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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 : March 24, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Tracking Information
First Submitted Date October 22, 2009
First Posted Date October 23, 2009
Last Update Posted Date March 24, 2021
Actual Study Start Date May 30, 2005
Actual Primary Completion Date June 1, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 3, 2018)
  • 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 ]
Original Primary Outcome Measures
 (submitted: October 22, 2009)
  • 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
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Collecting and Storing Tissue Samples From Patients With Rare or Cutaneous Non-Hodgkin Lymphoma
Official Title Rare And Cutaneous Non-Hodgkin Lymphoma Registry
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.
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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Tumor tissue, bone marrow, blood, CSF, or sera specimens
Sampling Method Non-Probability Sample
Study Population PATIENTS WITH RARE OR CUTANEOUS NHL
Condition
  • 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
Intervention Other: Cytology Specimen Collection Procedure
Correlative studies
Other Name: Cytologic Sampling
Study Groups/Cohorts Observational (specimen collection)
See Detailed Description
Intervention: Other: Cytology Specimen Collection Procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: August 3, 2018)
174
Original Enrollment Not Provided
Study Completion Date Not Provided
Actual Primary Completion Date June 1, 2007   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Canada,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01000753
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 )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Children's Oncology Group
Study Sponsor Children's Oncology Group
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Amanda M Termuhlen Children's Oncology Group
PRS Account Children's Oncology Group
Verification Date March 2021