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Neutrophils in Bone Sarcomas (TANOs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04867421
Recruitment Status : Recruiting
First Posted : April 30, 2021
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
Université de Reims Champagne-Ardenne

Study Description
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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).


Condition or disease Intervention/treatment
Osteosarcoma, Chondrosarcoma Other: No intervention

Study Design
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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of the Presence, and Characterization, of Tumor-associated Neutrophils in Bone Sarcomas: Pilot Study
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : August 1, 2025
Estimated Study Completion Date : August 1, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
TANOs
Adult patients with osteosarcoma or chondrosarcoma
 Other: No intervention
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of the presence of neutrophils in sarcoma-affected tissues [ Time Frame: Time of surgery ]
    Flow cytometry analysis on excised tissues


Secondary Outcome Measures :
  1. Comparison of flow cytometry and histology for neutrophil assessment in sarcoma-affected tissues [ Time Frame: Time of surgery ]
    Neutrophil identification thanks to CD66b marker with both the techniques

  2. Identification of neutrophils N1 or N2 profile in sarcoma-affected tissues [ Time Frame: Time of surgery ]
    Flow cytometry (CD45 CD66b CD182 CD184 CD195)

  3. Identification of non-neutrophil leukocytes in sarcoma-affected tissues [ Time Frame: Time of surgery ]
    Flow cytometry analysis (CD45 CD3 CD4 CD8 CD19 CD33 CD80 CD163)

  4. Determination of PDL1 status of neutrophils in sarcoma-affected tissues [ Time Frame: Time of surgery ]
    Flow cytometry analysis (CD45 CD66b CD 274)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04867421


Contacts
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Contact: Christophe MESA 03 26 78 77 51 cmensa@chu-reims.fr
Contact: Frédéric VELARD 03 26 91 80 10 frederic.velard@univ-reims.fr

Locations
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France
Université de Reims Champagne-Ardenne Recruiting
Reims, France
Contact: Frédéric VELARD         
Sponsors and Collaborators
Université de Reims Champagne-Ardenne
Investigators
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Principal Investigator: Christophe MESA Université de Reims Champagne-Ardenne - CHU de Reims
More Information
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Responsible Party: Université de Reims Champagne-Ardenne
ClinicalTrials.gov Identifier: NCT04867421    
Other Study ID Numbers: 2020-003-TANOs
First Posted: April 30, 2021    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Université de Reims Champagne-Ardenne:
Osteosarcoma
Chondrosarcoma
Tumor associated neutrophils
Additional relevant MeSH terms:
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Osteosarcoma
Chondrosarcoma
Sarcoma
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue