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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04272190
• Other study ID #: NFEC-2019-105
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: January 1, 2026

Study information

• Verified date: February 2020
• Source: Southern Medical University, China
• Contact: Chen Chunlin, PhD
• Phone: 13725263051
• Email: ccl1[@]smu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: January 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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)

Locations

Country	Name	City	State
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Southern Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	Overall survival was defined as the period from initial treatment until cervical cancer related death.	60 months from primary treatment
Primary	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	Patterns of recurrence	date and localization of 1st recurrence as confirmed histologically	60 months from primary treatment
Secondary	Costs of treatment		60 months from primary treatment
Secondary	Costs of readmission		60 months from primary treatment
Secondary	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
Secondary	The morbidity of sexual dysfunction	Female Sexual Function Index (FSFI)	60 months from primary treatment
Secondary	Intra-operative, peri-operative, post-operative and long term treatment related morbidity	Complications of all the patients	60 months from primary treatment