OsteosarcomaNCT05093101
The Prognostic Value of Serum Biomarkers in Osteosarcoma
An observational study of Osteosarcoma, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- case series review of clinical data
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jul 2021to 22 Dec 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
- Child, Adult, Older adult
Study population: pazients with osteosarcoma from 01-01-2000 to 31-12-2020
Who may be able to join
- 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;
Who cannot join
- Patients with osteosarcoma who have received medical treatment (surgery, radiotherapy or chemotherapy) in other hospitals prior to admission to our Institute
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Osteosarcoma
- Being tested
- case series review of clinical data
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
case series review of clinical dataOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of 5-year survival
Evaluation of 5-year survival in relation to histologic, laboratory, clinical, and instrumental prognostic factors
Measured: 5 years
Secondary outcomes (1)
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start12 Jul 2021
- Primary completion22 Dec 2021
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OsteosarcomaStudies 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
- 600 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
- NCT05093101
- Sponsor's protocol ID
- ProOsteo
- Status last verified
- Oct 2021
- First submitted
- 12 Oct 2021
- Last updated
- 5 Apr 2022
- Results posted
- 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 27567955Basoli 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.
PubMed 37504371
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Value of Serum Biomarkers in Osteosarcoma
- ClinicalTrials.gov ID
- NCT05093101
- Acronym / sponsor ID
- ProOsteo
- Conditions
- Osteosarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 26 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- pazients with osteosarcoma from 01-01-2000 to 31-12-2020
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (1 listed)
- Patients with osteosarcoma who have received medical treatment (surgery, radiotherapy or chemotherapy) in other hospitals prior to admission to our 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 |
|---|---|---|
| case series review of clinical dataExtraction of pre-surgical and chemotherapy blood test laboratory data and clinical and instrumental data related to patient history from digitized medical records and analysis | Other | – |
Primary outcome
Evaluation of 5-year survival
Time frame: 5 years
Evaluation of 5-year survival in relation to histologic, laboratory, clinical, and instrumental prognostic factors
1 secondary outcome
Evaluation of the rate of local recurrence
Time frame: 5 years
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 5 Apr 2022.
- 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.
- Derived from this study: PubMed 37504371Basoli 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.
- Individual participant dataSharing planned: No
Related trials for Osteosarcoma
RecruitingPhase 2
The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma
Osteosarcoma in Children, Osteosarcoma in Adolescents and Young Adults
Active, not recruitingPhase 2
Oleclumab and Durvalumab for the Treatment of Recurrent, Refractory, or Metastatic Sarcoma
Metastatic Angiosarcoma, Metastatic Dedifferentiated Liposarcoma
RecruitingObservational study
Observational Study in Localized Osteosarcoma
Localized Osteosarcoma
RecruitingPhase 2
Evaluating Efficacy of B7-H3-CAR T Cells Administered at the End of Upfront Map Chemotherapy in Patients With Newly Diagnosed High-Risk Osteosarcoma
Pediatric Osteosarcoma
Not yet recruitingPhase 1
GD2IL18CART Combined With Bevacizumab for Relapsed and Refractory GD2-positive Solid Tumors
Neuroblastoma (NBL), Ewing Sarcoma
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 Osteosarcoma, 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 5 Apr 2022. 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?
Evaluation of 5-year survival (time frame: 5 years). 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 NCT05093101, which also lists 4 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 5 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.