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

Recurrence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03738969
• Other study ID #: SACCC
• Status: Recruiting
• Start date: November 10, 2018
• Est. completion date: December 23, 2023

Study information

• Verified date: November 2018
• Source: Peking Union Medical College Hospital
• Contact: Lei Li, M.D.
• Phone: 13911988831
• Email: lileigh[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 23, 2023
• Est. primary completion date: December 23, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopy
• Laparotomy
• Mortality
• Recurrence
• Survival
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Laparotomic radical hysterectomy
Radical hysterectomy applied by laparotomy
• Laparoscopic radical hysterectomy
Radical hysterectomy applied by laparoscopic

Locations

Country	Name	City	State
China	Lei Li	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pregnancy rate	Proportion of patients who have been pregnant after the fertility-preserving radical trachelectomy	Five years
Primary	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	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
Secondary	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