Clinical trial NCT00588068: Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome
Official title: Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuroblastoma
Keywords: Adrenal Gland
No stage requirement
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Southern Illinois University
name: Spanish National Cancer Center
name: St. Jude Children's Research Hospital
name: Washington University School of Medicine
name: University of Texas
name: Weill Medical College of Cornell University
First posted: 2008-01-08
Enrollment: 2070
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be offered participation in this study by their attending oncologist in the Department of Pediatrics at Memorial Sloan Kettering Cancer Center.

Brief summary: The purpose of this study is to find out the genetic and biochemical makeup of your neuroblastic tumor, which influences its aggressiveness and the suitable therapy. These research studies include surface marker analysis, cytogenetics, cancer genes,genome sequencing, tumor growth-related genes and tumor growth in test tubes. Your blood, marrow, and hematopoietic stem cell samples will also be tested for tumors or leukemia cells, and your serum tested for anti-tumor antibodies.

Detailed description: To collect tumor, marrow specimens prospectively to study the molecular-genetic makeup of individual neuroblastic tumor and its metastasis by blood and marrow, and to correlate these findings with clinical outcome, and to relate the signaling circuitry of neuroblastic tumors to that of embryonic neuroectodermal cells. .

Eligibility criteria: Inclusion Criteria:

* Neuroblastic tumors diagnosed in accordance with the International Neuroblastoma Staging System

OR

* Clinically suspected neuroblastic tumors.

PK DRAW INCLUSION CRITERIA (FOR PK DRAWS ONLY):

PK Draw Inclusion Criteria

* Patients who receive naxitamab as part of their standard of care

Exclusion Criteria:

* None

Primary outcomes:
measure: To study the molecular-genetic makeup and metastasis of neuroblastic tumors.
timeFrame: 2 years
Secondary outcomes:
measure: To study the correlation of these biologic markers with clinical outcome.
timeFrame: 2 years
measure: To relate neuroblastic tumor and embryonic neuroectodermal cell circuitry.
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Nai-Kong Cheung, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Felix CA, Slater DJ, Davenport JW, Yu X, Gregory BD, Li MM, Rappaport EF, Cheung NV. KMT2A-MAML2 rearrangement emerged and regressed during neuroblastoma therapy without leukemia after 12.8-year follow-up. Pediatr Blood Cancer. 2022 Jan;69(1):e29344. doi: 10.1002/pbc.29344. Epub 2021 Sep 22.
citation: Cheung NK, Zhang J, Lu C, Parker M, Bahrami A, Tickoo SK, Heguy A, Pappo AS, Federico S, Dalton J, Cheung IY, Ding L, Fulton R, Wang J, Chen X, Becksfort J, Wu J, Billups CA, Ellison D, Mardis ER, Wilson RK, Downing JR, Dyer MA; St Jude Children's Research Hospital-Washington University Pediatric Cancer Genome Project. Association of age at diagnosis and genetic mutations in patients with neuroblastoma. JAMA. 2012 Mar 14;307(10):1062-71. doi: 10.1001/jama.2012.228.