Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any - 99 |
| Updated: | 4/6/2019 |
| Start Date: | April 19, 2010 |
| Contact: | Donna M Bernstein, R.N. |
| Email: | db302w@nih.gov |
| Phone: | (240) 760-6189 |
Background:
- Laboratory investigators who are studying common childhood cancers are interested in
developing a tissue repository to collect and store blood, serum, tissue, urine, or tumors of
children who have cancer or adults who have common childhood cancers. To develop this
repository, additional samples will be collected from children and adults who have been
diagnosed with common childhood cancers such as leukemia and tumors of the central nervous
system.
Objectives:
- To collect and store blood, serum, tissue, urine, or tumor samples of children who have
cancer or adults who have common childhood cancers.
Eligibility:
- Individuals who have been diagnosed with a common childhood cancer (e.g., leukemia)
regardless of patient age.
- Children, adolescents, and adults who have been diagnosed with a type of cancer more
commonly found in adults.
Design:
- Extra blood, serum (the liquid part of blood), tissue, urine, or tumor samples will be
collected from participants at a time when sampling is required for medical care or as
part of a research study.
- No additional procedures will be performed for the sole purpose of obtaining additional
tumor tissue, aside from what is required for clinical care.
- Laboratory investigators who are studying common childhood cancers are interested in
developing a tissue repository to collect and store blood, serum, tissue, urine, or tumors of
children who have cancer or adults who have common childhood cancers. To develop this
repository, additional samples will be collected from children and adults who have been
diagnosed with common childhood cancers such as leukemia and tumors of the central nervous
system.
Objectives:
- To collect and store blood, serum, tissue, urine, or tumor samples of children who have
cancer or adults who have common childhood cancers.
Eligibility:
- Individuals who have been diagnosed with a common childhood cancer (e.g., leukemia)
regardless of patient age.
- Children, adolescents, and adults who have been diagnosed with a type of cancer more
commonly found in adults.
Design:
- Extra blood, serum (the liquid part of blood), tissue, urine, or tumor samples will be
collected from participants at a time when sampling is required for medical care or as
part of a research study.
- No additional procedures will be performed for the sole purpose of obtaining additional
tumor tissue, aside from what is required for clinical care.
Background:
-Laboratory-based investigations have contributed to an improved understanding of the biology
of cancer and to the development of new therapies for pediatric malignancies.
Objectives:
-Systematic Molecular, Genomic, Proteomic, Metabolomic ( Omic ) and other profiling for
enrolled subjects.
Eligibility:
Pediatric or Adult subjects of any age with one of the following:
- Diagnosis of any tumor or malignancy, pre-malignant disorder or suspected cancer
susceptibility familial syndromes, regardless of age
- Individuals without malignancy undergoing surgery, other treatment or normal well visit.
- Biological relatives of a subject with a pediatric tumor or malignancy or with suspected
familial cancer syndrome.
- Biological relatives of a subject with a tumor or malignancy (pediatric or adult) or
with suspected familial cancer syndrome.
- Patients enrolled in an approved companion protocol
- Blood and/or tissue specimens that have been previously collected and are available for
research analysis
- Biospecimens can be collected with minimal additional risk to the subject during
sampling or procedures required for routine patient care.
Design:
- This study will allow for the collection of specimens for a Tissue Repository, and for
designated sample investigations including systematic molecular, genomic and proteomic
(Omic) profiling, and growth factor and cellular profile investigations.
- Testing activities may include:
- DNA, RNA and protein will be extracted from a section of tumor samples, the
remainder will be stored.
- Germ line DNA and RNA will be extracted from lymphocytes or other normal uninvolved
tissue
- Germ line DNA will be extracted from lymphocytes or other normal uninvolved tissue
of the biological relatives of the subject.
- Xenografts and cell lines will be established from tumor samples
- Tumor samples and samples for circulating tumor cells sent for the establishment of
Xenografts and single cell suspension of tumor for drug testing
- Omics (Genomics and Proteomic) studies will be performed
- Growth factor and cellular profile investigations of bone marrow-derived cell
populations to include quantification of hematopietic progenitor cells (HPCs),
endothelial progenitor cells (EPCs), and mesenchymal progenitor cells (MPCs),
levels of matrix metalloprotease 2 and 9 (MMP2) and (MMP9), gene expression, growth
factor and microvesicle analysis and bone marrow analysis of progenitor cells in
blood and tissue.
- Research tests described in active IRB approved protocols
- Immune profiling and stromal profiling of blood, tumor, and normal tissues
- Immune function studies from blood and normal tumor tissues
- Utilizing an oversight committee to oversee the receipt and the distribution of unlinked
tissues to other investigators.
- Qualitative methodologies will be used to ascertain knowledge, attitudes, beliefs, and
behaviors in 25-35 parents/caregivers at NIH concerning the anticipated use of NGS for
diagnosing and directing therapy for pediatric cancer and how incidental findings might
be returned.
- Expected accrual 1000-150 patients per year.
-Laboratory-based investigations have contributed to an improved understanding of the biology
of cancer and to the development of new therapies for pediatric malignancies.
Objectives:
-Systematic Molecular, Genomic, Proteomic, Metabolomic ( Omic ) and other profiling for
enrolled subjects.
Eligibility:
Pediatric or Adult subjects of any age with one of the following:
- Diagnosis of any tumor or malignancy, pre-malignant disorder or suspected cancer
susceptibility familial syndromes, regardless of age
- Individuals without malignancy undergoing surgery, other treatment or normal well visit.
- Biological relatives of a subject with a pediatric tumor or malignancy or with suspected
familial cancer syndrome.
- Biological relatives of a subject with a tumor or malignancy (pediatric or adult) or
with suspected familial cancer syndrome.
- Patients enrolled in an approved companion protocol
- Blood and/or tissue specimens that have been previously collected and are available for
research analysis
- Biospecimens can be collected with minimal additional risk to the subject during
sampling or procedures required for routine patient care.
Design:
- This study will allow for the collection of specimens for a Tissue Repository, and for
designated sample investigations including systematic molecular, genomic and proteomic
(Omic) profiling, and growth factor and cellular profile investigations.
- Testing activities may include:
- DNA, RNA and protein will be extracted from a section of tumor samples, the
remainder will be stored.
- Germ line DNA and RNA will be extracted from lymphocytes or other normal uninvolved
tissue
- Germ line DNA will be extracted from lymphocytes or other normal uninvolved tissue
of the biological relatives of the subject.
- Xenografts and cell lines will be established from tumor samples
- Tumor samples and samples for circulating tumor cells sent for the establishment of
Xenografts and single cell suspension of tumor for drug testing
- Omics (Genomics and Proteomic) studies will be performed
- Growth factor and cellular profile investigations of bone marrow-derived cell
populations to include quantification of hematopietic progenitor cells (HPCs),
endothelial progenitor cells (EPCs), and mesenchymal progenitor cells (MPCs),
levels of matrix metalloprotease 2 and 9 (MMP2) and (MMP9), gene expression, growth
factor and microvesicle analysis and bone marrow analysis of progenitor cells in
blood and tissue.
- Research tests described in active IRB approved protocols
- Immune profiling and stromal profiling of blood, tumor, and normal tissues
- Immune function studies from blood and normal tumor tissues
- Utilizing an oversight committee to oversee the receipt and the distribution of unlinked
tissues to other investigators.
- Qualitative methodologies will be used to ascertain knowledge, attitudes, beliefs, and
behaviors in 25-35 parents/caregivers at NIH concerning the anticipated use of NGS for
diagnosing and directing therapy for pediatric cancer and how incidental findings might
be returned.
- Expected accrual 1000-150 patients per year.
- SUBJECT INCLUSION CRITERIA:
Pediatric or adult subjects with one of the following:
- Diagnosis of any tumor, malignancy, pre-malignant disorder, or suspected premalignant
familial syndromes, regardless, of patient age;
- Biological relatives of any patients with tumor, malignancy, premalignant disorder, or
suspected familial pre-malignant syndrome, regardless of patient age or the diagnosis
of an adult malignancy or pre-malignant disorder;
- Healthy Volunteer without history of malignancy nor a family member currently being
treated for cancer who are undergoing surgery, treatment or during well visits;
- Biospecimens can be collected with minimal additional risk to the subject during
sampling or procedures required for routine patient care.
- Human samples, specimens and data collected on IRB approved protocols that are now
closed
- Subjects greater than or equal to 18 or parent/guardian or Legally Authorized
Representative (LAR) of children less than or equal to 18 must have be willing to sign
an IRB-approved informed consent document that permits the use of the tumor and other
samples for genomic-based molecular characterization projects.
Inclusion Criteria for Social and Behavioral Outcome Interviews:
- Parent/caregiver of a participating pediatric or adult patient who is being treated
for, or who has previously been treated for any form of pediatric cancer.
- Must be able to give consent and sign the informed consent document.
- Able to understand the English language.
EXCLUSION CRITERIA:
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: (888) NCI-1937
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