The Prognostic Value of Serum Biomarkers in Ewing's Sarcoma

Sarcoma, Ewing Clinical Trial

Official title:

The Prognostic Value of Serum Biomarkers in Ewing's Sarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05100368
• Other study ID #: PROSARC
• Status: Completed
• Start date: April 2, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: March 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuroectodermal Tumors, Primitive, Peripheral
• Sarcoma
• Sarcoma, Ewing

Intervention

Other:
• patients
Patients with Ewing's Sarcoma and osteosarcoma with established diagnosis

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Aggerholm-Pedersen N, Maretty-Kongstad K, Keller J, Baerentzen S, Safwat A. The Prognostic Value of Serum Biomarkers in Localized Bone Sarcoma. Transl Oncol. 2016 Aug;9(4):322-8. doi: 10.1016/j.tranon.2016.05.006. — View Citation

Li YJ, Yang X, Zhang WB, Yi C, Wang F, Li P. Clinical implications of six inflammatory biomarkers as prognostic indicators in Ewing sarcoma. Cancer Manag Res. 2017 Sep 28;9:443-451. doi: 10.2147/CMAR.S146827. eCollection 2017. — View Citation

Nakamura T, Grimer RJ, Gaston CL, Watanuki M, Sudo A, Jeys L. The prognostic value of the serum level of C-reactive protein for the survival of patients with a primary sarcoma of bone. Bone Joint J. 2013 Mar;95-B(3):411-8. doi: 10.1302/0301-620X.95B3.3034 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year survival	Evaluation of 5-year survival in relation to histologic, laboratory, clinical, and instrumental laboratory, clinical and instrumental factors	at baseline (Day0)
Secondary	Rate of local recurrence	Evaluation of the rate of local recurrence and distant metastasis in relation to prognostic factors histological, laboratory, clinical and instrumental factors;	at baseline (Day0)