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

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer
• Intervention / Treatment: Other: clinical routine treatments

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 20000

Contacts and Locations

• Study Contact: Name: Chen Chunlin, PhD; Phone Number: 13725263051; Email: ccl1@smu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital of Southern Medical University
      • Contact: Li Wenyuan, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Cervical cancer patients

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Southern Medical University, China
• Investigators: Principal Investigator: Chen Chunlin, PhD, Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2020
• Primary Completion (ANTICIPATED): June 1, 2025
• Study Completion (ANTICIPATED): January 1, 2026

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (ACTUAL): February 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 14, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Cervical cancer; Radiochemotherapy; Preoperative treatment; Surgical approach; Hysterectomy type
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: NFEC-2019-105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No