The Prognostic Value of Serum Biomarkers in Osteosarcoma

Osteosarcoma Clinical Trial

Official title:

The Prognostic Value of Serum Biomarkers in Osteosarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05093101
• Other study ID #: ProOsteo
• Status: Completed
• Start date: July 12, 2021
• Est. completion date: December 22, 2021

Study information

• Verified date: October 2021
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observational retrospective cohort study using laboratory data of blood tests prior to surgical and chemotherapy treatment and other histologic, clinical, and instrumental data related to patient history from digitized medical records and analysis of the same as predictors of outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 22, 2021
• Est. primary completion date: December 22, 2021
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• Osteosarcoma diagnosed at the Pathological Anatomy of the Rizzoli Orthopaedic Institute in Bologna;
• Minimum 2-year follow-up period;
• Medical records, complete blood work and instrumental examinations, regular follow-up;
• Patients with age = 2 years;

Exclusion Criteria:

• Patients with osteosarcoma who have received medical treatment (surgery, radiotherapy or chemotherapy) in other hospitals prior to admission to our Institute

Related Conditions & MeSH terms

• Osteosarcoma

Intervention

Other:
• case series review of clinical data
Extraction of pre-surgical and chemotherapy blood test laboratory data and clinical and instrumental data related to patient history from digitized medical records and analysis

Locations

Country	Name	City	State
Italy	IRCCS Itituto Ortopedico Rizzoli	Bologna	BO

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	Evaluation of 5-year survival	Evaluation of 5-year survival in relation to histologic, laboratory, clinical, and instrumental prognostic factors	5 years
Secondary	Evaluation of the rate of local recurrence	Evaluation of the rate of local recurrence and distant metastasis in relation to histological, laboratory, clinical, and instrumental prognostic factors.	5 years