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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05100368
Other study ID # PROSARC
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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