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Clinical Trials/NCT03738969
NCT03738969
Unknown
Not Applicable

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

Lei Li1 site in 1 country3,000 target enrollmentNovember 10, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Uterine Cervical Neoplasms
Sponsor
Lei Li
Enrollment
3000
Locations
1
Primary Endpoint
Progression-free survival
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 10, 2018
End Date
December 23, 2023
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Lei Li
Responsible Party
Sponsor Investigator
Principal Investigator

Lei Li

Professor

Peking Union Medical College Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Progression-free survival

Time Frame: Five years

Length of time during and after the treatment of cervical cancer, that a patient lives with the disease but it does not get worse

Secondary Outcomes

  • Overall survival(Five years)
  • Disease-free survival(Five years)

Study Sites (1)

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