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

• Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Children's Oncology Group

Study Description

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.

Condition or disease

Intervention/treatment

Adult Immunoblastic Lymphoma; Central Nervous System Non-Hodgkin Lymphoma; Childhood Immunoblastic Lymphoma; Grade 1 Follicular Lymphoma; Grade 2 Follicular Lymphoma; Grade 3 Follicular Lymphoma; Lymphoproliferative Disorder; Mantle Cell Lymphoma; Marginal Zone Lymphoma; Non-Hodgkin Lymphoma; Primary Cutaneous B-Cell Non-Hodgkin Lymphoma; Primary Cutaneous T-Cell Non-Hodgkin Lymphoma; Small Lymphocytic Lymphoma

Other: Cytology Specimen Collection Procedure

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 Design

• Study Type: Observational
• Actual Enrollment: 174 participants
• Official Title: Rare And Cutaneous Non-Hodgkin Lymphoma Registry
• Actual Study Start Date: May 30, 2005
• Actual Primary Completion Date: June 1, 2007

Groups and Cohorts

Group/Cohort	Intervention/treatment
Observational (specimen collection); See Detailed Description	Other: Cytology Specimen Collection Procedure; Correlative studies; Other Name: Cytologic Sampling

Outcome Measures

Primary Outcome Measures :

1. Clinical features, treatment, and outcomes [ Time Frame: Up to 5 years ]
2. Pathologic and biologic features of these diseases, including molecular diagnostics and flow cytometry [ Time Frame: Up to 5 years ]
3. 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 ]
4. Sub-groups of these diseases that could be targeted for future biologic, pathologic, or therapeutic studies [ Time Frame: Up to 5 years ]

Eligibility Criteria

• Ages Eligible for Study: up to 21 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

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

Contacts and Locations

  Show 130 Study Locations

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Amanda Termuhlen; Children's Oncology Group

More Information

• Responsible Party: Children's Oncology Group
• ClinicalTrials.gov Identifier: NCT01000753 History of Changes
• Other Study ID Numbers: ANHL04B1; NCI-2009-00406 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); COG-ANHL04B1; CDR0000404164; ANHL04B1 ( Other Identifier: Childrens Oncology Group ); ANHL04B1 ( Other Identifier: CTEP ); U10CA098543 ( U.S. NIH Grant/Contract ); UG1CA189958 ( U.S. NIH Grant/Contract )
• First Posted: October 23, 2009
• Last Update Posted: August 7, 2018
• Last Verified: December 2017

Additional relevant MeSH terms:

Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, T-Cell; Lymphoma, T-Cell, Cutaneous; Lymphoma, B-Cell; Lymphoproliferative Disorders; Plasmablastic Lymphoma; Lymphoma, Large-Cell, Immunoblastic; Neoplasms by Histologic Type; Neoplasms; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Lymphoma, Large B-Cell, Diffuse