Neutrophils in Bone Sarcomas

NCT04867421 | Unknown

• 1 other identifier: 2020-003-TANOs
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteosarcoma, Chondrosarcoma

Keywords

Osteosarcoma; Chondrosarcoma; Tumor associated neutrophils

Outcome Measures

Primary Outcomes (1)

• Assessment of the presence of neutrophils in sarcoma-affected tissues

  Flow cytometry analysis on excised tissues

  Time of surgery

Secondary Outcomes (4)

• Comparison of flow cytometry and histology for neutrophil assessment in sarcoma-affected tissues

  Time of surgery

• Identification of neutrophils N1 or N2 profile in sarcoma-affected tissues

  Time of surgery

• Identification of non-neutrophil leukocytes in sarcoma-affected tissues

  Time of surgery

• Determination of PDL1 status of neutrophils in sarcoma-affected tissues

  Time of surgery

Study Arms (1)

TANOs

Adult patients with osteosarcoma or chondrosarcoma

Other: No intervention

Interventions

No intervention OTHER

No intervention

TANOs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Université de Reims Champagne-Ardenne: lead

Study Sites (1)

Université de Reims Champagne-Ardenne

Reims, France

RECRUITING

MeSH Terms

Conditions

Osteosarcoma; Chondrosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Officials

• Christophe MESA

  Université de Reims Champagne-Ardenne - CHU de Reims

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe MESA

CONTACT

03 26 78 77 51; cmensa@chu-reims.fr

Frédéric VELARD

CONTACT

03 26 91 80 10; frederic.velard@univ-reims.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 30, 2021
• Study Start: September 1, 2020
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

FR (1)