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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 : August 7, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

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 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


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




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 ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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


  Show 130 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Amanda Termuhlen Children's Oncology Group

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    Key Record Dates
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