Effect of Different Treatments on the Prognosis of Early Cervical Cancer: A Multicenter, Prospective, Real-world Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 IIA
- •Underwent radical hysterectomy or radiochemotherapy.
- •ECOG Performance Status of 0 or 1.
排除标准
- •Life expectancy is less than 6 months
- •No prior malignancy
- •ECOG Performance Status of 2 to 5.
结局指标
主要结局
Overall survival (OS)
时间窗: 60 months from primary treatment
Overall survival was defined as the period from initial treatment until cervical cancer related death.
disease-free survival (DFS)
时间窗: 60 months from primary treatment
Tumor-free survival was defined as the period from initial treatment until the recurrence or the date of last follow-up.
次要结局
- Patterns of recurrence(60 months from primary treatment)
- Costs of readmission(60 months from primary treatment)
- Quality of life Questionnaires(60 months from primary treatment)
- The morbidity of sexual dysfunction(60 months from primary treatment)
- Intra-operative, peri-operative, post-operative and long term treatment related morbidity(60 months from primary treatment)
- Costs of treatment(60 months from primary treatment)
研究者
Chen Chunlin
Director of Department of Obstetrics and Gynecology
Southern Medical University, China