Assessment of the Presence, and Characterization, of Tumor-associated Neutrophils in Bone Sarcomas: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Assessment of the presence of neutrophils in sarcoma-affected tissues
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Assessment of the presence of neutrophils in sarcoma-affected tissues
时间窗: Time of surgery
Flow cytometry analysis on excised tissues
次要结局
- 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)
- 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)