Hepatosplenic T-cell LymphomaNCT00731536
Observational Study on the Occurrence of Hepatosplenic T-cell Lymphoma in Patients of Netherlands
An observational study of Hepatosplenic T-cell Lymphoma, run by Centocor Ortho Biotech Services, L.L.C. at 10 sites in Netherlands.
Trial summary
The purpose of this study is to examine reports of the cancer called hepatosplenic T-cell lymphoma (HSTCL) in the Dutch National Database of Pathology (Pathologisch-Anatomisch Landelijk Geautomatiseerd Archief or PALGA) during the years 1995 to 2008. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatosplenic T-cell Lymphoma
- How many people
- 15 participants
- Where
- 10 sitesNetherlands
- Study dates
- Oct 2008to Apr 2010
- 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: Patients with Hepatosplenic T-cell Lymphoma (HSTCL).
Who may be able to join
- Patients diagnosed with HSTCL in the Dutch National Database of Pathology (Pathologisch-Anatomisch Landelijk Geautomatiseerd Archief) database during the years 1995 to 2008
Who cannot join
- Patients who are not diagnosed with HSTCL
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Netherlands10 sites
Study site
Alkmaar
Study site
Amsterdam
Study site
Amsterdam-Zuidoost
Study site
Eindhoven
Study site
Groningen
Study site
Nijmegen
Study site
Oss
Study site
Rotterdam
Study site
Utrecht
Study site
Winschoten
About this study
Official title: A Retrospective Review of Reports of Hepatosplenic T-cell Lymphoma in the Dutch National Database of Pathology (Pathologisch-Anatomisch Landelijk Geautomatiseerd Archief [PALGA]), a Database of Pathology Results for The Netherlands
The purpose of this study is to examine reports of the cancer called hepatosplenic T-cell lymphoma (HSTCL) in the Dutch National Database of Pathology (Pathologisch-Anatomisch Landelijk Geautomatiseerd Archief or PALGA) during the years 1995 to 2008.
Read the detailed description
This is a observational, retrospective (a study in which the participants are identified and then followed backward in time, for the outcome of the study) study. In this study review of all reports of possible cases of hepatosplenic T-cell lymphoma (HSTCL) that were identified within the PALGA database of pathology results for The Netherlands from 1995 to 2008. All patients whose information is contained within the PALGA database were prescribed treatments by a physician on the basis of usual clinical practice or may have received other treatments, including experimental drugs, while participating in an interventional clinical study. The identified data on each of the patients with reports of HSTCL will be collected from the pathologist(s) who prepared the report and from the physician(s) who treated the patient at the time of diagnosis.
- Conditions
- Hepatosplenic T-cell Lymphoma
- Being tested
- No intervention
- Keywords
- Hepatosplenic T-cell Lymphoma, Remicade, Infliximab, Dutch national database of pathology, PALGA, Autoimmune disease, Non-Hodgkin lymphoma
- Medical subject headings
- Autoimmune Diseases, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study. Medical records of patients with the diagnosis of HSTCL in the PALGA database will be analyzed.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Hepatosplenic T-cell Lymphoma (HSTCL) | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with diagnosis of Hepatosplenic T-cell Lymphoma (HSTCL)
Evaluation of the occurrence of the diagnosis of HSTCL among patients with pathology reports in the Pathologisch-Anatomisch Landelijk Geautomatiseerd Archief (PALGA) database during the years 1995 to 2008.
Measured: 1 year
Secondary outcomes (4)
Number of patients with HSTCL that are present in the population of The Netherlands
Number of cases with HSTCL will be used to evaluate the prevalence.
Measured: 1 year
Number of newly diagnosed patients with HSTCL that are present in the population of The Netherlands
Number of newly diagnosed patients with HSTCL will be used to evaluate the incidence of HSTCL.
Measured: 1 year
Number of newly diagnosed patients with HSTCL that are present in the population of The Netherlands prior to and after the availability of infliximab
Number of newly diagnosed patients with HSTCL will be used to evaluate the incidence of HSTCL prior to and after the availability of infliximab.
Measured: 1 year
Data collection for factors associated with the diagnosis of HSTCL
Data collection will include HSCTL diagnosis, diseases and medical/surgical conditions, cytogenetic data, and demographic data.
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 posted11 Aug 2008 (estimated)
- Study startOct 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatosplenic 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centocor Ortho Biotech Services, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Centocor Ortho Biotech Services, L.L.C. Clinical Trial, Study director, Centocor Ortho Biotech Services, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731536
- Sponsor's protocol ID
- CR015394
- Other IDs
- C0168Z06
- Status last verified
- Oct 2013
- First submitted
- 7 Aug 2008
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Review of Reports of Hepatosplenic T-cell Lymphoma in the Dutch National Database of Pathology (Pathologisch-Anatomisch Landelijk Geautomatiseerd Archief [PALGA]), a Database of Pathology Results for The Netherlands
- ClinicalTrials.gov ID
- NCT00731536
- Acronym / sponsor ID
- CR015394
- Conditions
- Hepatosplenic T-cell Lymphoma
- Keywords
- Hepatosplenic T-cell Lymphoma, Remicade, Infliximab, Dutch national database of pathology, PALGA, Autoimmune disease, Non-Hodgkin lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centocor Ortho Biotech Services, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 11 Aug 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.
The purpose of this study is to examine reports of the cancer called hepatosplenic T-cell lymphoma (HSTCL) in the Dutch National Database of Pathology (Pathologisch-Anatomisch Landelijk Geautomatiseerd Archief or PALGA) during the years 1995 to 2008.
Detailed description
This is a observational, retrospective (a study in which the participants are identified and then followed backward in time, for the outcome of the study) study. In this study review of all reports of possible cases of hepatosplenic T-cell lymphoma (HSTCL) that were identified within the PALGA database of pathology results for The Netherlands from 1995 to 2008. All patients whose information is contained within the PALGA database were prescribed treatments by a physician on the basis of usual clinical practice or may have received other treatments, including experimental drugs, while participating in an interventional clinical study. The identified data on each of the patients with reports of HSTCL will be collected from the pathologist(s) who prepared the report and from the physician(s) who treated the patient at the time of diagnosis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Hepatosplenic T-cell Lymphoma (HSTCL) | – | Other: No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Hepatosplenic T-cell Lymphoma (HSTCL).
Key inclusion criteria (1 listed)
- Patients diagnosed with HSTCL in the Dutch National Database of Pathology (Pathologisch-Anatomisch Landelijk Geautomatiseerd Archief) database during the years 1995 to 2008
Key exclusion criteria (1 listed)
- Patients who are not diagnosed with HSTCL
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 interventionThis is an observational study. Medical records of patients with the diagnosis of HSTCL in the PALGA database will be analyzed. | Other | Patients with Hepatosplenic T-cell Lymphoma (HSTCL) |
Primary outcome
Number of patients with diagnosis of Hepatosplenic T-cell Lymphoma (HSTCL)
Time frame: 1 year
Evaluation of the occurrence of the diagnosis of HSTCL among patients with pathology reports in the Pathologisch-Anatomisch Landelijk Geautomatiseerd Archief (PALGA) database during the years 1995 to 2008.
4 secondary outcomes
Number of patients with HSTCL that are present in the population of The Netherlands
Time frame: 1 year
Number of newly diagnosed patients with HSTCL that are present in the population of The Netherlands
Time frame: 1 year
Number of newly diagnosed patients with HSTCL that are present in the population of The Netherlands prior to and after the availability of infliximab
Time frame: 1 year
Data collection for factors associated with the diagnosis of HSTCL
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 16 Oct 2013.
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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.
Centocor Ortho Biotech Services, L.L.C. Clinical Trial study director
Centocor Ortho Biotech Services, L.L.C.
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 Hepatosplenic T-cell Lymphoma, run by Centocor Ortho Biotech Services, L.L.C. at 10 sites in Netherlands.
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 1 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 16 Oct 2013. 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 Netherlands. 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?
Number of patients with diagnosis of Hepatosplenic T-cell Lymphoma (HSTCL) (time frame: 1 year). 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 16 Oct 2013; AzTrials last refreshed its copy on 7 Nov 2026.