Survival Outcomes of Uterine Malignancies in Chinese Popu... | NCT03291275

Studies
Survival Outcomes of Uterine Malignancies in Chinese Population

NCT03291275

Sponsor

Lei Li

Status

Unknown status

Last Update Posted

Feb 8, 2018Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Endometrial Neoplasms
Survival

Interventions

Follow-up for death and recurrence

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Sep 1, 2022Estimated

Completion Date

Sep 1, 2023Estimated

First Submitted Date

Sep 20, 2017

First Submission Date that Met QC Criteria

Sep 20, 2017

First Posted Date

Sep 25, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2018

Last Update Posted Date

Feb 8, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Follow-up for death and recurrence	Other	All patients are followed up to determine definite date of diagnosis, recurrence and death.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	Survival duration from diagnosis to death	5 years
Progression-free survival	Survival duration from last treatment after remission to recurrence	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary uterine malignancies.

Exclusion Criteria:

Metastatic malignancies to uterine corpus

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients with definite diagnosis of uterine malignancies in China.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lei Li, MD	Contact	13911988831	+86	lileigh@163.com

Overall Officials

Name	Affiliation	Role
Lei Li, MD	Peking Union Medical College Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lei Li	Recruiting	Beijing	China/Beiing	100000	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29941707	Derived	Li L, Ma SQ, Tan XJ, Zhong S, Wu M. Pelvic Exenteration for Recurrent and Persistent Cervical Cancer. Chin Med J (Engl). 2018 Jul 5;131(13):1541-1548. doi: 10.4103/0366-6999.235111.

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

ID	Term
D000071458	Death Domain Superfamily
D054730	Protein Interaction Domains and Motifs
D000072417	Protein Domains
D000072416	Protein Structural Elements