SarcomaGENEWINGNCT01210209
Study of Blood Samples From Patients With Ewing Sarcoma and Their Relatives
An observational study of Sarcoma, run by Institut Curie at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcoma
- What is being tested?
- genome-wide association study
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2010to Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with Ewing's sarcoma, with idenfication of a specific translocation of Ewing's sarcoma
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GENEWING - A Genome Wide Association Study in Ewing Sarcoma
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.
Read the 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.
- Conditions
- Sarcoma
- Being tested
- genome-wide association study
- Keywords
- Ewing sarcoma, Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET)
- Medical subject headings
- Sarcoma, Sarcoma, Ewing, Neuroectodermal Tumors, Primitive, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genome-wide association studyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification and characterization of susceptibility genes in patients with Ewing sarcoma
Identification and characterization of susceptibility genes in patients with Ewing sarcoma
Measured: Through study completion, an average of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study start7 Jan 2010
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Retrospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Delattre, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210209
- Sponsor's protocol ID
- IC 2009-02
- Other IDs
- CLCC-IC-2009-02, 2009-A00558-49, EU-21064
- Acronym
- GENEWING
- Status last verified
- May 2021
- First submitted
- 25 Sep 2010
- Last updated
- 19 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GENEWING - A Genome Wide Association Study in Ewing Sarcoma
- ClinicalTrials.gov ID
- NCT01210209
- Acronym / sponsor ID
- GENEWING / IC 2009-02
- Conditions
- Sarcoma
- Keywords
- Ewing sarcoma, Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 7 Jan 2010 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 28 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Family based
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Ewing's sarcoma, with idenfication of a specific translocation of Ewing's sarcoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genome-wide association study | Other | – |
Primary outcome
Identification and characterization of susceptibility genes in patients with Ewing sarcoma
Time frame: Through study completion, an average of 10 years
Identification and characterization of susceptibility genes in patients with Ewing sarcoma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- InCaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Delattre, MD principal investigator
Institut Curie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma, run by Institut Curie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification and characterization of susceptibility genes in patients with Ewing sarcoma (time frame: Through study completion, an average of 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.