Studying Biomarkers in Samples From Patients With High-Ri... | NCT01510600

Studies
Studying Biomarkers in Samples From Patients With High-Risk Neuroblastoma

NCT01510600

Sponsor

Children's Oncology Group

Status

Completed

Last Update Posted

May 19, 2016Estimated

Enrollment

99Estimated

Phase

Not provided

Conditions

Neuroblastoma

Interventions

DNA analysis
polymerase chain reaction
laboratory biomarker analysis
medical chart review

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
COG-ANBL12B5	Other Identifier	Children's Oncology Group
CDR0000722061	Other Identifier	Clinical Trials.gov
ANBL12B5	Other Identifier	Children's Oncology Group
NCI-2012-00109	Registry Identifier	CTRP (Clinical Trial Reporting Program)

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Jan 11, 2012

First Submission Date that Met QC Criteria

Jan 11, 2012

First Posted Date

Jan 16, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2016

Last Update Posted Date

May 19, 2016Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

99Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The sensitivity and specificity, as well as the optimal cut-off, for telomere length (TL) qPCR as an ALT detection method
Frequency and characteristics of ALT in high-risk NB
C-circle level as a marker of ALT activity in NB
Prognostic value of ALT
C-circle assay utility in detecting tumor DNA in the serum of NB patients with an ALT

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

Patients diagnosed with neuroblastoma.

Sampling Method

Non-Probability Sample

ID	Term
D018241	Neuroectodermal Tumors, Primitive, Peripheral
D018242	Neuroectodermal Tumors, Primitive
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors

ID	Term
D021141	Nucleic Acid Amplification Techniques
D005821	Genetic Techniques
D008919	Investigative Techniques

Name	Type	Description	Arm Group Labels	Other Names
DNA analysis	Genetic
polymerase chain reaction	Genetic
laboratory biomarker analysis	Other
medical chart review	Other