The Prognostic Value of Serum Biomarkers in Ewing's Sarcoma

• Sponsor: Istituto Ortopedico Rizzoli (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05100368
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 15.9
• Patients Per Site Per Month: 62.8

Study Details

Study Description

Brief Summary

Extraction of laboratory data from blood tests prior to surgical and chemotherapy and other histological, clinical and instrumental data related to the patient's history from the digitized medical Digitized medical records and analysis of the same. The medical records of 1000 patients from January 1, 2000, until December 31, 2020

Condition or Disease	Intervention/Treatment	Phase
Sarcoma, Ewing	Other: patients

Study Design

• Study Type: Observational
• Actual Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: The Prognostic Value of Serum Biomarkers in Ewing's Sarcoma
• Actual Study Start Date: Apr 2, 2021
• Anticipated Primary Completion Date: Jul 31, 2022
• Anticipated Study Completion Date: Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients Patients with Ewing's Sarcoma and osteosarcoma with established diagnosis	Other: patients; Patients with Ewing's Sarcoma and osteosarcoma with established diagnosis

Outcome Measures

Primary Outcome Measures

1. 5-year survival [at baseline (Day0)]

   Evaluation of 5-year survival in relation to histologic, laboratory, clinical, and instrumental laboratory, clinical and instrumental factors

Secondary Outcome Measures

1. Rate of local recurrence [at baseline (Day0)]

   Evaluation of the rate of local recurrence and distant metastasis in relation to prognostic factors histological, laboratory, clinical and instrumental factors;

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with Ewing's Sarcoma and osteosarcoma with established diagnosis;

• Patients with age ≥ 2 years;

• Minimum follow-up duration of 2 years;

• Medical records, complete blood work and instrumental examinations; Regular follow-up.

Exclusion Criteria:

• Patients with Ewing's sarcoma or osteosarcoma who have received medical treatment (surgery radiotherapy or chemotherapy) in other institutions prior to admission to the Rizzoli Orthopaedic Institute.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituto Ortopedico Rizzoli	Bologna		Italy	40136

Sponsors and Collaborators

• Istituto Ortopedico Rizzoli

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Costantino Errani, Principal Investigator, Istituto Ortopedico Rizzoli
• ClinicalTrials.gov Identifier: NCT05100368
• Other Study ID Numbers: PROSARC
• First Posted: Oct 29, 2021
• Last Update Posted: Apr 5, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Costantino Errani, Principal Investigator, Istituto Ortopedico Rizzoli: sarcoma; ewing
• Additional relevant MeSH terms: Sarcoma; Sarcoma, Ewing; Neuroectodermal Tumors, Primitive, Peripheral

Study Results

No Results Posted as of Apr 5, 2022