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

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Progression-free Survival Was Defined From Date of Surgery to Disease Progression Post-surgery or Death or Last Follow-up; Overall Survival Was Defined as Time From Surgery to Death From Any Cause or Last Follow-up

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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Anhui Provincal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Cervical cancer patients seen and treated at the Department of Gynaecological Oncology of the First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
LNM(+); Postoperative pathology suggests lymph node metastasis
LNM(-); Postoperative pathology did not suggest lymph node metastasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
progression-free survival	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	5 years

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital
• Investigators: Study Chair: Yin Zhou, MD, The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression; Death
• Other Study ID Numbers: 2023-KY347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No