Studying Genes Using Cord Blood and Placenta Samples From Relatively Healthy Newborns and Samples From Younger Patients With Wilms Tumor
This study is ongoing, but not recruiting participants.
Sponsor:
Children's Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01576211
First received: April 11, 2012
Last updated: April 12, 2012
Last verified: April 2012
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Purpose
RATIONALE: Studying samples of blood and tissue from newborns and from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research trial studies cord blood and placenta tissue from newborns, and tumor tissue samples from patients with Wilms tumor.
| Condition | Intervention |
|---|---|
|
Kidney Cancer |
Genetic: DNA methylation analysis Genetic: RNA analysis Genetic: allele-specific oligonucleotide real-time quantitative polymerase chain reaction Genetic: gene expression analysis Genetic: nucleic acid sequencing Genetic: polymorphism analysis Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Official Title: | Investigating the Frequency of Loss of Imprinting Across a Birth Cohort and the Link DNA Methylation Plays |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Frequency of loss of imprinting at birth [ Designated as safety issue: No ]
- Association between methylation levels and gene expression [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- What is the frequency of loss of imprinting at birth (in the cord blood and placenta) in a relatively healthy birth cohort?
- Does deoxyribonucleic acid (DNA) methylation levels at imprinting genes have a direct association to the gene expression?
OUTLINE: Archived tumor tissue, cord blood, and placenta samples are analyzed for DNA methylation, single nucleotide polymorphism, and gene expression by polymerase chain reaction (PCR), pyrosequencing, and quantitative real-time PCR. Information regarding gender and age of the samples are also collected, if possible.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
DISEASE CHARACTERISTICS:
- Wilms tumor tissue samples from Caucasians (fresh or frozen), or DNA and ribonucleic acid (RNA) samples already isolated from patients registered on Children's Oncology Group Wilms tumor protocols
- Normal/control blood samples from matched individuals
- Cord blood/ placenta samples from the Michels lab Epigenetic Birth Cohort
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Peter C. Adamson, Children's Oncology Group - Group Chair Office |
| ClinicalTrials.gov Identifier: | NCT01576211 History of Changes |
| Other Study ID Numbers: | CDR0000730596, COG-AREN12B6 |
| Study First Received: | April 11, 2012 |
| Last Updated: | April 12, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
Wilms tumor and other childhood kidney tumors |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Wilms Tumor Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Neoplasms, Complex and Mixed Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on May 19, 2013