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Protocol Details

Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

10-C-0086

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 4 wk
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Genomics;
Proteomics;
Tissue Repository;
Omics;
Cell Lines;
Natural History

Recruitment Keyword(s)

Pediatric Cancer;
Solid Tumor;
Sarcoma;
Kidney Cancer;
Neuroblastoma

Condition(s)

Sarcoma;
Endocrine Tumors;
Neuroblastoma;
Retinoblastoma;
Renal Cancer

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

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.

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Eligibility

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

--Ability of subject, Legally Authorized Representative (LAR), or parent/legal guardian of children less than or equal to 18 to understand and 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:

None


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Citations:

Linet MS, Ries LA, Smith MA, Tarone RE, Devesa SS. Cancer surveillance series: recent trends in childhood cancer incidence and mortality in the United States. J Natl Cancer Inst. 1999 Jun 16;91(12):1051-8.

Khan J, Bittner ML, Chen Y, Meltzer PS, Trent JM. DNA microarray technology: the anticipated impact on the study of human disease. Biochim Biophys Acta. 1999 Mar 25;1423 (2):M17-28.

Khan J, Saal LH, Bittner ML, Chen Y, Trent JM, Meltzer PS. Expression profiling in cancer using cDNA microarrays. Electrophoresis. 1999 Feb;20(2):223-9.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Rosandra N. Kaplan, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 1-3940
10 CENTER DR
BETHESDA MD 20892
(240) 760-6198
kaplanrn@mail.nih.gov

Donna B. Bernstein, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 1-3750
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6189
bernsted@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937
ncimo_referrals@mail.nih.gov

Clinical Trials Number:

NCT01109394

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