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

Completed

• Conditions: Adult Immunoblastic Lymphoma; Grade 1 Follicular Lymphoma; Mantle Cell Lymphoma; Non-Hodgkin Lymphoma; Primary Cutaneous B-Cell Non-Hodgkin Lymphoma; Grade 2 Follicular Lymphoma; Lymphoproliferative Disorder; Small Lymphocytic Lymphoma; Childhood Immunoblastic Lymphoma; Marginal Zone Lymphoma

• Registration Number: NCT01000753
• Lead Sponsor: Children's Oncology Group

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2005-05-30
• Primary Completion: 2007-06-01
• Study First Submitted: 2009-10-22
• Study First Submitted QC: 2009-10-22
• Study First Posted: 2009-10-23
• Study Completion: 2023-09-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sub-groups of these diseases that could be targeted for future biologic, pathologic, or therapeutic studies	Up to 5 years
Pathologic and biologic features of these diseases, including molecular diagnostics and flow cytometry	Up to 5 years
Establishment of a bank of these pathologically reviewed diseases and make specimens of blood and tissue available to qualified researchers	Up to 5 years
Clinical features, treatment, and outcomes	Up to 5 years

Trial Locations

Locations (130)

Children's Hospital of Alabama; 🇺🇸 Birmingham, Alabama, United States

University of Alabama at Birmingham Cancer Center; 🇺🇸 Birmingham, Alabama, United States

Phoenix Childrens Hospital; 🇺🇸 Phoenix, Arizona, United States

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Kaiser Permanente Downey Medical Center; 🇺🇸 Downey, California, United States

Miller Children's and Women's Hospital Long Beach; 🇺🇸 Long Beach, California, United States

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

Children's Hospital and Research Center at Oakland; 🇺🇸 Oakland, California, United States

Kaiser Permanente-Oakland; 🇺🇸 Oakland, California, United States

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