Genomic Profiles Analysis in Children, Adolescents and Young Adult With Sarcomas

NCT ID: NCT04621201

Last Updated: 2023-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-06

Study Completion Date

2026-12-06

Brief Summary

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Bone and soft tissue sarcomas represent about 7-12% of all pediatric cancer and are a heterogeneous group of tumors arising in connective tissues embryologically derived from the mesenchyme. For some of these tumors relapse and mortality rates are still significantly high. Therefore, further studies are needed to better understand pathogenetic processes underlying sarcomas to offer new and more effective treatments. Next generation sequencing (NGS) has opened new frontiers for cancer research allowing to identify somatic or constitutional mutations known or yet unknown with the aim to better understand carcinogenesis. The establishment of the genomic profile of the tumor could also help clinicians to personalize patients treatment based on their genetic and molecular alterations.

Detailed Description

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Conditions

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Diagnosed or Relapsed/Refractory Sarcomas

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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observation and biopsy

biopsy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients with histologically confirmed Osteosarcoma, Ewing Sarcoma or Synovial Sarcoma at first diagnosis.
2. Patients with confirmed relapsed/refractory Osteosarcoma, Ewing Sarcoma or Synovial Sarcoma
3. Written informed consent signed by the patient, or parents or legal representative to perform molecular analysis of the tumor sample.
4. Patients aged ≤24 years
5. Pathological review of tumor samples.
6. Availability of fresh tumor sample from newly diagnosed or relapsed/refractory cancer and 10 ml of EDTA peripheral blood sample. Centralization of paraffin-embedded tumor sample might be optional.

Exclusion Criteria

* 1\. Known history of active HIV, HCV, or HBV infection 2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient undergoing surgery biopsy or the quality of the data.
Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Associazione Italiana Ematologia Oncologia Pediatrica

OTHER

Sponsor Role collaborator

Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

OTHER

Sponsor Role lead

Responsible Party

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Prof. Franca Fagioli

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Franca Fagioli, MD

Role: PRINCIPAL_INVESTIGATOR

A.O.U. Città della Salute e della Scienza

Locations

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AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita

Torino, Turin, Italy

Site Status RECRUITING

Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status RECRUITING

Policlinico S.Orsola-Malpighi

Bologna, , Italy

Site Status RECRUITING

Azienda ospedaliero-universitaria Meyer

Florence, , Italy

Site Status RECRUITING

Istituto Giannina Gaslini

Genova, , Italy

Site Status RECRUITING

Istituto Nazionale Tumori

Milan, , Italy

Site Status RECRUITING

Presidio Ospedaliero Gaetano Pini | ASST Pini-CTO

Milan, , Italy

Site Status SUSPENDED

Fondazione I.R.C.C.S. Policlinico San Matteo

Pavia, , Italy

Site Status RECRUITING

Istituti fisioterapici Ospitalieri - Istituto Tumori Regina Elena e Istituto Dermatologico San Gallicano

Roma, , Italy

Site Status ACTIVE_NOT_RECRUITING

IRCCS materno infantile Burlo Garofolo

Trieste, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Elisa Tirtei, MD

Role: CONTACT

00390113135171

Celeste Cagnazzo, PhD

Role: CONTACT

Facility Contacts

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Celeste Cagnazzo, PhD

Role: primary

00390113135171

Emanuela Palmerini

Role: primary

Arcangelo Prete

Role: primary

Angela Tamburrini

Role: primary

Alberto Garaventa

Role: primary

Roberto Luksch

Role: primary

Marco Zecca

Role: primary

Marco Rabusin

Role: primary

Other Identifiers

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SAR-GEN_ITA

Identifier Type: -

Identifier Source: org_study_id

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