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OpenTrials
Completed

NCT Number: NCT01000753

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cytology Specimen Collection Procedure

Other

Correlative studies

Other names: Cytologic Sampling

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Rare And Cutaneous Non-Hodgkin Lymphoma Registry

Important dates

Study start
2005
Primary completion
2007
Study completion
2023
First posted
Oct 23, 2009
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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