Study of Blood Samples From Patients With Ewing Sarcoma a... | NCT01210209

Studies
Study of Blood Samples From Patients With Ewing Sarcoma and Their Relatives

NCT01210209

Sponsor

Institut Curie

Status

Completed

Last Update Posted

May 19, 2021Actual

Enrollment

350Actual

Phase

Not provided

Conditions

Sarcoma

Interventions

genome-wide association study

Countries

France

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

Status Module

Record Verification Date

May 2021

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 7, 2010Actual

Primary Completion Date

Jul 2019Actual

Completion Date

Jul 2019Actual

First Submitted Date

Sep 25, 2010

First Submission Date that Met QC Criteria

Sep 27, 2010

First Posted Date

Sep 28, 2010Estimated

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 18, 2021

Last Update Posted Date

May 19, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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 in the laboratory from patients with cancer and their relatives may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood samples collected from patients with Ewing sarcoma and their relatives.

Detailed Description

OBJECTIVES:

To identify and characterize a genetic susceptibility factor to Ewing's sarcoma by performing a Genome-Wide Association Study with as many as possible Ewing sarcoma patients.

OUTLINE: This is a multicenter study.

Blood samples are collected from patients and their relatives. Blood DNA samples are analyzed for susceptibility genes of Ewing Sarcoma.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

350Actual

Name	Type	Description	Arm Group Labels	Other Names
genome-wide association study	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Identification and characterization of susceptibility genes in patients with Ewing sarcoma	Identification and characterization of susceptibility genes in patients with Ewing sarcoma	Through study completion, an average of 10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Patients with Ewing sarcoma
Relatives of Ewing sarcoma patients

PATIENT CHARACTERISTICS:

Patients with a fusion genes specific of Ewing Sarcoma

PRIOR CONCURRENT THERAPY:

Not applicable

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

120 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with Ewing's sarcoma, with idenfication of a specific translocation of Ewing's sarcoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olivier Delattre, MD	Institut Curie	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Curie Hopital		Paris		75005	France

Label	URL
InCa	View source

Condition Browse Module

MeSH Terms

ID	Term
D012509	Sarcoma
D012512	Sarcoma, Ewing
D018241	Neuroectodermal Tumors, Primitive, Peripheral

Ancestor Terms

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D012516	Osteosarcoma

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D055106	Genome-Wide Association Study

Ancestor Terms

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017720	Molecular Epidemiology

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
CLCC-IC-2009-02
2009-A00558-49
EU-21064