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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01000753
First received: October 22, 2009
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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 Intervention
Lymphoma
Lymphoproliferative Disorder
Other: biologic sample preservation procedure
Other: informational intervention

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Rare And Cutaneous Non-Hodgkin Lymphoma Registry

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Clinical features, treatment, and outcomes [ Time Frame: length of study ] [ Designated as safety issue: No ]
  • Pathologic and biologic features of these diseases, including molecular diagnostics and flow cytometry [ Time Frame: length of study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Sub-groups of these diseases that could be targeted for future biologic, pathologic, or therapeutic studies [ Time Frame: length of study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

tumor tissue, bone marrow, blood


Estimated Enrollment: 250
Study Start Date: May 2005
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

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

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with non-Hodgkin lymphoma (NHL)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01000753

  Show 108 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Amanda M. Termuhlen, MD Nationwide Children's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01000753     History of Changes
Other Study ID Numbers: ANHL04B1, COG-ANHL04B1, CDR0000404164
Study First Received: October 22, 2009
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Oncology Group:
adult diffuse small cleaved cell lymphoma
adult diffuse mixed cell lymphoma
grade 1 follicular lymphoma
grade 2 follicular lymphoma
grade 3 follicular lymphoma
childhood immunoblastic large cell lymphoma
adult immunoblastic large cell lymphoma
mantle cell lymphoma
marginal zone lymphoma
small lymphocytic lymphoma
primary central nervous system non-Hodgkin lymphoma
cutaneous B-cell non-Hodgkin lymphoma
cutaneous T-cell non-Hodgkin lymphoma
lymphoproliferative disorder

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 22, 2014