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Molecular Analysis Of Solid Tumors


N/A
N/A
25 Years
Open (Enrolling)
Both
Pediatric Solid Tumors

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Trial Information

Molecular Analysis Of Solid Tumors


Each year approximately 2,200 children in the United States are diagnosed with
neuroblastoma, osteosarcoma, Ewing sarcoma family of tumors (ESFT), retinoblastoma and soft
tissue sarcomas. These aggressive pediatric solid tumors are developmental tumors that
initiate during periods of tissue growth and morphogenesis in the neural crest, bone and
soft tissues. The overall survival rate of these tumors in the advanced stage is less than
30%. Despite intensive efforts over the past three decades using multiple therapeutic
modalities including chemotherapy, surgery, radiation, autologous bone marrow transplant and
biological agents there has been modest improvement in the long-term survival of these
advanced stage pediatric solid tumors. A better understanding of the molecular, cellular and
genetic changes that occur in the developing tissues as tumors form could improve the
treatment of these devastating cancers. In particular, chemotherapeutic agents may be more
effectively targeted to key regulatory enzymes or proteins if the study had a better
understanding of the pathways that are disrupted as cells progress from preneoplastic
lesions to metastatic disease. The specific aim of this proposal is to identify the changes
in gene expression that occur in neuroblastoma, retinoblastoma, osteosarcoma, Ewing sarcoma
family of tumors [ESFT] and soft tissue sarcoma cells and to correlate these changes with
genetic and cellular changes in the tumor cells. [RNA] ribonucleic acid and genomic [DNA]
deoxyribonucleic acid will be isolated from neuroblastoma, retinoblastoma, osteosarcoma,
ESFT [Ewing sarcoma family of tumors] and soft tissue sarcomas (both primary and metastatic
lesions) following surgery or bone marrow aspiration of previously untreated patients.
Additional testing will be conducted on tumor samples at any point during or following
therapy in which a surgical specimen is obtained. When there is sufficient tumor sample
remaining after pathological analysis and banking, fresh primary tumor cells will be used to
prepare orthotopic xenografts and to establish models of each disease that recapitulate the
advanced forms of neuroblastoma, osteosarcoma, Ewing sarcoma family of tumors [ESFT],
retinoblastoma and soft tissue sarcomas. For a small group of these excess samples, this
study will perform fixation for electron microscopy and process the samples for [TEM]
transmission electron microscopy analysis. These studies will complement our active research
program characterizing the molecular, cellular and genetic features of genetically
engineered mouse models of each of these diseases. Biological samples from the cohort of
patients treated at St. Jude Children's Research Hospital will be complemented with samples
collected and processed by collaborating institutions around the world. Samples collected
from international collaborators will be used for analysis of [DNA] deoxyribonucleic acid
and [RNA] ribonucleic acid to complement the St. Jude Children's Research Hospital cohort.
Through this collaboration the study anticipates that they will be able to obtain enough
fresh tumor samples to improve their understanding of multistage tumorigenesis in pediatric
solid malignancies.


Inclusion Criteria:



- Must have a suspected or known diagnosis of neuroblastoma, osteosarcoma, Ewing
sarcoma family of tumor or soft tissue sarcoma based on the initial diagnostic workup
and evidence of gross disease amenable to excision. Specimens may be collected at
some or all of the following time points: initial biopsy, bone marrow aspiration
procedures, tumor resection, and at time of possible relapse.

- Patients with a diagnosis of retinoblastoma based on initial diagnostic workup and
who require enucleation may be enrolled if there is no active therapeutic or biologic
protocol for retinoblastoma.

- The patient or his/her legal guardian, as appropriate, must provide written informed
consent within 7 days of the removal of the tissue/bone marrow/blood sample.

- A separate written informed consent for tissue banking (TBank) must be provided by
the patient or his/her legal guardian, as appropriate, also within 7 days of the
removal of the tissue/bone marrow/blood sample.

- The patient is being seen at St. Jude Children's Research Hospital or at a
collaborating institution.

- Patients must be less than or equal to 25 years old at the time of enrollment.

- Patients must have excess tissue remaining after the specimens have been divided for
diagnostic analysis and tumor banking. This will be determined by the tissue
resources laboratory when samples are collected at the time of diagnosis and/or
possible relapse

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Perform analysis of gene expression profiles. [RNA] ribonucleic acid will be isolated from fresh frozen tumor specimens and hybridized to Affymetrix gene expression arrays.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Sara M. Federico, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

MAST

NCT ID:

NCT01050296

Start Date:

January 2010

Completion Date:

September 2015

Related Keywords:

  • Pediatric Solid Tumors
  • Neuroblastoma
  • Retinoblastoma
  • Osteosarcoma
  • Rhabdomyosarcoma
  • Ewing sarcoma
  • Non-rhabdomyosarcoma soft tissue sarcoma
  • Neoplasms

Name

Location

St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794