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Clinical Trials/NCT01000753
NCT01000753
Completed
Not Applicable

Rare And Cutaneous Non-Hodgkin Lymphoma Registry

Children's Oncology Group130 sites in 1 country174 target enrollmentMay 30, 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adult Immunoblastic Lymphoma
Sponsor
Children's Oncology Group
Enrollment
174
Locations
130
Primary Endpoint
Sub-groups of these diseases that could be targeted for future biologic, pathologic, or therapeutic studies
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 30, 2005
End Date
September 30, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Sub-groups of these diseases that could be targeted for future biologic, pathologic, or therapeutic studies

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

Clinical features, treatment, and outcomes

Time Frame: Up to 5 years

Study Sites (130)

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