Effect of Different Treatments on the Prognosis of Early Cervical Cancer: A Multicenter, Prospective, Real-world Study

Study Overview
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Brief Summary
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To observe the effects of different treatments on the oncological outcome and complications of early cervical cancer (2018 FIGO stage IA1 with lymphovascular space invasion and IA2-IIA2 cervical cancer). This study prospectively collecting enrolled cervical cancer patients clinical data and outcome from June 2020 to June 2025. (Classification factors: preoperative neoadjuvant treatment , surgical approach, type of hysterectomy, whether to receive radiochemotherapy) . This study is an observational study, and segmented analysis according to different treatment methods.

Detailed Description
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Objectives: To observe the effects of different treatments on the oncological outcome and complications of early cervical cancer (2018 FIGO stage IA1 with lymphovascular space invasion and IA2-IIA2 cervical cancer). Study Design: We obtained the demographic, clinical, treatment hospital and complication data of patients with cervical cancer undergoing radical hysterectomy from 2004 to 2015 at 37 hospitals. The patients were assigned into groups. Classification factors: preoperative neoadjuvant treatment (not received, neoadjuvant chemotherapy, preoperative radiotherapy) , surgical approach (abdomincal, laparoscopic, vaginal, robotic surgery), type of hysterectomy (type B, type C1, type C2), primary treatment (radiochemotherapy or surgery). laparoscopic and abdominal surgery groups. The differences in the survival, complication rates, quality of life, and cost were analyzed using univariate and multivariable logistic regression models.

Official Title
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Effect of Different Treatments on the Prognosis of Early Cervical Cancer: A Multicenter, Prospective, Real-world Study

Conditions
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Cervical Cancer

Intervention / Treatment
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* Other: clinical routine treatments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed primary adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, or other histological types carcinoma of the uterine cervix. Patients with Histologically confirmed stage IA1 (with lymph vascular invasion), FIGO 2018 stage IA2 to IIA2. Underwent radical hysterectomy or radiochemotherapy. ECOG Performance Status of 0 or 1. Exclusion Criteria: Life expectancy is less than 6 months No prior malignancy ECOG Performance Status of 2 to 5.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: clinical routine treatments|The cohort stratified by four factors: preoperative treatment (not received, neoadjuvant chemotherapy, preoperative radiotherapy); surgical approach (laparoscopic, abdominal, vaginal, robotic); hysterectomy types (type A, type B, type C1, type C2), primary treatment (Radical hysterectomy + pelvic lymph node dissectionp; radiochemotherapy)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | Overall survival was defined as the period from initial treatment until cervical cancer related death. | 60 months from primary treatment | 
| disease-free survival (DFS) | Tumor-free survival was defined as the period from initial treatment until the recurrence or the date of last follow-up. | 60 months from primary treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patterns of recurrence | date and localization of 1st recurrence as confirmed histologically | 60 months from primary treatment | 
| Costs of treatment |  | 60 months from primary treatment | 
| Costs of readmission |  | 60 months from primary treatment | 
| Quality of life Questionnaires | The European O-rganization for Reasearch and Treatment of Cance QLQ-30 Questionnaires to measure quality of life for any kind cancer patient. The Europe Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Cervical Cancer Module is a supplementary questionnaire for evaluating the quality of life of patients with cervical cancer. | 60 months from primary treatment | 
| The morbidity of sexual dysfunction | Female Sexual Function Index (FSFI) | 60 months from primary treatment | 
| Intra-operative, peri-operative, post-operative and long term treatment related morbidity | Complications of all the patients | 60 months from primary treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical cancer, Preoperative treatment, Surgical approach, Hysterectomy type, Radiochemotherapy