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

• ClinicalTrials.gov Identifier: NCT01000753
• Recruitment Status: Active, not recruiting
• First Posted: October 23, 2009
• Last Update Posted: March 24, 2021
• Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Children's Oncology Group

Tracking Information

• First Submitted Date: October 22, 2009
• First Posted Date: October 23, 2009
• Last Update Posted Date: March 24, 2021
• Actual Study Start Date: May 30, 2005
• Actual Primary Completion Date: June 1, 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 3, 2018)

• Clinical features, treatment, and outcomes [ 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 ]
• Sub-groups of these diseases that could be targeted for future biologic, pathologic, or therapeutic studies [ Time Frame: Up to 5 years ]

Original Primary Outcome Measures (submitted: October 22, 2009)

• Clinical features, treatment, and outcomes
• Pathologic and biologic features of these diseases, including molecular diagnostics and flow cytometry
• Establishment of a bank of these pathologically reviewed diseases and make specimens of blood and tissue available to qualified researchers
• Sub-groups of these diseases that could be targeted for future biologic, pathologic, or therapeutic studies

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Collecting and Storing Tissue Samples From Patients With Rare or Cutaneous Non-Hodgkin Lymphoma
• Official Title: Rare And Cutaneous Non-Hodgkin Lymphoma Registry
• 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.

• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

Tumor tissue, bone marrow, blood, CSF, or sera specimens

• Sampling Method: Non-Probability Sample
• Study Population: PATIENTS WITH RARE OR CUTANEOUS NHL

Condition

• 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

Intervention

Other: Cytology Specimen Collection Procedure

Correlative studies

Other Name: Cytologic Sampling

Study Groups/Cohorts

Observational (specimen collection)

See Detailed Description

Intervention: Other: Cytology Specimen Collection Procedure

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: August 3, 2018): 174
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Actual Primary Completion Date: June 1, 2007 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 21 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Canada, Puerto Rico, United States

Administrative Information

• NCT Number: NCT01000753
• 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 )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Children's Oncology Group
• Study Sponsor: Children's Oncology Group
• Collaborators: National Cancer Institute (NCI)

Investigators

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

• PRS Account: Children's Oncology Group
• Verification Date: March 2021