Neutrophils in Bone Sarcomas (TANOs)

Assessment of the Presence, and Characterization, of Tumor-associated Neutrophils in Bone Sarcomas: Pilot Study

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:

• Taking samples from an operative part,
• The collection of demographic data (age, sex, height, weight, body mass index), family history of cancer, history of bone trauma, sports practice, clinical and anatomopathology reports and data, medical history (Diabetes, Cardiovascular Diseases, Infectious Diseases, Autoimmune Diseases, Bone Metabolism Disorders, Allergies, Menopause, Drug treatments followed, Psychiatric disorders).

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).

Study Overview

• Status: Recruiting
• Conditions: Osteosarcoma, Chondrosarcoma
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

• Study Contact: Name: Christophe MESA; Phone Number: 03 26 78 77 51; Email: cmensa@chu-reims.fr

Study Locations

• France
  • Reims, France
    • Recruiting
    • Université de Reims Champagne-Ardenne
    • Contact: Frédéric VELARD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Patient of 18 years and more
• Patient of the Orthopedic and Traumatological Surgery Department of the Reims University Hospital or the Godinot Institute
• Patient with osteosarcoma or chondrosarcoma to be operated on regardless of stage.
• Patient agreeing to participate in the study (informed consent form)
• Patient fluent in French
• Patient affiliated with a social security regimen

Exclusion Criteria:

• Patient having a medical history that may compromise the protocol (psychiatric, medical or pharmacological disorders such as the use of anti-inflammatory drugs, or any compound that may alter or modify the inflammatory reaction in the week preceding the protocol).
• Pregnant or breastfeeding women
• Patient with eating disorders (anorexia, bulimia, overeating)
• Patient protected by law (guardianship, curatorship, hospitalized without their consent and not protected by law, deprived of liberty)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TANOs; Adult patients with osteosarcoma or chondrosarcoma	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the presence of neutrophils in sarcoma-affected tissues	Flow cytometry analysis on excised tissues	Time of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of flow cytometry and histology for neutrophil assessment in sarcoma-affected tissues	Neutrophil identification thanks to CD66b marker with both the techniques	Time of surgery
Identification of neutrophils N1 or N2 profile in sarcoma-affected tissues	Flow cytometry (CD45 CD66b CD182 CD184 CD195)	Time of surgery
Identification of non-neutrophil leukocytes in sarcoma-affected tissues	Flow cytometry analysis (CD45 CD3 CD4 CD8 CD19 CD33 CD80 CD163)	Time of surgery
Determination of PDL1 status of neutrophils in sarcoma-affected tissues	Flow cytometry analysis (CD45 CD66b CD 274)	Time of surgery

Collaborators and Investigators

• Sponsor: Université de Reims Champagne-Ardenne
• Investigators: Principal Investigator: Christophe MESA, Université de Reims Champagne-Ardenne - CHU de Reims

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): August 1, 2025
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): April 30, 2021

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Osteosarcoma; Chondrosarcoma; Tumor associated neutrophils
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Sarcoma; Osteosarcoma; Chondrosarcoma
• Other Study ID Numbers: 2020-003-TANOs

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No