NCT05100368

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 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

April 2, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
Last Updated

July 20, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

October 18, 2021

Last Update Submit

July 19, 2023

Conditions

Keywords

sarcoma; ewing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Rate of local recurrence

    at baseline (Day0)

Study Arms (1)

Patients

Patients with Ewing's Sarcoma and osteosarcoma with established diagnosis

Other: patients

Interventions

Patients with Ewing's Sarcoma and osteosarcoma with established diagnosis

Patients

Eligibility Criteria

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

Patients with Ewing's sarcoma or osteosarcoma

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Sarcoma, Ewing

Condition Hierarchy (Ancestors)

OsteosarcomaNeoplasms, 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 18, 2021

First Posted

October 29, 2021

Study Start

April 2, 2021

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

July 20, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations