Lymphoma, Large B-cell, DiffuseNCT03211702
Geriatric Assessments in Elderly Diffuse Large B-cell Lymphoma Patients-2 (GERIAD2)
An observational study of Lymphoma, Large B-cell, Diffuse, run by Chonbuk National University Hospital at 2 sites in South Korea.
Trial summary
This study will validate the impact of comprehensive geriatric assessments using activity of daily living (ADL), instrumental activity of daily living (IADL), and Charlson's comorbidity index (CCI) on survival and toxicities in Korean patients with diffuse large B-cell lymphoma (DLBCL) treated with R-CHOP. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Lymphoma, Large B-cell, Diffuse
- How many people
- 100 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 25 Aug 2017to 30 Dec 2020
- 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 65 years and older
- All sexes
- Older adult
Study population: Elderly DLBCL patients (≥ 65 years) treated with R-CHOP
Who may be able to join
- Patients with newly diagnosed CD20+ DLBCL
- 65 years old or over
- Scheduled to receive R-CHOP chemotherapy
- Informed consent
Who cannot join
- Other histology than CD20+ DLBCL
- Primary central nervous system DLBCL
- Patients with a diagnosis of cancer (other than basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, well differentiated thyroid cancer [papillary or follicular thyroid cancer]) within 3 years before the study entry or with any treatment for cancer within 3 years before entry
- Consent withdrawal
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Chonnam National University Hwasun Hospital
Hwasun
Chonbuk National University Hospital
Jeonju, 561-712
About this study
Official title: Multi-center, Prospective Cohort Study-II to Investigate the Impact of Comprehensive Geriatric Assessments on Survival and Toxicities in Elderly Diffuse Large B-cell Lymphoma Patients Treated With R-CHOP (GERIAD2)
This study will validate the impact of comprehensive geriatric assessments using activity of daily living (ADL), instrumental activity of daily living (IADL), and Charlson's comorbidity index (CCI) on survival and toxicities in Korean patients with diffuse large B-cell lymphoma (DLBCL) treated with R-CHOP.
- Conditions
- Lymphoma, Large B-cell, Diffuse
- Keywords
- geriatric assessments, diffuse large B-cell lymphoma, activity of daily living, instrumental activity of daily living, Charlson's comorbidity index
- 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 |
|---|---|---|
| Elderly DLBCL patients | Elderly DLBCL patients (age>=65 years) treated with R-CHOP chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Event-free survival was defined as death, relapse from complete remission, progression during or after treatment, and discontinuation or changes of therapy during treatments
Measured: 2 years
Secondary outcomes (3)
Overall survival
Measured: 5 years
Progression-free survival
Measured: 5 years
Cumulative incidence of grade 3/4 adverse events and premature treatment discontinuation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start25 Aug 2017
- Primary completion30 Apr 2018
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Large B-cell, DiffuseStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Catholic University of Korea, Kyungpook National University Hospital, Keimyung University Dongsan Medical Center, Korea University Anam Hospital, Korea University Guro Hospital, Kosin University Gospel Hospital, Pusan National University Hospital, Soonchunhyang University Hospital, Ajou University School of Medicine, Chonnam National University Hospital, Chungnam National University Hospital, Yeungnam University Hospital
- Responsible party
- Principal investigator, Ho-Young Yhim, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211702
- Sponsor's protocol ID
- GERIAD2
- Status last verified
- Feb 2023
- First submitted
- 6 Jul 2017
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Prospective Cohort Study-II to Investigate the Impact of Comprehensive Geriatric Assessments on Survival and Toxicities in Elderly Diffuse Large B-cell Lymphoma Patients Treated With R-CHOP (GERIAD2)
- ClinicalTrials.gov ID
- NCT03211702
- Acronym / sponsor ID
- GERIAD2
- Conditions
- Lymphoma, Large B-cell, Diffuse
- Keywords
- geriatric assessments, diffuse large B-cell lymphoma, activity of daily living, instrumental activity of daily living, Charlson's comorbidity index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Collaborators
- The Catholic University of Korea, Kyungpook National University Hospital, Keimyung University Dongsan Medical Center, Korea University Anam Hospital, Korea University Guro Hospital, Kosin University Gospel Hospital, Pusan National University Hospital, Soonchunhyang University Hospital, Ajou University School of Medicine, Chonnam National University Hospital, Chungnam National University Hospital, Yeungnam University Hospital
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 7 Jul 2017 (actual)
- 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 will validate the impact of comprehensive geriatric assessments using activity of daily living (ADL), instrumental activity of daily living (IADL), and Charlson's comorbidity index (CCI) on survival and toxicities in Korean patients with diffuse large B-cell lymphoma (DLBCL) treated with R-CHOP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly DLBCL patients | – | –Elderly DLBCL patients (age>=65 years) treated with R-CHOP chemotherapy |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Elderly DLBCL patients (≥ 65 years) treated with R-CHOP
Key inclusion criteria (4 listed)
- Patients with newly diagnosed CD20+ DLBCL
- 65 years old or over
- Scheduled to receive R-CHOP chemotherapy
- Informed consent
Key exclusion criteria (4 listed)
- Other histology than CD20+ DLBCL
- Primary central nervous system DLBCL
- Patients with a diagnosis of cancer (other than basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, well differentiated thyroid cancer [papillary or follicular thyroid cancer]) within 3 years before the study entry or with any treatment for cancer within 3 years before entry
- Consent withdrawal
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
Event-free survival
Time frame: 2 years
Event-free survival was defined as death, relapse from complete remission, progression during or after treatment, and discontinuation or changes of therapy during treatments
3 secondary outcomes
Overall survival
Time frame: 5 years
Progression-free survival
Time frame: 5 years
Cumulative incidence of grade 3/4 adverse events and premature treatment discontinuation
Time frame: 1 year
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 3 Feb 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, Large B-cell, Diffuse, run by Chonbuk National University Hospital at 2 sites in South Korea.
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 4 inclusion and 4 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 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
Event-free survival (time frame: 2 years). 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 3 Feb 2023.