Prognostic Nomogram of Extranodal NK/T-cell Lymphoma | NCT04554511

Studies
Prognostic Nomogram of Extranodal NK/T-cell Lymphoma

NCT04554511

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Jun 18, 2023Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Extranodal NK/T-cell Lymphoma

Interventions

Not provided

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

Jun 2023

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

Aug 28, 2020Actual

Primary Completion Date

Jan 1, 2024Estimated

Completion Date

Jan 1, 2024Estimated

First Submitted Date

Sep 12, 2020

First Submission Date that Met QC Criteria

Sep 12, 2020

First Posted Date

Sep 18, 2020Actual

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

Jun 15, 2023

Last Update Posted Date

Jun 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 evaluate prognostic factors for overall survival and explore risk progression-free survival in ENKTL, and establish a prognostic predictive nomogram for ENKTL patients.

Detailed Description

This is a retrospective cohort study using anonymized information from patients with ENKTL. The following criteria are required: (1) Patients diagnosed with ENKTL between January 1, 2000 and August 31, 2020; (2) Patients older than 18 years. The pathology of initial diagnosis was reviewed by designated pathologists.

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

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Training cohort		Patients diagnosed with ENKTL, between January 1, 2000 and August 31, 2020.
Validation Cohort		Patients diagnosed with ENKTL, between January 1, 2000 and August 31, 2020.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	Time between the date of diagnosis and any kinds of death	5 year

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival	Time between the date of diagnosis and any kinds of death or relapse/progression	5 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients newly diagnosed with ENKTL
Patients diagnosed between January 1, 2000 and August 31, 2020
Patients older than 18 years

Exclusion Criteria:

Patients who did not have complete clinical information or immunohistochemistry, or who were lost follow-up immediately after treatment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients diagnosed with ENKTL, between January 1, 2000 and August 31, 2020;
Patients older than 18 years.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hua Wang	Contact	+862087342462		wanghua@sysucc.org.cn

Overall Officials

Name	Affiliation	Role
Hua Wang	Sun Yat-sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-sen University Cancer Center	Recruiting	Guangzhou	Guangdong	510060	China

Condition Browse Module

MeSH Terms

ID	Term
D054391	Lymphoma, Extranodal NK-T-Cell

Ancestor Terms

ID	Term
D016399	Lymphoma, T-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided