Lymphoma, T-Cell, PeripheralNCT02788916
A Retrospective Study of Clinical, Phenotypic and Genetic Factors of Peripheral T-Cell Lymphomas
An observational study of Lymphoma, T-Cell, Peripheral, run by Takeda at 10 sites in Spain.
Trial summary
The purpose of this study is to establish the distribution of peripheral T-cell lymphocyte (PTCL) subtypes by re-analysis and re-classification of samples according to the 2008 World Health Organization (WHO) classification of lymphoid neoplasms. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphoma, T-Cell, Peripheral
- How many people
- 198 participants
- Where
- 10 sitesSpain
- Study dates
- 25 Sep 2015to 12 Jan 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants diagnosed with PTCL in the six years between 01 January 2008 and 31 December 2013 in the participating sites.
Who may be able to join
- Participants diagnosed with PTCL in the six years between 01/01/2008 and 31/12/2013.
- Availability of initial tumor biopsy diagnosis in paraffin block (node or core biopsy of 16-18mm).
- PTCL subtypes permitted by WHO 2008 classification of lymphoid neoplasms:
- Natural killer/ T-lymphocytes (NK /T-cell) lymphoma extranodal nasal type
- Enteropathic T-cell lymphoma
- Hepatosplenic T-cell lymphoma
Show all 10Show fewer
- Peripheral T-cell lymphoma, not otherwise specified
- Angioimmunoblastic T-cell lymphoma
- Anaplastic large cell lymphoma, Anaplastic lymphoma kinase positive (ALK)+
- Anaplastic large cell lymphoma, ALK-
Who cannot join
- Participants with an unavailable history (lost, empty or not recoverable).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Study site
Barcelona, Barcelona
Study site
Córdoba, Cordoba
Study site
Madrid, Madrid
Study site
Majadahonda, Madrid
Study site
Oviedo, Oviedo
Study site
Salamanca, Salamanca
Study site
Santander, Cantabria
Study site
Santiago de Compostela, A Coruna
Study site
Seville, Sevilla
Study site
Valencia, Valencia
About this study
Official title: A Retrospective Study of Clinical, Phenotypic and Genetic Factors of Peripheral T-Cell Lymphomas in the Spanish Population
The purpose of this study is to establish the distribution of peripheral T-cell lymphocyte (PTCL) subtypes by re-analysis and re-classification of samples according to the 2008 World Health Organization (WHO) classification of lymphoid neoplasms.
Read the detailed description
This study is a retrospective, non-interventional and, post-authorization observational study of other designs (PAS-OD).
This multicenter trial will be conducted in Spain. Retrospective review of medical records and initial tumor biopsies of participants diagnosed with PTCL in the period of 6 years between 01/01/2008 and 31/12/2013 will be performed. Initial tumor biopsies and histological preparations, filed and previously anonymized, will be sent to the central laboratory for assessment.
- Conditions
- Lymphoma, T-Cell, Peripheral
- Being tested
- No Intervention
- Keywords
- Drug Therapy
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Assessment of tumor biopsies and histological preparations of participants diagnosed with peripheral T-cell lymphoma (PTCL) in the six years between 01 January 2008 and 31 December 2013 will be performed. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of Peripheral T-cell Lymphoma (PTCL) Subtypes
Distribution of PTCL subtypes by re-analysis and re-classification of samples according to the 2008 WHO classification of lymphoid neoplasms will be estimated.
Measured: Up to 6 months
Secondary outcomes (8)
Percentage of Participants with Each Subtypes of PTCL
Percentage of participants with each subtypes of PTCL according to the WHO 2008 classification of lymphoid neoplasms will be reported.
Measured: Up to 6 months
Rate of Discrepancy Between the Initial Diagnosis and Re-analysis and Re-classification
Rate of discrepancy between the initial diagnosis of PTCL in participants and diagnosis by re-analysis and re-classification according to the WHO 2008 classification will be determined.
Measured: Up to 6 months
Expression of Cluster of Differentiation 30 (CD30) by Immunohistochemistry and Quantitative Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) in Different Subtypes of PTCL
Expression of CD30 by immunohistochemistry and quantitative RT-PCR in different subtypes of PTCL will be determined.
Measured: Up to 6 months
Correlation Between the Expression of CD30 and Lymphoid Lineage
Markers of T and B cells will be used in order to determine if CD30 expression occurs in tumor cells or other B-lineage.
Measured: Up to 6 months
Correlation Between the Expression of CD30, Prognostic Indices Used In PTCL and Survival
Survival includes progression free survival: period from date of start of treatment until tumor progression or death, whichever occurs first. Overall survival: period from date of diagnosis to the date of death.
Measured: Up to 6 months
Classification of Peripheral T-cell Lymphoma
The PTCL is classified according to the expression of CD30 and T-Cell Receptor ß (TCRß) and T-Cell Receptor γ (TCRγ) by immunohistochemistry (IHC).
Measured: Up to 6 months
T-cell Clonality in PTCL
Analysis of T-cell clonality in PTCL will be performed. Clonality defines the profile of gene rearrangement of T cell receptor and allow establishing whether proliferation is monoclonal.
Measured: Up to 6 months
Correlation Between Most frequent Mutations and Clinical, Phenotypic Factors
Distribution of the most frequent mutations in tumors and its correlation with clinical and phenotypic factors will be determined.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study start25 Sep 2015
- Primary completion10 Nov 2016
- Study completion12 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, T-Cell, PeripheralStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Retrospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788916
- Sponsor's protocol ID
- Brentuximab-5012
- Other IDs
- TAK-HEM-2015-01
- Status last verified
- Mar 2017
- First submitted
- 23 May 2016
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of Clinical, Phenotypic and Genetic Factors of Peripheral T-Cell Lymphomas in the Spanish Population
- ClinicalTrials.gov ID
- NCT02788916
- Acronym / sponsor ID
- Brentuximab-5012
- Conditions
- Lymphoma, T-Cell, Peripheral
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2015 (actual)
- Primary completion
- 10 Nov 2016 (actual)
- Study completion
- 12 Jan 2017 (actual)
- First posted
- 2 Jun 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.
The purpose of this study is to establish the distribution of peripheral T-cell lymphocyte (PTCL) subtypes by re-analysis and re-classification of samples according to the 2008 World Health Organization (WHO) classification of lymphoid neoplasms.
Detailed description
This study is a retrospective, non-interventional and, post-authorization observational study of other designs (PAS-OD).
This multicenter trial will be conducted in Spain. Retrospective review of medical records and initial tumor biopsies of participants diagnosed with PTCL in the period of 6 years between 01/01/2008 and 31/12/2013 will be performed. Initial tumor biopsies and histological preparations, filed and previously anonymized, will be sent to the central laboratory for assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: No InterventionAssessment of tumor biopsies and histological preparations of participants diagnosed with peripheral T-cell lymphoma (PTCL) in the six years between 01 January 2008 and 31 December 2013 will be performed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants diagnosed with PTCL in the six years between 01 January 2008 and 31 December 2013 in the participating sites.
Key inclusion criteria (10 listed)
- Participants diagnosed with PTCL in the six years between 01/01/2008 and 31/12/2013.
- Availability of initial tumor biopsy diagnosis in paraffin block (node or core biopsy of 16-18mm).
- PTCL subtypes permitted by WHO 2008 classification of lymphoid neoplasms:
Key exclusion criteria (1 listed)
- Participants with an unavailable history (lost, empty or not recoverable).
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 |
|---|---|---|
| No Intervention | Other | Cohort 1 |
Primary outcome
Distribution of Peripheral T-cell Lymphoma (PTCL) Subtypes
Time frame: Up to 6 months
Distribution of PTCL subtypes by re-analysis and re-classification of samples according to the 2008 WHO classification of lymphoid neoplasms will be estimated.
8 secondary outcomes
Percentage of Participants with Each Subtypes of PTCL
Time frame: Up to 6 months
Rate of Discrepancy Between the Initial Diagnosis and Re-analysis and Re-classification
Time frame: Up to 6 months
Expression of Cluster of Differentiation 30 (CD30) by Immunohistochemistry and Quantitative Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) in Different Subtypes of PTCL
Time frame: Up to 6 months
Correlation Between the Expression of CD30 and Lymphoid Lineage
Time frame: Up to 6 months
Correlation Between the Expression of CD30, Prognostic Indices Used In PTCL and Survival
Time frame: Up to 6 months
Classification of Peripheral T-cell Lymphoma
Time frame: Up to 6 months
T-cell Clonality in PTCL
Time frame: Up to 6 months
Correlation Between Most frequent Mutations and Clinical, Phenotypic Factors
Time frame: Up to 6 months
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 21 Mar 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.
Medical Director Clinical Science study director
Takeda
10 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, T-Cell, Peripheral, run by Takeda at 10 sites 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 10 inclusion and 1 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 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 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?
Distribution of Peripheral T-cell Lymphoma (PTCL) Subtypes (time frame: Up to 6 months). 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 21 Mar 2017.