NCT03291236

Brief Summary

This study aims to determine survival outcomes (overall survival and progression-free survival) of primary malignancies of uterine cervix in China and relevant risk factors in a prospective cohort study.

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
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

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

Study Start

First participant enrolled

January 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

February 8, 2018

Status Verified

February 1, 2018

Enrollment Period

5 years

First QC Date

September 20, 2017

Last Update Submit

February 7, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Overall survival

    Duration from diagnosis to recurrence

    5 years

  • Progression-free survival

    Duration from last treatment after remission to recurrence

    5 years

Interventions

All patients are follow-up to determine specific date of diagnosis, recurrence and death.

Eligibility Criteria

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

All patients with primary malignancies of uterine cervix in China.

You may qualify if:

  • Primary malignancies of uterine cervix.

You may not qualify if:

  • Secondary malignancies of uternie cervix.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lei Li

Beijing, China/Beiing, 100000, China

RECRUITING

Related Publications (1)

  • Li L, Ma S, Tan X, Zhong S, Wu M. The Urodynamics and Survival Outcomes of Different Methods of Dissecting the Inferior Hypogastric Plexus in Laparoscopic Nerve-Sparing Radical Hysterectomy of Type C: A Randomized Controlled Study. Ann Surg Oncol. 2019 May;26(5):1560-1568. doi: 10.1245/s10434-019-07228-8. Epub 2019 Feb 13.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Death Domain

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Death Domain SuperfamilyProtein Interaction Domains and MotifsProtein DomainsProtein Structural ElementsProtein ConformationMolecular ConformationMolecular StructureBiochemical PhenomenaChemical Phenomena

Study Officials

  • Lei Li, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

September 20, 2017

First Posted

September 25, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

February 8, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations