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OpenTrials
Completed

NCT Number: NCT01247584

Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia

RATIONALE: Studying bone marrow samples 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 study is studying biomarkers in samples from young patients with acute myeloid leukemia.

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Key information

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

About this study

OBJECTIVES:

  • To compare the frequency of germline telomerase mutations in pediatric patients with acute myeloid leukemia (AML) demonstrating prolonged myelosuppression, defined as ≥ 1 episode > 35 days of neutrophil count recovery after chemotherapy, to the pediatric patients with the expected myelosuppression, defined as consistently < 35 days of neutrophil count recovery after chemotherapy.
  • To assess association between telomerase mutations and incidence of grade 3 or 4 mucositis, relapse, and death.
  • To compare germline (remission) telomere length in pediatric AML patients demonstrating delayed bone marrow recovery with the pediatric patients with consistently expected recovery.
  • To assess whether a correlation between telomere length and incidence of grade 3 or 4 mucositis, relapse, and death exist.

OUTLINE: This is a multicenter study.

Cryopreserved bone marrow samples are analyzed for DNA sequencing and mutation by Sanger-based sequencing methods, quantitative PCR, and SeqMan Pro (Lasergene from DNAStar). Results are then compared with previously published data and existing databases to determine the allele frequency in control populations.

Who can participate

Healthy volunteers accepted: No

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

DISEASE CHARACTERISTICS:

  • Diagnosis of acute myeloid leukemia
  • Enrolled on CCG-2961 and meeting 1 of the following criteria:
  • More than 35 days to recover to an ANC > 500/mm³ after any course of chemotherapy
  • Consistently recovered < 35 days to an ANC > 500/mm³ after all courses of chemotherapy
  • Available cryopreserved cell from diagnostic and end-of-therapy samples

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Treatment and study plan

DNA analysis

Genetic

mutation analysis

Genetic

polymerase chain reaction

Genetic

laboratory biomarker analysis

Other

Primary outcomes

  1. Frequency of mutations

  2. Relapse-free survival

  3. Overall survival

  4. Difference in telomere length

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Telomere Length and Telomerase Mutations in Pediatric Acute Myeloid Leukemia

Important dates

Study start
2010
Primary completion
2016
First posted
Nov 24, 2010
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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