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

Southern Medical University

Status: Enrolling

Conditions: Cervical Cancer

Treatments: Other: clinical routine treatments

Study type: Observational

Funder types: Other

Identifiers

NCT04272190

NFEC-2019-105

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically confirmed primary adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, or other histological types carcinoma of the uterine cervix.
2. Patients with Histologically confirmed stage IA1 (with lymph vascular invasion), FIGO 2018 stage IA2 to IIA2.
3. Underwent radical hysterectomy or radiochemotherapy.
4. ECOG Performance Status of 0 or 1.

Exclusion criteria

1. Life expectancy is less than 6 months
2. No prior malignancy
3. ECOG Performance Status of 2 to 5.