Collecting and Storing Tissue Samples From Patients With Rare or Cutaneous Non-Hodgkin Lymphoma
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| ClinicalTrials.gov Identifier: NCT01000753 |
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Recruitment Status :
Active, not recruiting
First Posted : October 23, 2009
Last Update Posted : October 14, 2019
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| Condition or disease | Intervention/treatment |
|---|---|
| Adult Immunoblastic Lymphoma Central Nervous System Non-Hodgkin Lymphoma Childhood Immunoblastic Lymphoma Grade 1 Follicular Lymphoma Grade 2 Follicular Lymphoma Grade 3 Follicular Lymphoma Lymphoproliferative Disorder Mantle Cell Lymphoma Marginal Zone Lymphoma Non-Hodgkin Lymphoma Primary Cutaneous B-Cell Non-Hodgkin Lymphoma Primary Cutaneous T-Cell Non-Hodgkin Lymphoma Small Lymphocytic Lymphoma | Other: Cytology Specimen Collection Procedure |
OBJECTIVES:
I. To determine the clinical features, treatment, and outcome of patients with rare or cutaneous pediatric non-Hodgkin lymphoma (NHL).
II. To determine the pathologic and biologic features of these diseases, including molecular diagnostics and flow cytometry.
III. To establish a bank of these pathologically reviewed diseases and make specimens of blood and tissue available to qualified researchers.
IV. To determine sub-groups of these diseases that could be targeted for future biologic, pathologic, or therapeutic studies.
OUTLINE:
On study data will include presenting symptoms and signs, physical description of the tumor if it is on the skin, results of metastatic evaluation, stage (if available), blood count, markers, and the results of viral serologies. Any existing underlying conditions that could predispose to lymphoma will also be noted. Demographic and outcomes data will be stored and maintained by the COG Research Data Center. Demographic data will be linked to the specimen data in the BPC database.
The approach of this study is prospective data collection, including central pathologic review, relevant biologic studies, submission of material to the Biopathology Center (BPC) and collection of diagnostic and outcome data. Participants will be registered with a standard COG registration form for documentation of age, gender, race, date of diagnosis, initial presentation, initial work-up, and stage according to the standard staging for the specific disease, initial diagnostic procedure, and institutional diagnosis. Tissue will be sent according to guidelines in Section 4.0. Follow-up data, including relapse or progression and vital status will be reported annually for 5 years.
Patients will be followed annually for 5 years and data will be collected including vital status, evidence/absence of disease, type of treatment received, progression/relapse and whether the patient continues on study.
| Study Type : | Observational |
| Actual Enrollment : | 174 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Rare And Cutaneous Non-Hodgkin Lymphoma Registry |
| Actual Study Start Date : | May 30, 2005 |
| Actual Primary Completion Date : | June 1, 2007 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Observational (specimen collection)
See Detailed Description
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Other: Cytology Specimen Collection Procedure
Correlative studies
Other Name: Cytologic Sampling |
- Clinical features, treatment, and outcomes [ Time Frame: Up to 5 years ]
- Pathologic and biologic features of these diseases, including molecular diagnostics and flow cytometry [ Time Frame: Up to 5 years ]
- Establishment of a bank of these pathologically reviewed diseases and make specimens of blood and tissue available to qualified researchers [ Time Frame: Up to 5 years ]
- Sub-groups of these diseases that could be targeted for future biologic, pathologic, or therapeutic studies [ Time Frame: Up to 5 years ]
Biospecimen Retention: Samples Without DNA
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| Ages Eligible for Study: | up to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
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Diagnosis of NHL
- Any histology, except for Burkitt or Burkitt-like, diffuse large B-cell, anaplastic large cell, or lymphoblastic lymphoma
- Primary CNS, primary cutaneous NHL, or lymphoproliferative diseases of any histology allowed
- Pathological specimen from site not treated within the past 6 months
- Must have specimens available
- At least 6 months since prior chemotherapy irradiation to study lesion
- At least 2 weeks since prior steroids
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000753
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| Principal Investigator: | Amanda M Termuhlen | Children's Oncology Group |
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01000753 |
| Other Study ID Numbers: |
ANHL04B1 NCI-2009-00406 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) COG-ANHL04B1 CDR0000404164 ANHL04B1 ( Other Identifier: Childrens Oncology Group ) ANHL04B1 ( Other Identifier: CTEP ) U10CA098543 ( U.S. NIH Grant/Contract ) UG1CA189958 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 23, 2009 Key Record Dates |
| Last Update Posted: | October 14, 2019 |
| Last Verified: | October 2019 |
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Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma, Mantle-Cell Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoma, B-Cell Plasmablastic Lymphoma Lymphoma, Large-Cell, Immunoblastic |
Lymphoproliferative Disorders Neoplasms by Histologic Type Neoplasms Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Leukemia, Lymphoid Leukemia Lymphoma, Large B-Cell, Diffuse |