Clinical trial NCT01510600: Studying Biomarkers in Samples From Patients With High-Risk Neuroblastoma
Official title: Alternative Lengthening of Telomeres (ALT) in Neuroblastoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroblastoma
Keywords: stage 4S neuroblastoma
localized resectable neuroblastoma
localized unresectable neuroblastoma
recurrent neuroblastoma
regional neuroblastoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-01-16
Enrollment: 99
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with neuroblastoma.

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: The sensitivity and specificity, as well as the optimal cut-off, for telomere length (TL) qPCR as an ALT detection method
measure: Frequency and characteristics of ALT in high-risk NB
measure: C-circle level as a marker of ALT activity in NB
measure: Prognostic value of ALT
measure: C-circle assay utility in detecting tumor DNA in the serum of NB patients with an ALT
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sydney Children's Hospitals Network
name: Loretta Lau, MD
role: PRINCIPAL_INVESTIGATOR
References: