T-cell LymphomaTcell-BrazilNCT03207789
T-cell Brazil: Prospective Collection of Data in T-cell Lymphomas Patients
An observational study of T-cell Lymphoma and NK-Cell Lymphoma, run by Grupo de Estudos Multicentricos em Onco-Hematologia.
Trial summary
The designed study follows up on the previous one by the international T-cell project (Bellei et al,, 2012) and its purpose is to verify whether a prospective collection of data would permit access to more accurate information permitting a better definition of prognosis and investigation of more adequate treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T-cell Lymphoma, NK-Cell Lymphoma, T-cell Lymphoma Adults
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Dec 2020
- How long will I take part?
- 5 Years
- 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 with confirmed histologically diagnosis of T-cell or NH-cell lymphoma in any of 5 macro region of Brazil
Who may be able to join
- Dated and signed informed consent;
- T-cell or NK-cell diagnosis;
- Tissue biopsies adequate for diagnosis and classification and available for centralized review;
- clinical, laboratory, image data available and registred in the website.
Who cannot join
- -
About this study
Official title: Prospective Collection of Data in Patients With T-cell Lymphomas Distributed in the Five Distinct Macro Regions of Brazil
The designed study follows up on the previous one by the international T-cell project (Bellei et al,, 2012) and its purpose is to verify whether a prospective collection of data would permit access to more accurate information permitting a better definition of prognosis and investigation of more adequate treatment strategies for these neoplasms.
The analysis of patients distributed in all five macro regions of the country and a comparison among them will provide a real picture of the disease in Brazil, limiting the bias probably found in the previous projects.
Read the detailed description
Patients with diagnosis histologically confirmed T-cell or NK-cell lymphoma will be registered in the study, despite of their planned treatment. Registration will be made on-line on a key restricted accessible web-database after obtaining the informed consent dated and signed by the patient. Every registered patient has as well to undergo a central histopathology review by a panel of experts. The referring pathologist will collect and review the patological material sent by the participating centers, without knowing the clinical outcome of the patient. Validated cases have to be supplied of information regarding treatment procedures and follow up updating for at least 5 years. The primary endpoint is the overall survival and other endpoints such as event free survival; progression free survival, complete and partial response rates.
- Conditions
- T-cell Lymphoma, NK-Cell Lymphoma, T-cell Lymphoma Adults
- Medical subject headings
- Lymphoma, T-Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive analysis during the first year of T-cell Brazil Registry
Descriptive analysis and Overall survival
Measured: 12 months of registring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start1 Jan 2015
- Primary completion1 Jun 2017
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-cell LymphomaStudies 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
- Cross-sectional
- Enrolment
- 500 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Grupo de Estudos Multicentricos em Onco-Hematologia
- Sponsor type
- Research network
- Collaborators
- Takeda
- Responsible party
- Sponsor
- Investigators
- Eliana CM Miranda, M.Ed.; Ph.D., Study chair, Grupo de Estudos Multicentricos em Onco-Hematologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207789
- Sponsor's protocol ID
- CAAE: 69605517.1.1001.5487
- Acronym
- Tcell-Brazil
- Status last verified
- Jun 2017
- First submitted
- 30 Jun 2017
- Last updated
- 5 Jul 2017
- 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 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Collection of Data in Patients With T-cell Lymphomas Distributed in the Five Distinct Macro Regions of Brazil
- ClinicalTrials.gov ID
- NCT03207789
- Acronym / sponsor ID
- Tcell-Brazil / CAAE: 69605517.1.1001.5487
- Conditions
- T-cell Lymphoma, NK-Cell Lymphoma, T-cell Lymphoma Adults
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Grupo de Estudos Multicentricos em Onco-HematologiaResearch network
- Collaborators
- Takeda
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 5 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.
The designed study follows up on the previous one by the international T-cell project (Bellei et al,, 2012) and its purpose is to verify whether a prospective collection of data would permit access to more accurate information permitting a better definition of prognosis and investigation of more adequate treatment strategies for these neoplasms.
The analysis of patients distributed in all five macro regions of the country and a comparison among them will provide a real picture of the disease in Brazil, limiting the bias probably found in the previous projects.
Detailed description
Patients with diagnosis histologically confirmed T-cell or NK-cell lymphoma will be registered in the study, despite of their planned treatment. Registration will be made on-line on a key restricted accessible web-database after obtaining the informed consent dated and signed by the patient. Every registered patient has as well to undergo a central histopathology review by a panel of experts. The referring pathologist will collect and review the patological material sent by the participating centers, without knowing the clinical outcome of the patient. Validated cases have to be supplied of information regarding treatment procedures and follow up updating for at least 5 years. The primary endpoint is the overall survival and other endpoints such as event free survival; progression free survival, complete and partial response rates.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed histologically diagnosis of T-cell or NH-cell lymphoma in any of 5 macro region of Brazil
Key inclusion criteria (4 listed)
- Dated and signed informed consent;
- T-cell or NK-cell diagnosis;
- Tissue biopsies adequate for diagnosis and classification and available for centralized review;
- clinical, laboratory, image data available and registred in the website.
Key exclusion criteria (1 listed)
- -
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
Descriptive analysis during the first year of T-cell Brazil Registry
Time frame: 12 months of registring
Descriptive analysis and Overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
- 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.
Eliana CM Miranda, M.Ed.; Ph.D. study chair
Grupo de Estudos Multicentricos em Onco-Hematologia
Questions about this trial
What is this clinical trial studying?
An observational study of T-cell Lymphoma and NK-Cell Lymphoma, run by Grupo de Estudos Multicentricos em Onco-Hematologia.
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 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: status not confirmed, as of the sponsor's last update on 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Descriptive analysis during the first year of T-cell Brazil Registry (time frame: 12 months of registring). 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 5 Jul 2017.