Sarcoma, EwingNCT05100368
The Prognostic Value of Serum Biomarkers in Ewing's Sarcoma
An observational study of Sarcoma, Ewing, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Sarcoma, Ewing
- What is being tested?
- patients
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 2 Apr 2021to 1 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Ewing's sarcoma or osteosarcoma
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Sarcoma, Ewing
- Being tested
- patients
- Keywords
- sarcoma; ewing
- Medical subject headings
- Sarcoma, Ewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patientsOther
Patients with Ewing's Sarcoma and osteosarcoma with established diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with Ewing's Sarcoma and osteosarcoma with established diagnosis Receives: Other: patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year survival
Evaluation of 5-year survival in relation to histologic, laboratory, clinical, and instrumental laboratory, clinical and instrumental factors
Measured: at baseline (Day0)
Secondary outcomes (1)
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;
Measured: at baseline (Day0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start2 Apr 2021
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sarcoma, EwingStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Costantino Errani, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100368
- Sponsor's protocol ID
- PROSARC
- Status last verified
- Mar 2023
- First submitted
- 18 Oct 2021
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23450030Li 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.
PubMed 29033609Aggerholm-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.
PubMed 27567955
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Value of Serum Biomarkers in Ewing's Sarcoma
- ClinicalTrials.gov ID
- NCT05100368
- Acronym / sponsor ID
- PROSARC
- Conditions
- Sarcoma, Ewing
- Keywords
- sarcoma; ewing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: patientsPatients with Ewing's Sarcoma and osteosarcoma with established diagnosis |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Ewing's sarcoma or osteosarcoma
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patientsPatients with Ewing's Sarcoma and osteosarcoma with established diagnosis | Other | Patients |
Primary outcome
5-year survival
Time frame: at baseline (Day0)
Evaluation of 5-year survival in relation to histologic, laboratory, clinical, and instrumental laboratory, clinical and instrumental factors
1 secondary outcome
Rate of local recurrence
Time frame: at baseline (Day0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Results publication: PubMed 23450030Nakamura 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.
- Results publication: PubMed 29033609Li 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.
- Results publication: PubMed 27567955Aggerholm-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma, Ewing, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year survival (time frame: at baseline (Day0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05100368, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.