Hefei, Anhui, China