- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01804166
A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL)
February 12, 2021 updated by: Janssen Scientific Affairs, LLC
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Norfolk, Virginia, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with Inflammatory Bowel Disease with a confirmed diagnosis of Hepatosplenic T-cell Lymphoma
- Provide written informed consent (either by the patient or his/her legal representative). Consent from a legally acceptable representative of a deceased patient will be obtained for enrollment into the study and sample collection
- Be willing to provide a tumor biopsy sample for the study
Exclusion Criteria:
- Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments
- Is unable to provide critical clinical and/or demographic patient and/or sample information
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: IBD patients with HSTCL
Subjects with Inflammatory Bowel Disease with a diagnosis of Hepatosplenic T-cell lymphoma
|
This study will not restrict or introduce any therapeutic interventions, including medications.
Participants may continue to receive infliximab as instructed by their personal physicians.
Other Names:
This study will not restrict or introduce any therapeutic interventions, including medications.
Participants may continue to receive golimumab as instructed by their personal physicians.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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)
Time Frame: Approximately up to 8 years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Study Director, Janssen Scientific Affairs, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 21, 2013
Primary Completion (Actual)
February 28, 2020
Study Completion (Actual)
February 28, 2020
Study Registration Dates
First Submitted
February 1, 2013
First Submitted That Met QC Criteria
March 1, 2013
First Posted (Estimate)
March 5, 2013
Study Record Updates
Last Update Posted (Actual)
March 4, 2021
Last Update Submitted That Met QC Criteria
February 12, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Gastrointestinal Diseases
- Gastroenteritis
- Colonic Diseases
- Intestinal Diseases
- Inflammatory Bowel Diseases
- Lymphoma
- Ulcer
- Crohn Disease
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Colitis
- Colitis, Ulcerative
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gastrointestinal Agents
- Dermatologic Agents
- Tumor Necrosis Factor Inhibitors
- Infliximab
- Golimumab
Other Study ID Numbers
- CR100938 (Registry Identifier: Janssen Scientific Affairs, LLC)
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hepatosplenic T-Cell Lymphoma
-
Centocor Ortho Biotech Services, L.L.C.CompletedHepatosplenic T-cell LymphomaNetherlands
-
University of NebraskaNational Cancer Institute (NCI); Spectrum Pharmaceuticals, IncCompletedPeripheral T-cell Lymphoma | Anaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Hepatosplenic T-cell LymphomaUnited States
-
National Cancer Institute (NCI)WithdrawnHepatosplenic T-cell Lymphoma | Enteropathy-Associated T-Cell Lymphoma | Adult T-cell Leukemia/Lymphoma | Extranodal NK-/T-cell Lymphoma, Nasal Type | Monomorphic Epiteliotrophic Intestinal T-cell LymphomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedMycosis Fungoides | Recurrent Angioimmunoblastic T-Cell Lymphoma | Refractory Angioimmunoblastic T-Cell Lymphoma | Refractory Anaplastic Large Cell Lymphoma | Recurrent Anaplastic Large Cell Lymphoma | Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified | Recurrent Enteropathy-Associated... and other conditionsUnited States
-
Northwestern UniversityNational Cancer Institute (NCI); Merck Sharp & Dohme LLC; Seagen Inc.WithdrawnBrentuximab Vedotin and Pembrolizumab in Treating Patients With Recurrent Peripheral T-Cell LymphomaRecurrent Angioimmunoblastic T-Cell Lymphoma | Refractory Angioimmunoblastic T-Cell Lymphoma | Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified | Recurrent Enteropathy-Associated T-Cell Lymphoma | Recurrent Follicular T-Cell Lymphoma | Recurrent Hepatosplenic T-Cell Lymphoma | Recurrent... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedSubcutaneous Panniculitis-Like T-Cell Lymphoma | T-Cell Peripheral Lymphoma | Gamma Delta Hepatosplenic T-Cell Lymphoma | NK T-Cell LymphomaUnited States
-
Royal Marsden NHS Foundation TrustCancer Research UKUnknownAngioimmunoblastic T-cell Lymphoma | Enteropathy-Associated T-Cell Lymphoma | Anaplastic Large Cell Lymphoma, ALK-Negative | Peripheral T-cell Lymphoma NOS | Hepatosplenic Gamma/ Delta T-cell LymphomaUnited Kingdom
-
National Cancer Institute (NCI)CompletedAnaplastic Large Cell Lymphoma | Recurrent Adult Non-Hodgkin Lymphoma | Angioimmunoblastic T-Cell Lymphoma | Hepatosplenic T-Cell Lymphoma | Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma | Recurrent Adult T-Cell Leukemia/Lymphoma | Adult Nasal Type Extranodal NK/T-Cell LymphomaUnited States, Canada
-
Shandong Provincial HospitalUnknownHepatosplenic T-cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ALK-negative Anaplastic Large Cell Lymphoma | Angioimmunoblastic T Cell Lymphoma | Enteropathy Associated T Cell Lymphoma | Subcutaneous Panniculitis Like T Cell LymphomaChina
-
Ruijin HospitalUnknownALK-negative Anaplastic Large Cell Lymphoma | Peripherial T Cell Lymphoma,Not Otherwise Specified | Angioimmunoblastic T Cell Lymphoma | Enteropathy Associated T Cell Lymphoma | Hepatosplenic T Cell Lymphoma | Subcutaneous Panniculitis Like T Cell LymphomaChina
Clinical Trials on Infliximab
-
Onze Lieve Vrouwe GasthuisSanteonUnknown
-
Merck Sharp & Dohme LLCIntegrated Therapeutics GroupTerminatedRheumatoid Arthritis
-
Diakonhjemmet HospitalSouth-Eastern Norway Regional Health AuthorityCompletedRheumatoid Arthritis | Crohn's Disease | Ulcerative Colitis | Psoriatic Arthritis | Spondyloarthritis | Psoriasis ChronicNorway
-
PfizerCompleted
-
NYU Langone HealthWithdrawnInflammatory Bowel Disease
-
Centre hospitalier de l'Université de Montréal...Ottawa Hospital Research Institute; Maisonneuve-Rosemont Hospital; Niagara Health... and other collaboratorsRecruiting
-
PfizerCompletedPsoriasis Vulgaris | Pustular Psoriasis | Psoriasis Arthropathica | Erythrodermic PsoriasisJapan
-
Janssen Research & Development, LLCJanssen Biologics BVCompletedUlcerative ColitisUnited States, France, United Kingdom, Belgium, Switzerland, Israel, Canada, Australia, Netherlands, New Zealand, Austria, Germany, Denmark, Czechia, Argentina
-
BiocadCompletedAnkylosing SpondylitisRussian Federation, Belarus
-
European Organisation for Research and Treatment...CompletedMyelodysplastic SyndromesFrance, Belgium, Netherlands, Czech Republic, Italy, Germany