An observational study in Osteosarcoma, Chondrosarcoma, sponsored by Université de Reims Champagne-Ardenne. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-25.
Sponsored by Université de Reims Champagne-Ardenne · Observational
Hypothesis: Tumor infiltrating neutrophils are present in osteosarcomas and chondrosarcomas and
Experimental design: Exploratory observational research
Population: Adult patients with osteosarcoma or chondrosarcoma
Assessment criteria: Determination of the presence of TANs within tumors and their N1 or N2 profile, the presence of other immune cells, and the PDL-1 status of the tumor.
Investigation plan: Proposal to participate at all eligible patient during the preoperative consultation. If the patient agrees to participate in the study he/she will be included. Participation in the study will not affect its coverage. Patient participation will lead to:
Statistical analysis plan: Description in frequency of the presence of TANs, of N1 and N2 profiles, of the presence of other immune cells both qualitatively and quantitatively. Analysis in subgroups on relevant criteria (age, sex, location, type of tumor).
488 studies on the registry are indexed under Osteosarcoma; 124 are open to participants now.
This study's planned enrollment of 25 is below the median of 100 across 99 observational studies indexed under Osteosarcoma.
Browse Osteosarcoma studies →Université de Reims Champagne-Ardenne is the lead sponsor of 64 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients with osteosarcoma or chondrosarcoma consulting the Orthopedic and Traumatological Surgery Department of the Reims University Hospital or the Godinot Institute and undergoing tumor resection surgery
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients with osteosarcoma or chondrosarcoma
Other: No intervention
No intervention
Assessment of the presence of neutrophils in sarcoma-affected tissues
Flow cytometry analysis on excised tissues
Time frame: Time of surgery
Comparison of flow cytometry and histology for neutrophil assessment in sarcoma-affected tissues
Neutrophil identification thanks to CD66b marker with both the techniques
Time frame: Time of surgery
Identification of neutrophils N1 or N2 profile in sarcoma-affected tissues
Flow cytometry (CD45 CD66b CD182 CD184 CD195)
Time frame: Time of surgery
Identification of non-neutrophil leukocytes in sarcoma-affected tissues
Flow cytometry analysis (CD45 CD3 CD4 CD8 CD19 CD33 CD80 CD163)
Time frame: Time of surgery
Determination of PDL1 status of neutrophils in sarcoma-affected tissues
Flow cytometry analysis (CD45 CD66b CD 274)
Time frame: Time of surgery
Started Sep 2020 (actual). Primary completion is estimated for Aug 2025, 59 months after the start.
Of 41 observational studies under Osteosarcoma, half reached primary completion within 76 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 228. This study's planned 59 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Université de Reims Champagne-Ardenne