Collecting and Storing Tissue Samples From Patients With Rare or Cutaneous Non-Hodgkin Lymphoma
Basic Trial Information
|No phase specified||Natural history/Epidemiology, Tissue collection/Repository||Active||0 to 21 years||NCI, Other||ANHL04B1|
COG-ANHL04B1, NCI-2009-00406, NCT01000753
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
- 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.
- 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
- 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
- National Cancer Institute
Saint Peter's University Hospital
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01000753
ClinicalTrials.gov processed this data on May 12, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.