Studying Biomarkers in Samples From Patients With High-Risk Neuroblastoma

Neuroblastoma Clinical Trial

Official title:

Alternative Lengthening of Telomeres (ALT) in Neuroblastoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510600
• Other study ID #: ANBL12B5
• Secondary ID: COG-ANBL12B5CDR0
• Status: Completed
• Phase: N/A
• First received: January 11, 2012
• Last updated: May 17, 2016
• Start date: January 2012
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Genetic:
• DNA analysis

• polymerase chain reaction

Other:
• laboratory biomarker analysis

• medical chart review

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sensitivity and specificity, as well as the optimal cut-off, for telomere length (TL) qPCR as an ALT detection method			No
Primary	Frequency and characteristics of ALT in high-risk NB			No
Primary	C-circle level as a marker of ALT activity in NB			No
Primary	Prognostic value of ALT			No
Primary	C-circle assay utility in detecting tumor DNA in the serum of NB patients with an ALT			No