Health TrialsbyHealthPanel

Observational Study on Skeletal Ewing's Sarcoma

ConditionEwing Sarcoma of Bone
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-49
SponsorItalian Sarcoma Group

About this trial

Observational prospective trial aimed to collect the collect demographic, clinical, surgical, pathological and molecular characteristics and treatment from patients affected by skeletal Ewing Sarcoma

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Diagnosis of Ewing's sarcoma of the bone

Diagnosis of Ewing-like sarcoma (round cell sarcoma with fusion of the EWSR1 gene with others not of the ETS family, sarcoma with CIC rearrangement or sarcoma with BCOR rearrangement)

Diagnosis of extraosseous Ewing's sarcoma for patients

Age at diagnosis <50 years

Disqualifiers

None

Trial population

Patients with Ewing's sarcoma of the bone or with Ewing-like sarcoma (round cell sarcoma with fusion of the EWSR1 gene with others not of the Ewings' Tumor Sarcoma family, sarcoma with Capicua Transcriptional Repressor (CIC) rearrangement or sarcoma with BCL6 corepressor (BCOR) rearrangement

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Treatment of Ewings Sarcoma of bone according clinical practice (includes drugs, surgery, radiotherapy or any other received treatments)

    Other intervention

    This observational study collects all the treatments received by the patients according clinical practices or experimental trials and therefore includes drug/biological/surgical/ radiotherapy and any other applicable treatments

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Skeletal Ewing Sarcoma1 intervention

Trial outcomes

Primary outcomes

1

5 years Event Free Survival (EFS)

Onset of any event (an event is the defined as disease recurrence, death for disease or any other cause)

Time frame
5 years

Secondary outcomes

1

Overall Survival (OS)

Time elapsed for the diagnosis to the death for any cause

Time frame
at 5 years
2

Adverse events related to the treatments in patients with age >21 years at the time of diagnosis

Number of Participants of age \>21 years with Treatment-Related Adverse Events as Assessed by CTCAE v5.0,

Time frame
Every 3 weeks (Week 3, week 6, week 9, week 12, ...) up to 30 months
3

To assess baseline clinical and disease-specific factors with possible impact on survival analyses in the subpopulation with Ewing-like sarcoma

Collection of clinical pathological characteristics at disease presentation/diagnosis

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Italian Sarcoma Group

Lead sponsor

Source ClinicalTrials.gov
Apply now