Diffuse Large B-Cell LymphomaNCT02708732
Utility Study in Diffuse Large B-Cell Lymphoma (DLBCL)
An observational study of Diffuse Large B-Cell Lymphoma, run by Hoffmann-La Roche at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- How many people
- 91 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 May 2016to 31 Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- Adults greater than or equal to (>/=) 18 years of age
- Diagnosis of DLBCL and currently in first remission
- Prior drug treatment for DLBCL
Who cannot join
- Receiving active treatment for DLBCL
- Relapsed following any treatment for DLBCL
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
PH Associates - an OPen Health Company
Marlow, SL7 2FF
About this study
Official title: UK Utility Study in Diffuse Large B-Cell Lymphoma
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.
- Conditions
- Diffuse Large B-Cell Lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DLBCL Participants | A cohort of approximately 100 patients in first remission with DLBCL will complete questionnaires through a 15-minute postal or online survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related Quality of Life According to European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Score
Measured: Up to 4 months of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study start31 May 2016
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708732
- Sponsor's protocol ID
- ML29956
- Status last verified
- Apr 2017
- First submitted
- 10 Mar 2016
- Last updated
- 20 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UK Utility Study in Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT02708732
- Acronym / sponsor ID
- ML29956
- Conditions
- Diffuse Large B-Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 31 May 2016 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DLBCL Participants | – | –A cohort of approximately 100 patients in first remission with DLBCL will complete questionnaires through a 15-minute postal or online survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (3 listed)
- Adults greater than or equal to (>/=) 18 years of age
- Diagnosis of DLBCL and currently in first remission
- Prior drug treatment for DLBCL
Key exclusion criteria (2 listed)
- Receiving active treatment for DLBCL
- Relapsed following any treatment for DLBCL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health-Related Quality of Life According to European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Score
Time frame: Up to 4 months of data collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B-Cell Lymphoma, run by Hoffmann-La Roche at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Quality of Life According to European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Score (time frame: Up to 4 months of data collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.