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| ID | Type | Description | Link |
|---|---|---|---|
| CR100938 | Registry Identifier | Janssen Scientific Affairs, LLC |
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This study is designed to collect tissue samples from the biopsy specimen that was used to diagnose hepatosplenic T-cell lymphoma (HSTCL), additional patient information, and if possible, to obtain additional samples including a single blood sample, a buccal swab sample and/or a bowel tissue sample. Samples obtained will be stored by the sponsor for future testing. In addition, demographic and clinical patient information will be collected. The study will be conducted in North America. Patients eligible for enrollment include males or females with IBD of any age who have a confirmed diagnosis of HSTCL. Patients will be identified through the sponsor's adverse event reporting systems. Cases reported to the sponsor's Medical Information Center will be queried to ascertain if the reporter is interested in participating in the study. Where appropriate, cases may also be identified through the sponsor's new or on-going clinical trials and registries. Samples may be collected from living patients or from stored tissue of deceased patients. This study will not restrict or introduce any therapeutic interventions, including medications. All patients will continue to be managed by their personal physicians. No healthy subjects will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBD patients with HSTCL | Other | Subjects with Inflammatory Bowel Disease with a diagnosis of Hepatosplenic T-cell lymphoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Drug | This study will not restrict or introduce any therapeutic interventions, including medications. Participants may continue to receive infliximab as instructed by their personal physicians. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Samples Collected for the Identification of Biomarkers for Early Evaluation of Risk of Developing Hepatosplenic T-cell Lymphoma (HSTCL) | Samples will be collected from IBD patients diagnosed with HSTCL for future evaluation to identify biomarkers that may allow either earlier evaluation of a participant's risk of developing HSTCL or possibly earlier diagnosis. | Approximately up to 8 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Janssen Scientific Affairs, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norfolk | Virginia | United States |
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Of the 12 subjects the Sponsor attempted to enroll in the study, 1 subject consented and provided a biopsy sample for analysis. No subjects discontinued from the study after enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | IBD Patients With HSTCL | Subjects with Inflammatory Bowel Disease with a diagnosis of Hepatosplenic T-cell lymphoma |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 11, 2017 | Feb 12, 2021 |
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|
| Golimumab | Drug | This study will not restrict or introduce any therapeutic interventions, including medications. Participants may continue to receive golimumab as instructed by their personal physicians. |
|
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| COMPLETED |
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| NOT COMPLETED |
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Since only one participant completed the study, due to confidentiality issues, no data will be reported.
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| ID | Title | Description |
|---|---|---|
| BG000 | IBD Patients With HSTCL | Subjects with Inflammatory Bowel Disease with a diagnosis of Hepatosplenic T-cell lymphoma |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Years | ||||||||||||||||||||||||||||||
| Sex: Female, Male |
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| Race (NIH/OMB) |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Samples Collected for the Identification of Biomarkers for Early Evaluation of Risk of Developing Hepatosplenic T-cell Lymphoma (HSTCL) | Samples will be collected from IBD patients diagnosed with HSTCL for future evaluation to identify biomarkers that may allow either earlier evaluation of a participant's risk of developing HSTCL or possibly earlier diagnosis. | Since only one participant completed the study, due to confidentiality issues, no data will be reported. | Posted | Approximately up to 8 years |
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Approximately up to 8 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IBD Patients With HSTCL | Subjects with Inflammatory Bowel Disease with a diagnosis of Hepatosplenic T-cell lymphoma | 0 | 1 | 0 | 1 | 0 | 1 |
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The low enrollment in this study combined with the limited published information related to biomarkers related to HSTCL limit the ability to interpret and apply any results from this study to the broader IBD population.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Medical Director | Janssen Scientific Affairs, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| C529000 | golimumab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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