Clinical trial NCT06480617: Observational, Bivariate Analysis of Clinical Big Data in Patients With Cervical Cancer
Official title: The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Study type: OBSERVATIONAL
Overall 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
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2024-06-28
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: progression-free survival
timeFrame: 5 years
Secondary outcomes:
measure: overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincal Hospital
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
name: Yin Zhou, MD
role: STUDY_CHAIR
References: