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

NCT03738969UNKNOWNOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Lei Li

Enrollment

3000

Start Date

2018-11-10

Completion Date

2022-12-23

Study Type

OBSERVATIONAL

Official Title

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

Interventions

Laparotomic radical hysterectomyLaparoscopic radical hysterectomy

Conditions

Uterine Cervical NeoplasmsLaparotomyLaparoscopySurvivalMortalityRecurrence

Eligibility

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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

Time frame: Five years

Secondary Outcomes

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.

Time frame: 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.

Time frame: Five years

Locations

Lei Li, Beijing, China

Linked Diseases

Uterine Cervical Neoplasms

Uterine Cervical Neoplasms — a type of gynecological cancer.