Longitudinal Study of Different Surgical Approaches in Chinese Patients of Uterine Cervical Cancer

Longitudinal Study of Different Surgical Approaches in Chinese Patients of Cervical Cancer

This multi-center longitudinal study aims to compare the survival outcomes (including overall survival, progression-free survival and disease-free survival between uterine cervical patients receiving different surgical routes (vaginal, laparotomy and laparoscopy), which is the primary study objective. All clinical and pathological data would be retracted from case reviews, and all survival data would be reached by clinic, telephone and mail follow-up. This study also would analyze the impact on survival outcomes of other factors, including nerve-sparing techniques, neoadjuvant chemotherapy, neoadjuvant radiotherapy and infection of human papillomavirus. The predictive effects of different following protocol and imaging plans will be also compared. Last, the influences of surgical routes on the fertility outcomes (pregnancy and its complications) and the ovarian reserve are important secondary study objectives.

Study Overview

• Status: Recruiting
• Conditions: Recurrence; Uterine Cervical Neoplasms; Mortality; Laparotomy; Laparoscopy; Survival
• Intervention / Treatment: Procedure: Laparotomic radical hysterectomy; Procedure: Laparoscopic radical hysterectomy

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Lei Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All patients pathological confirmed as uterine cervival cancer and receiving radical hysterectomy or trachelectomy would been included.

Description

Inclusion Criteria:

• Pathological confirmed as uterine cervical cancer
• Having definite clinical information
• Having received radical hysterectomy or trachelectomy

Exclusion Criteria:

• Not satisfying any of the inclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Laparotomy group; Patients in this group accepted laparotomic radical hysterectomy for cervical cancer.	Procedure: Laparotomic radical hysterectomy; Radical hysterectomy applied by laparotomy
Laparoscopy group; Patients in this group accepted laparoscopic or robotic radical hysterectomy for cervical cancer.	Procedure: Laparoscopic radical hysterectomy; Radical hysterectomy applied by laparoscopic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Length of time during and after the treatment of cervical cancer, that a patient lives with the disease but it does not get worse	Five years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. In a clinical trial, measuring the overall survival is one way to see how well a new treatment works.	Five years
Disease-free survival	In cancer, the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works.	Five years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy rate	Proportion of patients who have been pregnant after the fertility-preserving radical trachelectomy	Five years

Collaborators and Investigators

• Sponsor: Lei Li

Publications and helpful links

General Publications

• Chao X, Wu M, Ma S, Tan X, Zhong S, Song X, Li L. Efficacy of different surgical approaches on survival outcomes in patients with early-stage cervical cancer: protocol for a multicentre longitudinal study in China. BMJ Open. 2020 Aug 20;10(8):e038020. doi: 10.1136/bmjopen-2020-038020.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2018
• Primary Completion (Anticipated): December 23, 2022
• Study Completion (Anticipated): December 23, 2023

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 8, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 9, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Disease Attributes; Uterine Cervical Neoplasms; Recurrence
• Other Study ID Numbers: SACCC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All the data will be available to all researchers on the public websites
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

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