NCT03738969

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

November 10, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2023

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

4.1 years

First QC Date

November 8, 2018

Last Update Submit

November 9, 2018

Conditions

Uterine Cervical NeoplasmsLaparotomyLaparoscopySurvivalMortalityRecurrence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Overall survival

    Five years

  • Disease-free survival

    Five years

Other Outcomes (1)

  • Pregnancy rate

    Five years

Study Arms (2)

Laparotomy group

Patients in this group accepted laparotomic radical hysterectomy for cervical cancer.

Procedure: Laparotomic radical hysterectomy

Laparoscopy group

Patients in this group accepted laparoscopic or robotic radical hysterectomy for cervical cancer.

Procedure: Laparoscopic radical hysterectomy

Interventions

Laparotomic radical hysterectomyPROCEDURE

Radical hysterectomy applied by laparotomy

Laparotomy group
Laparoscopic radical hysterectomyPROCEDURE

Radical hysterectomy applied by laparoscopic

Laparoscopy group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32819996DERIVED

MeSH Terms

Conditions

Uterine Cervical NeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Lei Li, M.D.

CONTACT

13911988831lileigh@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 8, 2018

First Posted

November 13, 2018

Study Start

November 10, 2018

Primary Completion

December 23, 2022

Study Completion

December 23, 2023

Last Updated

November 14, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will share

All the data will be available to all researchers on the public websites

Shared Documents
STUDY PROTOCOL, CSR

Locations

CN(1)