Trial record 1 of 1 for:    ANHL04B1
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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

October 22, 2009
August 5, 2014
May 2005
January 2100   (final data collection date for primary outcome measure)
  • 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 ]
  • Clinical features, treatment, and outcomes [ Designated as safety issue: No ]
  • Pathologic and biologic features of these diseases, including molecular diagnostics and flow cytometry [ 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 [ Designated as safety issue: No ]
  • Sub-groups of these diseases that could be targeted for future biologic, pathologic, or therapeutic studies [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01000753 on ClinicalTrials.gov Archive Site
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Collecting and Storing Tissue Samples From Patients With Rare or Cutaneous Non-Hodgkin Lymphoma
Rare And Cutaneous Non-Hodgkin Lymphoma Registry

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

tumor tissue, bone marrow, blood

Non-Probability Sample

Patients with non-Hodgkin lymphoma (NHL)

  • Lymphoma
  • Lymphoproliferative Disorder
  • Other: biologic sample preservation procedure
  • Other: informational intervention
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.
Interventions:
  • Other: biologic sample preservation procedure
  • Other: informational intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
Not Provided
January 2100   (final data collection date for primary outcome measure)

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
Both
up to 21 Years
No
United States,   Australia,   Canada
 
NCT01000753
ANHL04B1, COG-ANHL04B1, CDR0000404164
No
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Amanda M. Termuhlen, MD Nationwide Children's Hospital
Children's Oncology Group
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP