Neutrophils in Bone Sarcomas

NCT ID: NCT04867421

Last Updated: 2022-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2025-08-01

Brief Summary

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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).

Detailed Description

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Conditions

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Osteosarcoma, Chondrosarcoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TANOs

Adult patients with osteosarcoma or chondrosarcoma

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université de Reims Champagne-Ardenne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christophe MESA

Role: PRINCIPAL_INVESTIGATOR

Université de Reims Champagne-Ardenne - CHU de Reims

Locations

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Université de Reims Champagne-Ardenne

Reims, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Christophe MESA

Role: CONTACT

03 26 78 77 51

Frédéric VELARD

Role: CONTACT

03 26 91 80 10

Facility Contacts

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Frédéric VELARD

Role: primary

Other Identifiers

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2020-003-TANOs

Identifier Type: -

Identifier Source: org_study_id

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