Clinical trial NCT04867421: Neutrophils in Bone Sarcomas
Official title: Assessment of the Presence, and Characterization, of Tumor-associated Neutrophils in Bone Sarcomas: Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteosarcoma, Chondrosarcoma
Keywords: Osteosarcoma
Chondrosarcoma
Tumor associated neutrophils
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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).


Eligibility criteria: 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)

Primary outcomes:
measure: Assessment of the presence of neutrophils in sarcoma-affected tissues
timeFrame: Time of surgery
Secondary outcomes:
measure: Comparison of flow cytometry and histology for neutrophil assessment in sarcoma-affected tissues
timeFrame: Time of surgery
measure: Identification of neutrophils N1 or N2 profile in sarcoma-affected tissues
timeFrame: Time of surgery
measure: Identification of non-neutrophil leukocytes in sarcoma-affected tissues
timeFrame: Time of surgery
measure: Determination of PDL1 status of neutrophils in sarcoma-affected tissues
timeFrame: Time of surgery
Other outcomes:
Locations:
city: Reims
country: France
facility: Université de Reims Champagne-Ardenne
Study officials:
affiliation: Université de Reims Champagne-Ardenne - CHU de Reims
name: Christophe MESA
role: PRINCIPAL_INVESTIGATOR
References: