ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01000753
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

October 22, 2009
October 23, 2009
August 7, 2018
May 30, 2005
June 1, 2007   (Final data collection date for primary outcome measure)
  • 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 ]
  • 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
Complete list of historical versions of study NCT01000753 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Collecting and Storing Tissue Samples From Patients With Rare or Cutaneous Non-Hodgkin Lymphoma
Rare And Cutaneous Non-Hodgkin Lymphoma Registry
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.

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.

Observational
Not Provided
Not Provided
Not Provided
Non-Probability Sample
Not Provided
  • 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
Correlative studies
Other Name: Cytologic Sampling
Observational (specimen collection)
See Detailed Description
Intervention: Other: Cytology Specimen Collection Procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
174
Not Provided
Not Provided
June 1, 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Puerto Rico,   United States
 
 
NCT01000753
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 )
Not Provided
Not Provided
Not Provided
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Amanda Termuhlen Children's Oncology Group
Children's Oncology Group
December 2017