UnknownNot Applicable

Neutrophils in Bone Sarcomas

France25 participantsStarted 2020-09-01

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of the presence of neutrophils in sarcoma-affected tissues

Timeframe: Time of surgery

Trial details

NCT IDNCT04867421

SponsorUniversité de Reims Champagne-Ardenne

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-08-01

Contact for this trial

Christophe MESA

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

View on ClinicalTrials.gov More Osteosarcoma, Chondrosarcoma trials