Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Collecting and storing samples of tissue from patients with cancer to test in the laboratory may help the study of cancer in the future.

PURPOSE: This research study is collecting and storing tissue samples from patients with rare or cutaneous non-Hodgkin lymphoma.

Further Study Information

OBJECTIVES:

• To determine the clinical features, treatment, and outcome of patients with rare or cutaneous pediatric non-Hodgkin lymphoma (NHL).

• To determine the pathologic and biologic features of these diseases, including molecular diagnostics and flow cytometry.

• To establish a bank of these pathologically reviewed diseases and make specimens of blood and tissue available to qualified researchers.

• 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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of non-Hodgkin lymphoma (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

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 6 months since prior chemotherapy irradiation to study lesion

• At least 2 weeks since prior steroids

Trial Contact Information

Trial Lead Organizations/Sponsors

Children's Oncology Group

Amanda M. Termuhlen

Study Chair

U.S.A.
New Jersey
	New Brunswick
	Saint Peter's University Hospital
		Stanley Calderwood	Ph: 732-745-8600ext6163
			Email: kcovert@saintpetersuh.com

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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01000753
Information obtained from ClinicalTrials.gov on November 26, 2012

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