Peripheral T-Cell LymphomaNCT00705809
T-Cell Project: Epidemiologic Component
An observational study of Peripheral T-Cell Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: The T-Cell Project, sponsored by the International T-cell non-Hodgkin Lymphoma Study Group, is a consortium of institutions interested in achieving more detailed information on clinical and biological characteristics of T-cell lymphomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T-Cell Lymphoma
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2008to 20 Jul 2011
- 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
Who may be able to join
- Age greater than or equal to 18 years
- Histologically confirmed Periperal T-cell lymphoma on or after September 1, 2006
Who cannot join
- Age less than 18 years
- Cases without histological confirmation
- Cases diagnosed prior to September 1, 2006
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- The T-Cell Project, sponsored by the International T-cell non-Hodgkin Lymphoma Study Group, is a consortium of institutions interested in achieving more detailed information on clinical and biological characteristics of T-cell lymphomas.
- The T-Cell Project serves as a repository for data on patients with peripheral T-cell lymphoma (PTCL) worldwide. Its overall goal is to improve T-cell subtype classifications and evaluate treatment strategies for each subtype.
Read more
Objectives:
-To implement a standardized epidemiologic questionnaire into the ongoing T-Cell Project to allow evaluation of various potential risk factors for PTLCs.
Eligibility:
-Untreated patients 18 years of age and older who were diagnosed with PTLC September 1, 2006, or later.
Design:
-Patients complete a questionnaire containing the following information:
Demographic information
Smoking history and alcohol use
Personal history or cancer
History of cancer among first-degree relatives
Medical history
History of transplants
History of blood transfusions
Medication use
Occupational and residential history
Pesticide treatment
-The information collected is linked to clinical and pathologic information in the T-Cell Project database.
Read the detailed description
Peripheral T-cell lymphomas (PTCLs) comprise a heterogeneous group of neoplasms that are derived from post-thymic lymphoid cells at different stages of differentiation with different morphological patterns, phenotypes, and clinical presentations. Although a number of case-control studies on non-Hodgkin lymphoma (NHL) have identified various risk factors for disease, including autoimmune conditions, family history of hematopoietic malignancies, smoking, hepatitis C infection, and host susceptibility, these risk factors largely pertain to B-cell lymphoma subtypes as they comprise well over 90 percent of all NHLs. At present, there are no known epidemiologic risk factors for PTCL or its subtypes. This is largely due to the lack of sample size of PTCL in any one epidemiologic study. The aim of this proposal is to implement a standardized epidemiologic risk factor questionnaire into the on-going T-Cell Project. Briefly, the T-Cell Project is an international consortium of on-going clinical trials on peripheral PTCL. It serves as a prospective collection of patients (greater than 18 years) worldwide with PTCL who are enrolled at participating medical institutions for treatment in a clinical trial. The overall goal of the T-Cell Project is to improve current T-cell subtype classifications and to evaluate different treatment strategies for each T-cell subtype. The specific goal of our proposal is to implement, within the T-Cell Project, a 20-minute standardized epidemiologic questionnaire to allow evaluation of various potential risk factors for T-cell lymphomas. Importantly, there are currently no known epidemiologic risk factors for PTCL. We plan to administer questionnaires to 800 PTCL patients; if successful this collection would be the largest database of PTCLs to date with epidemiologic data. If the questionnaire implementation of assessing epidemiological risk factors for PTCL among patients in the T-Cell Project is found logistically feasible, then descriptive and analytic epidemiologic analyses of the collected data to understand the etiology of PTCL would be pursued at the NCI in collaboration with members of the T-Cell Project. For such analyses, NCI would receive only fully anonymized and de-linked data with no identifiers.
- Conditions
- Peripheral T-Cell Lymphoma
- Keywords
- Epidemiology, Peripheral T-Cell Lymphoma
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2008 (estimated)
- Study start18 Jun 2008
- Study completion20 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peripheral T-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705809
- Sponsor's protocol ID
- 999908163
- Other IDs
- 08-C-N163
- Status last verified
- 20 Jul 2011
- First submitted
- 25 Jun 2008
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Delves PJ, Roitt IM. The immune system. Second of two parts. N Engl J Med. 2000 Jul 13;343(2):108-17. doi: 10.1056/NEJM200007133430207. No abstract available.
PubMed 10891520Delves PJ, Roitt IM. The immune system. First of two parts. N Engl J Med. 2000 Jul 6;343(1):37-49. doi: 10.1056/NEJM200007063430107. No abstract available.
PubMed 10882768Jones D, O'Hara C, Kraus MD, Perez-Atayde AR, Shahsafaei A, Wu L, Dorfman DM. Expression pattern of T-cell-associated chemokine receptors and their chemokines correlates with specific subtypes of T-cell non-Hodgkin lymphoma. Blood. 2000 Jul 15;96(2):685-90.
PubMed 10887135
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T-Cell Project: Epidemiologic Component
- ClinicalTrials.gov ID
- NCT00705809
- Acronym / sponsor ID
- 999908163
- Conditions
- Peripheral T-Cell Lymphoma
- Keywords
- Epidemiology, Peripheral T-Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 18 Jun 2008
- Study completion
- 20 Jul 2011
- First posted
- 26 Jun 2008 (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.
Background:
- The T-Cell Project, sponsored by the International T-cell non-Hodgkin Lymphoma Study Group, is a consortium of institutions interested in achieving more detailed information on clinical and biological characteristics of T-cell lymphomas.
- The T-Cell Project serves as a repository for data on patients with peripheral T-cell lymphoma (PTCL) worldwide. Its overall goal is to improve T-cell subtype classifications and evaluate treatment strategies for each subtype.
Objectives:
-To implement a standardized epidemiologic questionnaire into the ongoing T-Cell Project to allow evaluation of various potential risk factors for PTLCs.
Eligibility:
-Untreated patients 18 years of age and older who were diagnosed with PTLC September 1, 2006, or later.
Design:
-Patients complete a questionnaire containing the following information:
Demographic information
Smoking history and alcohol use
Personal history or cancer
History of cancer among first-degree relatives
Medical history
History of transplants
History of blood transfusions
Medication use
Occupational and residential history
Pesticide treatment
-The information collected is linked to clinical and pathologic information in the T-Cell Project database.
Detailed description
Peripheral T-cell lymphomas (PTCLs) comprise a heterogeneous group of neoplasms that are derived from post-thymic lymphoid cells at different stages of differentiation with different morphological patterns, phenotypes, and clinical presentations. Although a number of case-control studies on non-Hodgkin lymphoma (NHL) have identified various risk factors for disease, including autoimmune conditions, family history of hematopoietic malignancies, smoking, hepatitis C infection, and host susceptibility, these risk factors largely pertain to B-cell lymphoma subtypes as they comprise well over 90 percent of all NHLs. At present, there are no known epidemiologic risk factors for PTCL or its subtypes. This is largely due to the lack of sample size of PTCL in any one epidemiologic study. The aim of this proposal is to implement a standardized epidemiologic risk factor questionnaire into the on-going T-Cell Project. Briefly, the T-Cell Project is an international consortium of on-going clinical trials on peripheral PTCL. It serves as a prospective collection of patients (greater than 18 years) worldwide with PTCL who are enrolled at participating medical institutions for treatment in a clinical trial. The overall goal of the T-Cell Project is to improve current T-cell subtype classifications and to evaluate different treatment strategies for each T-cell subtype. The specific goal of our proposal is to implement, within the T-Cell Project, a 20-minute standardized epidemiologic questionnaire to allow evaluation of various potential risk factors for T-cell lymphomas. Importantly, there are currently no known epidemiologic risk factors for PTCL. We plan to administer questionnaires to 800 PTCL patients; if successful this collection would be the largest database of PTCLs to date with epidemiologic data. If the questionnaire implementation of assessing epidemiological risk factors for PTCL among patients in the T-Cell Project is found logistically feasible, then descriptive and analytic epidemiologic analyses of the collected data to understand the etiology of PTCL would be pursued at the NCI in collaboration with members of the T-Cell Project. For such analyses, NCI would receive only fully anonymized and de-linked data with no identifiers.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age greater than or equal to 18 years
- Histologically confirmed Periperal T-cell lymphoma on or after September 1, 2006
Key exclusion criteria (3 listed)
- Age less than 18 years
- Cases without histological confirmation
- Cases diagnosed prior to September 1, 2006
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
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 10891520Delves PJ, Roitt IM. The immune system. Second of two parts. N Engl J Med. 2000 Jul 13;343(2):108-17. doi: 10.1056/NEJM200007133430207. No abstract available.
- Background: PubMed 10882768Delves PJ, Roitt IM. The immune system. First of two parts. N Engl J Med. 2000 Jul 6;343(1):37-49. doi: 10.1056/NEJM200007063430107. No abstract available.
- Background: PubMed 10887135Jones D, O'Hara C, Kraus MD, Perez-Atayde AR, Shahsafaei A, Wu L, Dorfman DM. Expression pattern of T-cell-associated chemokine receptors and their chemokines correlates with specific subtypes of T-cell non-Hodgkin lymphoma. Blood. 2000 Jul 15;96(2):685-90.
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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 Peripheral T-Cell Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.
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 2 inclusion and 3 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 2 Jul 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 States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00705809, which also lists 3 linked publications.
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 2 Jul 2017.