Utility Study in Diffuse Large B-Cell Lymphoma (DLBCL) | NCT02708732

Studies
Utility Study in Diffuse Large B-Cell Lymphoma (DLBCL)

NCT02708732

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Apr 20, 2017Actual

Enrollment

91Actual

Phase

Not provided

Conditions

Diffuse Large B-Cell Lymphoma

Interventions

Not provided

Countries

United Kingdom

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

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 31, 2016Actual

Primary Completion Date

Oct 31, 2016Actual

Completion Date

Oct 31, 2016Actual

First Submitted Date

Mar 10, 2016

First Submission Date that Met QC Criteria

Mar 10, 2016

First Posted Date

Mar 15, 2016Estimated

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

Apr 19, 2017

Last Update Posted Date

Apr 20, 2017Actual

Description Module

Brief Summary

This study is a prospective, cross-sectional survey to be administered to real patients in remission from DLBCL using a 15-minute postal or online survey. The project is designed to describe the impact of DLBCL remission on health utility and quality of life. Data collection will occur over a 4-month period.

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

91Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DLBCL Participants		A cohort of approximately 100 patients in first remission with DLBCL will complete questionnaires through a 15-minute postal or online survey.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Health-Related Quality of Life According to European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Score		Up to 4 months of data collection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults greater than or equal to (>/=) 18 years of age
Diagnosis of DLBCL and currently in first remission
Prior drug treatment for DLBCL

Exclusion Criteria:

Receiving active treatment for DLBCL
Relapsed following any treatment for DLBCL

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

Approximately 100 patients in first remission with DLBCL will be recruited from online advertisements and a specialist medical recruitment agency to complete study-administered questionnaires.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PH Associates - an OPen Health Company		Marlow		SL7 2FF	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D016403	Lymphoma, Large B-Cell, Diffuse

Ancestor Terms

ID	Term
D016393	Lymphoma, B-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided