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)

• Sponsor: Janssen Scientific Affairs, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01804166
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Arm: 1
• Actual Duration (Months): 83.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatosplenic T-Cell Lymphoma	Drug: Infliximab; Drug: Golimumab	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: 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)
• Actual Study Start Date: Mar 21, 2013
• Actual Primary Completion Date: Feb 28, 2020
• Actual Study Completion Date: Feb 28, 2020

Arms and Interventions

Arm

Intervention/Treatment

Other: IBD patients with HSTCL Subjects with Inflammatory Bowel Disease with a diagnosis of Hepatosplenic T-cell lymphoma

Drug: Infliximab; 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: Remicade ; Drug: Golimumab; 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: Simponi

Outcome Measures

Primary Outcome Measures

1. Number of Samples Collected for the Identification of Biomarkers for Early Evaluation of Risk of Developing Hepatosplenic T-cell Lymphoma (HSTCL) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Norfolk	Virginia	United States

Sponsors and Collaborators

• Janssen Scientific Affairs, LLC

Investigators

• Study Director: Study Director, Janssen Scientific Affairs, LLC

Study Documents (Full-Text)

• Study Protocol - Aug 11, 2017

More Information

Publications

None provided.

• Responsible Party: Janssen Scientific Affairs, LLC
• ClinicalTrials.gov Identifier: NCT01804166
• Other Study ID Numbers: CR100938; CR100938
• First Posted: Mar 5, 2013
• Last Update Posted: Mar 4, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Janssen Scientific Affairs, LLC: Lymphoma, T-Cell, Peripheral, Infliximab, Golimumab, Remicade, Simponi, Ulcerative Colitis, Crohn's Disease, Inflammatory Bowel Disease
• Additional relevant MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Crohn Disease; Colitis; Colitis, Ulcerative; Ulcer; Golimumab; Infliximab

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	IBD Patients With HSTCL
Arm/Group Description	Subjects with Inflammatory Bowel Disease with a diagnosis of Hepatosplenic T-cell lymphoma
Period Title: Overall Study
STARTED	1
COMPLETED	1
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	IBD Patients With HSTCL
Arm/Group Description	Subjects with Inflammatory Bowel Disease with a diagnosis of Hepatosplenic T-cell lymphoma
Overall Participants	0
Age (Years) []
Sex: Female, Male () []
Female
Male
Race (NIH/OMB) () []
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Unknown or Not Reported

Outcome Measures

1. Primary Outcome

Title	Number of Samples Collected for the Identification of Biomarkers for Early Evaluation of Risk of Developing Hepatosplenic T-cell Lymphoma (HSTCL)
Description	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.
Time Frame	Approximately up to 8 years

Outcome Measure Data

Analysis Population Description

Since only one participant completed the study, due to confidentiality issues, no data will be reported.

Arm/Group Title	IBD Patients With HSTCL
Arm/Group Description	Subjects with Inflammatory Bowel Disease with a diagnosis of Hepatosplenic T-cell lymphoma
Measure Participants	0

Adverse Events

Time Frame	Approximately up to 8 years
Arm/Group Title	IBD Patients With HSTCL
Arm/Group Description	Subjects with Inflammatory Bowel Disease with a diagnosis of Hepatosplenic T-cell lymphoma
All Cause Mortality
	IBD Patients With HSTCL
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Serious Adverse Events
	IBD Patients With HSTCL
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Other (Not Including Serious) Adverse Events
	IBD Patients With HSTCL
	Affected / at Risk (%)	# Events
Total	0/1 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.