A Multicenter Prospective Study of "High Risk" Molecular... | NCT04320992

Studies
A Multicenter Prospective Study of "High Risk" Molecular Typing in Patients With Adult T Lymphoblastic Lymphoma

NCT04320992

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Mar 26, 2020Actual

Enrollment

207Estimated

Phase

Not provided

Conditions

T-Lymphoblastic Lymphoma/Leukemia

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

Mar 2020

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

Mar 2020Estimated

Primary Completion Date

Mar 2023Estimated

Completion Date

Mar 2023Estimated

First Submitted Date

Mar 23, 2020

First Submission Date that Met QC Criteria

Mar 23, 2020

First Posted Date

Mar 25, 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

Mar 25, 2020

Last Update Posted Date

Mar 26, 2020Actual

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

The purpose of this study is to determine the indicative value of "high risk" molecular typing in patients with adult T lymphoblastic lymphoma

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

207Estimated

Measure	Description	Time Frame
progression free survival		3-years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

biopsy proved T lymphoblastic lymphoma
newly diagnosed patients

Exclusion Criteria:

patients with biopsy samples unavailable

Accepts Healthy Volunteers

Not provided

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

adults

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qing qing Cai, MD	Contact	0086-20-87342823		caiqq@sysucc.org.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,	Recruiting	Guangzhou		51000	China

Condition Browse Module

MeSH Terms

ID	Term
D054218	Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
D007938	Leukemia

Ancestor Terms

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D007945	Leukemia, Lymphoid
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
tested group
controlled group