NCT01668095

Brief Summary

This research trial studies tumor tissue to identify important proteins and biomarkers from patients with rhabdomyosarcoma that has spread to other places in the body and usually cannot be cured or controlled with treatment. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
10

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

August 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

2 months

First QC Date

August 15, 2012

Last Update Submit

May 17, 2016

Conditions

Adult RhabdomyosarcomaChildhood Alveolar RhabdomyosarcomaChildhood Embryonal RhabdomyosarcomaPreviously Treated Childhood RhabdomyosarcomaRecurrent Adult Soft Tissue SarcomaRecurrent Childhood RhabdomyosarcomaStage III Adult Soft Tissue SarcomaStage IV Adult Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

  • Prevalence of the candidate target (Pax3, Pax7, or Patched-1), and whether the candidate target is expressed in the tumor vs stroma

    1 month

Study Arms (1)

Ancillary-Correlative (biomarker analysis)

Immunohistochemistry is performed for each candidate target (Pax3, Pax7, and Patched-1) in each disease (alveolar, embryonal, and anaplastic rhabdomyosarcoma) for tissue microarray analysis.

Other: Laboratory Biomarker Analysis

Interventions

Laboratory Biomarker AnalysisOTHER

Correlative studies

Ancillary-Correlative (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 that has spread to other places in the body and usually cannot be cured or controlled with treatment.

You may qualify if:

  • tissue microarrays (TMA) slides of the following diseases available:
  • Alveolar rhabdomyosarcoma
  • Embryonal rhabdomyosarcoma
  • Anaplastic rhabdomyosarcoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

tumor tissue

MeSH Terms

Conditions

RhabdomyosarcomaSarcoma

Condition Hierarchy (Ancestors)

MyosarcomaNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Charles Keller, MD

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 15, 2012

First Posted

August 17, 2012

Study Start

August 1, 2012

Primary Completion

October 1, 2012

Last Updated

May 18, 2016

Record last verified: 2016-05

Locations

US(1)