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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01000753




Registration number
NCT01000753
Ethics application status
Date submitted
22/10/2009
Date registered
23/10/2009
Date last updated
3/10/2023

Titles & IDs
Public title
Collecting and Storing Tissue Samples From Patients With Rare or Cutaneous Non-Hodgkin Lymphoma
Scientific title
Rare And Cutaneous Non-Hodgkin Lymphoma Registry
Secondary ID [1] 0 0
NCI-2009-00406
Secondary ID [2] 0 0
ANHL04B1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adult Immunoblastic Lymphoma 0 0
Central Nervous System Non-Hodgkin Lymphoma 0 0
Childhood Immunoblastic Lymphoma 0 0
Grade 1 Follicular Lymphoma 0 0
Grade 2 Follicular Lymphoma 0 0
Grade 3 Follicular Lymphoma 0 0
Lymphoproliferative Disorder 0 0
Mantle Cell Lymphoma 0 0
Marginal Zone Lymphoma 0 0
Non-Hodgkin Lymphoma 0 0
Primary Cutaneous B-Cell Non-Hodgkin Lymphoma 0 0
Primary Cutaneous T-Cell Non-Hodgkin Lymphoma 0 0
Small Lymphocytic Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Cytology Specimen Collection Procedure

Observational (specimen collection) - See Detailed Description


Other interventions: Cytology Specimen Collection Procedure
Correlative studies
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical features, treatment, and outcomes
Timepoint [1] 0 0
Up to 5 years
Primary outcome [2] 0 0
Pathologic and biologic features of these diseases, including molecular diagnostics and flow cytometry
Timepoint [2] 0 0
Up to 5 years
Primary outcome [3] 0 0
Establishment of a bank of these pathologically reviewed diseases and make specimens of blood and tissue available to qualified researchers
Timepoint [3] 0 0
Up to 5 years
Primary outcome [4] 0 0
Sub-groups of these diseases that could be targeted for future biologic, pathologic, or therapeutic studies
Timepoint [4] 0 0
Up to 5 years

Eligibility
Key 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
Minimum age
No limit
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/05/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2023
Sample size
Target
Accrual to date
Final
174
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Delaware
Country [8] 0 0
United States of America
State/province [8] 0 0
District of Columbia
Country [9] 0 0
United States of America
State/province [9] 0 0
Florida
Country [10] 0 0
United States of America
State/province [10] 0 0
Georgia
Country [11] 0 0
United States of America
State/province [11] 0 0
Illinois
Country [12] 0 0
United States of America
State/province [12] 0 0
Indiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Iowa
Country [14] 0 0
United States of America
State/province [14] 0 0
Kansas
Country [15] 0 0
United States of America
State/province [15] 0 0
Kentucky
Country [16] 0 0
United States of America
State/province [16] 0 0
Louisiana
Country [17] 0 0
United States of America
State/province [17] 0 0
Maine
Country [18] 0 0
United States of America
State/province [18] 0 0
Maryland
Country [19] 0 0
United States of America
State/province [19] 0 0
Massachusetts
Country [20] 0 0
United States of America
State/province [20] 0 0
Michigan
Country [21] 0 0
United States of America
State/province [21] 0 0
Minnesota
Country [22] 0 0
United States of America
State/province [22] 0 0
Mississippi
Country [23] 0 0
United States of America
State/province [23] 0 0
Missouri
Country [24] 0 0
United States of America
State/province [24] 0 0
Nebraska
Country [25] 0 0
United States of America
State/province [25] 0 0
Nevada
Country [26] 0 0
United States of America
State/province [26] 0 0
New Hampshire
Country [27] 0 0
United States of America
State/province [27] 0 0
New Jersey
Country [28] 0 0
United States of America
State/province [28] 0 0
New York
Country [29] 0 0
United States of America
State/province [29] 0 0
North Carolina
Country [30] 0 0
United States of America
State/province [30] 0 0
Ohio
Country [31] 0 0
United States of America
State/province [31] 0 0
Oklahoma
Country [32] 0 0
United States of America
State/province [32] 0 0
Oregon
Country [33] 0 0
United States of America
State/province [33] 0 0
Pennsylvania
Country [34] 0 0
United States of America
State/province [34] 0 0
South Carolina
Country [35] 0 0
United States of America
State/province [35] 0 0
Tennessee
Country [36] 0 0
United States of America
State/province [36] 0 0
Texas
Country [37] 0 0
United States of America
State/province [37] 0 0
Utah
Country [38] 0 0
United States of America
State/province [38] 0 0
Virginia
Country [39] 0 0
United States of America
State/province [39] 0 0
Washington
Country [40] 0 0
United States of America
State/province [40] 0 0
West Virginia
Country [41] 0 0
United States of America
State/province [41] 0 0
Wisconsin
Country [42] 0 0
Canada
State/province [42] 0 0
Alberta
Country [43] 0 0
Canada
State/province [43] 0 0
British Columbia
Country [44] 0 0
Canada
State/province [44] 0 0
Manitoba
Country [45] 0 0
Canada
State/province [45] 0 0
Nova Scotia
Country [46] 0 0
Canada
State/province [46] 0 0
Ontario
Country [47] 0 0
Canada
State/province [47] 0 0
Quebec
Country [48] 0 0
Canada
State/province [48] 0 0
Saskatchewan
Country [49] 0 0
Puerto Rico
State/province [49] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01000753
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amanda M Termuhlen
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01000753