CCOGELTAMO-COONCT04244331
DETERMINATION OF THE CELL OF ORIGIN (COO) in LDCGB
An observational study of CCO, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 1 site in Spain.
Trial summary
This is a prospective, multicenter study, without any therapeutic intervention that will consist of the analysis of the results of the determination of the COO of all the patients diagnosed with LDCGB in the Spanish hospitals of GELTAMO that adhere to the project. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CCO
- What is being tested?
- CCO
- How many people
- 159 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2018to 1 Mar 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients diagnosed with LDCGB an Age over or equal to 18 years old.
Who may be able to join
- Patients diagnosed with LDCGB in the Spanish GELTAMO sites, without previous treatment and who decide to join the program.
- Age over or equal to 18 years old.
- Having voluntarily given informed consent for the sending and processing of biological samples, as well as for the analysis and reporting of the LDCGB COO results
Who cannot join
- Absence of histological material available to review histology and determine COO
- Patients with LDCGB from any other low-grade lymphoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DETERMINATION OF THE CELL OF ORIGIN (COO) IN PATIENTS DIAGNOSED WITH DIFFUSE LARGE CELL B LYMPHOMA (LDCGB) IN SPANISH HOSPITALS OF GELTAMO GROUP
This is a prospective, multicenter study, without any therapeutic intervention that will consist of the analysis of the results of the determination of the COO of all the patients diagnosed with LDCGB in the Spanish hospitals of GELTAMO that adhere to the project. The determination of the COO will be carried out prospectively at the Genomic Unit of the Hospital Clínic de Barcelona (IDIBAPS), where the histological samples of the patients will be sent for this purpose.
The main study variable will be the description of the COO (germ-center origin [GCB], activated [ABC], NOT DETERMINABLE, NOT VALUABLE)
Read the detailed description
Diffuse large B-cell lymphoma (LDCGB) is the most frequent form of lymphoma in Western countries, accounting for between 30 and 50% of all of them, and represents the paradigm of aggressive lymphoma (1). The current treatment is based on immunochemotherapy, that is, the combination of polychemotherapy (most commonly the CHOP regimen) with an anti-CD20 monoclonal antibody (rituximab). With this therapeutic approach a high proportion of patients are cured, but still 25-35% of them either do not respond to treatment or eventually relapse into the disease (2). New therapies in the experimental phase include other monoclonal antibodies of different specificity and small molecules with a target action.
LDCGB is actually heterogeneous and includes at least two subtypes depending on the cell of origin (COO): those related to a germline center B cell (GCB) and those similar to a post-germline center or activated B cell (ABC). Such groups show important biological, but also clinical and prognostic differences (3). Thus, ABC-type LDCGBs are more aggressive and patients have a worse prognosis. Recent data indicate that COO is also of therapeutic importance: thus, ABC-type LDCGBs would be particularly sensitive to NFkB and certain kinase inhibitors (4). Thus, the determination of COO now basically academic, is going to be a conventional diagnostic procedure in the coming years.
The determination of COO was initially carried out by a gene expression profiling (GEP) technique with frozen material (3). This technique is not realistic in the field of clinical care. Different immunohistochemical algorithms to mimic PEG results in paraffin tissue face great doubts about their reliability and, in fact, cannot be considered conventional (5). More recently, a NanoString technique has been implemented to determine the COO in paraffin tissue with an excellent correlation with PEG results (6). This technique has been used in the context of clinical trials, but no information is available in the general population setting. Precisely the aim of the present project is to apply the NanoString technique to the determination of COO of patients with LDCGB diagnosed during 2018 and 2019 in the Spanish centers associated to the cooperative group GELTAMO.
- Conditions
- CCO
- Being tested
- CCO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCODiagnostic test
Determination of COO in tumor biopsies from patients with GBDD using the Lymph2Cx assay using NanoString tectology
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop Patform
The objective of the study is to develop a platform for the determination of the COO at a national level by means of NanoString in patients diagnosed with LDCGB and to analyze the distribution of this COO.
Measured: 2 years
Secondary outcomes (2)
Integration CCO
To analyze the feasibility of integrating prospective COO determination into clinical care practice.
Measured: 2 years
Determination CCO
To determine the distribution of the COO (GCB, ABC or indeterminate) in the cases included in the LDCGB platform of the Spanish sites.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 May 2018
- Primary completion1 May 2019
- Study completion1 Mar 2020
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CCOStudies 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
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
- Sponsor type
- University, hospital or other
- Collaborators
- Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244331
- Sponsor's protocol ID
- GELTAMO-COO-2017-01
- Acronym
- GELTAMO-COO
- Status last verified
- Jan 2021
- First submitted
- 24 Jan 2020
- Last updated
- 26 Feb 2024
- 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 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DETERMINATION OF THE CELL OF ORIGIN (COO) IN PATIENTS DIAGNOSED WITH DIFFUSE LARGE CELL B LYMPHOMA (LDCGB) IN SPANISH HOSPITALS OF GELTAMO GROUP
- ClinicalTrials.gov ID
- NCT04244331
- Acronym / sponsor ID
- GELTAMO-COO / GELTAMO-COO-2017-01
- Conditions
- CCO
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula ÓseaUniversity, hospital or other
- Collaborators
- Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 28 Jan 2020 (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 is a prospective, multicenter study, without any therapeutic intervention that will consist of the analysis of the results of the determination of the COO of all the patients diagnosed with LDCGB in the Spanish hospitals of GELTAMO that adhere to the project. The determination of the COO will be carried out prospectively at the Genomic Unit of the Hospital Clínic de Barcelona (IDIBAPS), where the histological samples of the patients will be sent for this purpose.
The main study variable will be the description of the COO (germ-center origin [GCB], activated [ABC], NOT DETERMINABLE, NOT VALUABLE)
Detailed description
Diffuse large B-cell lymphoma (LDCGB) is the most frequent form of lymphoma in Western countries, accounting for between 30 and 50% of all of them, and represents the paradigm of aggressive lymphoma (1). The current treatment is based on immunochemotherapy, that is, the combination of polychemotherapy (most commonly the CHOP regimen) with an anti-CD20 monoclonal antibody (rituximab). With this therapeutic approach a high proportion of patients are cured, but still 25-35% of them either do not respond to treatment or eventually relapse into the disease (2). New therapies in the experimental phase include other monoclonal antibodies of different specificity and small molecules with a target action.
LDCGB is actually heterogeneous and includes at least two subtypes depending on the cell of origin (COO): those related to a germline center B cell (GCB) and those similar to a post-germline center or activated B cell (ABC). Such groups show important biological, but also clinical and prognostic differences (3). Thus, ABC-type LDCGBs are more aggressive and patients have a worse prognosis. Recent data indicate that COO is also of therapeutic importance: thus, ABC-type LDCGBs would be particularly sensitive to NFkB and certain kinase inhibitors (4). Thus, the determination of COO now basically academic, is going to be a conventional diagnostic procedure in the coming years.
The determination of COO was initially carried out by a gene expression profiling (GEP) technique with frozen material (3). This technique is not realistic in the field of clinical care. Different immunohistochemical algorithms to mimic PEG results in paraffin tissue face great doubts about their reliability and, in fact, cannot be considered conventional (5). More recently, a NanoString technique has been implemented to determine the COO in paraffin tissue with an excellent correlation with PEG results (6). This technique has been used in the context of clinical trials, but no information is available in the general population setting. Precisely the aim of the present project is to apply the NanoString technique to the determination of COO of patients with LDCGB diagnosed during 2018 and 2019 in the Spanish centers associated to the cooperative group GELTAMO.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with LDCGB an Age over or equal to 18 years old.
Key inclusion criteria (3 listed)
- Patients diagnosed with LDCGB in the Spanish GELTAMO sites, without previous treatment and who decide to join the program.
- Age over or equal to 18 years old.
- Having voluntarily given informed consent for the sending and processing of biological samples, as well as for the analysis and reporting of the LDCGB COO results
Key exclusion criteria (2 listed)
- Absence of histological material available to review histology and determine COO
- Patients with LDCGB from any other low-grade lymphoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCODetermination of COO in tumor biopsies from patients with GBDD using the Lymph2Cx assay using NanoString tectology | Diagnostic test | – |
Primary outcome
Develop Patform
Time frame: 2 years
The objective of the study is to develop a platform for the determination of the COO at a national level by means of NanoString in patients diagnosed with LDCGB and to analyze the distribution of this COO.
2 secondary outcomes
Integration CCO
Time frame: 2 years
Determination CCO
Time frame: 15 days
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- 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.
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 CCO, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 1 site in Spain.
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: stopped early, as of the sponsor's last update on 26 Feb 2024. 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 Spain. 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 was stopped early (reason given: Low recruitment). Results are not available in the source record.
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?
Develop Patform (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 26 Feb 2024.