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Neutrophils in Bone Sarcomas (TANOs)

U

Université de Reims Champagne-Ardenne

Status

Enrolling

Conditions

Osteosarcoma, Chondrosarcoma

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT04867421
2020-003-TANOs

Details and patient eligibility

About

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).

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

25 participants in 1 patient group

TANOs
Description:
Adult patients with osteosarcoma or chondrosarcoma
Treatment:
Other: No intervention

Trial contacts and locations

1

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Central trial contact

Frédéric VELARD; Christophe MESA

Data sourced from clinicaltrials.gov

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