NCT05093101

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2021

Completed
Last Updated

April 5, 2022

Status Verified

October 1, 2021

Enrollment Period

5 months

First QC Date

October 12, 2021

Last Update Submit

March 25, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of 5-year survival

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

    5 years

Secondary Outcomes (1)

  • Evaluation of the rate of local recurrence

    5 years

Interventions

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

Eligibility Criteria

Age2 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

pazients with osteosarcoma from 01-01-2000 to 31-12-2020

You may qualify if:

  • 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;

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Itituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

Location

Related Publications (4)

  • 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.95B3.30344.

  • 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.

  • 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.

  • Basoli S, Cosentino M, Traversari M, Manfrini M, Tsukamoto S, Mavrogenis AF, Bordini B, Donati DM, Errani C. The Prognostic Value of Serum Biomarkers for Survival of Children with Osteosarcoma of the Extremities. Curr Oncol. 2023 Jul 24;30(7):7043-7054. doi: 10.3390/curroncol30070511.

MeSH Terms

Conditions

Osteosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcoma

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 12, 2021

First Posted

October 26, 2021

Study Start

July 12, 2021

Primary Completion

December 22, 2021

Study Completion

December 22, 2021

Last Updated

April 5, 2022

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations