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Completed

NCT Number: NCT01510600

Studying Biomarkers in Samples From Patients With High-Risk Neuroblastoma

RATIONALE: Studying samples of blood and tumor tissue 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 biomarkers in samples from patients with high-risk neuroblastoma.

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Key information

About this study

OBJECTIVES:

  • To establish telomere length measurement by quantitative polymerase chain reaction (qPCR) as an alternative lengthening of telomeres (ALT) detection method in neuroblastoma (NB).
  • To determine the frequency of ALT in high-risk NB and the characteristics of ALT+ NB.
  • To establish C-circle (extra-chromosomal telomeric DNA circles) level as a marker of ALT activity in NB.
  • To evaluate the prognostic significance of ALT in NB.
  • To evaluate the utility of the C-circle assay for the detection of circulating tumor DNA in NB patients with an ALT+ tumor.

OUTLINE: Archived tumor tissue and serum samples are analyzed for telomere length measurement, frequency, and C-circle levels by PCR. Results are then compared with patients' age at diagnosis and outcomes including survival data (event-free and overall survival).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Snap-frozen neuroblastoma (NB) tumors collected at diagnosis (Objectives 1 to 3)
  • High-risk stage 3 or 4 NB AND MYCN non-amplified, i.e., exclude stage 4 infants who are not high-risk
  • Up to five high-risk (> 18 months, unfavorable histology) stage 3/MYCN non-amplified tumors
  • Patients preferably treated on protocol COG-A3973 or similar protocols with myeloablative therapy
  • At least 3 years of follow-up for those with no event (current evidence suggests that ALT+ NBs often relapse late, i.e., 2 years or longer from diagnosis)
  • NB tumor DNA collected at diagnosis (Objectives 2 & 3)
  • High-risk stage 3 or 4 NB as for Objective 1, except for MYCN status
  • Stage 4 tumors are preferred; may include up to seven high-risk stage 3 tumors with similar distribution of MYCN-amplified and non-amplified tumors
  • Frozen serum from NB patients (Objective 5; 2nd stage of project)
  • Paired serum obtained at diagnosis from patients with ALT+ or ALT- tumors identified in Objective 2

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Treatment and study plan

DNA analysis

Genetic

polymerase chain reaction

Genetic

laboratory biomarker analysis

Other

medical chart review

Other

Primary outcomes

  1. The sensitivity and specificity, as well as the optimal cut-off, for telomere length (TL) qPCR as an ALT detection method

  2. Frequency and characteristics of ALT in high-risk NB

  3. C-circle level as a marker of ALT activity in NB

  4. Prognostic value of ALT

  5. C-circle assay utility in detecting tumor DNA in the serum of NB patients with an ALT

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Alternative Lengthening of Telomeres (ALT) in Neuroblastoma

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 16, 2012
Registry last updated
May 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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