Collecting and Storing Tissue Samples From Patients With Rare or Cutaneous Non-Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT01000753|
Recruitment Status : Active, not recruiting
First Posted : October 23, 2009
Last Update Posted : December 13, 2017
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.
|Condition or disease||Intervention/treatment|
|Lymphoma Lymphoproliferative Disorder||Other: biologic sample preservation procedure Other: informational intervention|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Rare And Cutaneous Non-Hodgkin Lymphoma Registry|
|Study Start Date :||May 2005|
|Estimated Primary Completion Date :||January 2100|
|Estimated Study Completion Date :||January 2100|
Ancillary-Correlative - All patients
The submission of biology specimens from all surgical procedures is optional but encouraged. Bone marrow specimens and biopsy of tumor tissue for this study are only to be obtained at the time the procedure is being done for clinical care.
Other: biologic sample preservation procedure
Other: informational intervention
- Clinical features, treatment, and outcomes [ Time Frame: length of study ]
- Pathologic and biologic features of these diseases, including molecular diagnostics and flow cytometry [ Time Frame: length of study ]
- Establishment of a bank of these pathologically reviewed diseases and make specimens of blood and tissue available to qualified researchers [ Time Frame: length of study ]
- Sub-groups of these diseases that could be targeted for future biologic, pathologic, or therapeutic studies [ Time Frame: length of study ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000753
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|Study Chair:||Amanda M. Termuhlen, MD||Nationwide Children's Hospital|