NCT01496573

Brief Summary

This research trial studies biomarkers in tumor tissue samples from younger patients with rhabdomyosarcoma. Studying samples of 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2011

Longer than P75 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

December 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 21, 2011

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

4.4 years

First QC Date

December 16, 2011

Last Update Submit

May 17, 2016

Conditions

Alveolar Childhood RhabdomyosarcomaChildhood RhabdomyosarcomaEmbryonal Childhood Rhabdomyosarcoma

Outcome Measures

Primary Outcomes (1)

  • CRKL expression at the protein level

    1 month

Study Arms (1)

Basic science (biomarker analysis)

Archived tumor tissue samples are analyzed for CRKL expression.

Other: laboratory biomarker analysis

Interventions

laboratory biomarker analysisOTHER

Correlative studies

Basic science (biomarker analysis)

Eligibility Criteria

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

Alveolar rhabdomyosarcoma and embryonal rhabdomyosarcoma

You may qualify if:

  • Alveolar rhabdomyosarcoma and embryonal rhabdomyosarcoma specimens from the Children Oncology Group (COG) tumor microarrays (TMAs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Monrovia, California, 91006-3776, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

tumor tissue

Study Officials

  • Lee Helman, 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

December 16, 2011

First Posted

December 21, 2011

Study Start

December 1, 2011

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 19, 2016

Record last verified: 2016-05

Locations

US(1)