NCT01626170

Brief Summary

This laboratory study is looking into mechanisms of radiation therapy resistance in samples from younger patients with rhabdomyosarcoma. Studying samples of 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. It may also help doctors find better ways to treat cancer

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

1.3 years

First QC Date

June 20, 2012

Last Update Submit

July 13, 2016

Conditions

Alveolar Childhood RhabdomyosarcomaEmbryonal Childhood RhabdomyosarcomaPreviously Treated Childhood RhabdomyosarcomaPreviously Untreated Childhood RhabdomyosarcomaRecurrent Childhood Rhabdomyosarcoma

Outcome Measures

Primary Outcomes (2)

  • Molecular response

    Up to 1 year

  • Novel pathway/biomarkers detected within clinically annotated patient tumor tissue samples

    Up to 1 year

Study Arms (1)

Correlative (laboratory biomarker analysis)

Archived tissue samples of matched primary-relapsed and non-matched primary are analyzed for genomic DNA, DNA methylation profiles, RNA sequencing, differences between alveolar rhabdomyosarcoma (ARMS) and embryonal rhabdomyosarcoma (ERMS), gene expression profiles, target-of-rapamycin complex 1 (TORC1) and TORC2 pathway intermediates, and paired box 3 (PAX3)/forkhead box O1 (FOXO1) translocation by microarray, immunohistochemical staining, and fluorescence in situ hybridization (FISH).

Other: laboratory biomarker analysis

Interventions

laboratory biomarker analysisOTHER

Correlative studies

Correlative (laboratory biomarker analysis)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with rhabdomyosarcoma enrolled on COG-D9902.

You may qualify if:

  • Tissues requested from the Children Oncology Group (COG) sarcoma banking protocol COG-D9902
  • All subtypes of rhabdomyosarcoma specimens
  • Matched primary-relapsed specimens (from same patient, separated by time):
  • Frozen tissue if available
  • Scrolls of formalin-fixed paraffin-embedded tissue (if frozen not available)
  • unstained formalin-fixed paraffin-embedded thin sections
  • All other general (primary or relapsed) cases
  • unstained formalin-fixed paraffin-embedded thin sections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Monrovia, California, 91006-3776, United States

Location

Study Officials

  • Christopher Pelloski, MD

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2012

First Posted

June 22, 2012

Study Start

June 1, 2012

Primary Completion

October 1, 2013

Last Updated

July 14, 2016

Record last verified: 2016-07

Locations

US(1)