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Collecting and Storing Tissue Samples From Patients With Rare or Cutaneous Non-Hodgkin Lymphoma

C

Children's Oncology Group

Status

Completed

Conditions

Lymphoproliferative Disorder
Marginal Zone Lymphoma
Grade 1 Follicular Lymphoma
Small Lymphocytic Lymphoma
Mantle Cell Lymphoma
Adult Immunoblastic Lymphoma
Childhood Immunoblastic Lymphoma
Primary Cutaneous B-Cell Non-Hodgkin Lymphoma
Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
Non-Hodgkin Lymphoma
Grade 3 Follicular Lymphoma
Grade 2 Follicular Lymphoma
Central Nervous System Non-Hodgkin Lymphoma

Treatments

Other: Cytology Specimen Collection Procedure

Study type

Observational

Funder types

NETWORK
NIH

Identifiers

NCT01000753
ANHL04B1 (Other Identifier)
COG-ANHL04B1
NCI-2009-00406 (Registry Identifier)
U10CA098543 (U.S. NIH Grant/Contract)
CDR0000404164
UG1CA189958 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This research study is collecting and storing tissue samples from patients with rare or cutaneous non-Hodgkin lymphoma. Collecting and storing samples of tissue from patients with cancer to test in the laboratory may help the study of cancer in the future.

Full description

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.

Enrollment

174 patients

Sex

All

Ages

Under 21 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • 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

Trial design

174 participants in 1 patient group

Observational (specimen collection)
Description:
See Detailed Description
Treatment:
Other: Cytology Specimen Collection Procedure

Trial contacts and locations

130

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Data sourced from clinicaltrials.gov

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