Osteosarcoma, ChondrosarcomaTANOsNCT04867421
Neutrophils in Bone Sarcomas
An observational study of Osteosarcoma, Chondrosarcoma, run by Université de Reims Champagne-Ardenne at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteosarcoma, Chondrosarcoma
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2020to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Université de Reims Champagne-Ardenne
Reims
Frédéric VELARD
About this study
Official title: Assessment of the Presence, and Characterization, of Tumor-associated Neutrophils in Bone Sarcomas: Pilot Study
Hypothesis: Tumor infiltrating neutrophils are present in osteosarcomas and chondrosarcomas and
Experimental design: Exploratory observational research
Read more
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).
- Conditions
- Osteosarcoma, Chondrosarcoma
- Being tested
- No intervention
- Keywords
- Osteosarcoma, Chondrosarcoma, Tumor associated neutrophils
- Medical subject headings
- Osteosarcoma, Chondrosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| TANOs | Adult patients with osteosarcoma or chondrosarcoma Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the presence of neutrophils in sarcoma-affected tissues
Flow cytometry analysis on excised tissues
Measured: Time of surgery
Secondary outcomes (4)
Comparison of flow cytometry and histology for neutrophil assessment in sarcoma-affected tissues
Neutrophil identification thanks to CD66b marker with both the techniques
Measured: Time of surgery
Identification of neutrophils N1 or N2 profile in sarcoma-affected tissues
Flow cytometry (CD45 CD66b CD182 CD184 CD195)
Measured: Time of surgery
Identification of non-neutrophil leukocytes in sarcoma-affected tissues
Flow cytometry analysis (CD45 CD3 CD4 CD8 CD19 CD33 CD80 CD163)
Measured: Time of surgery
Determination of PDL1 status of neutrophils in sarcoma-affected tissues
Flow cytometry analysis (CD45 CD66b CD 274)
Measured: Time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start1 Sep 2020
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteosarcoma, ChondrosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Reims Champagne-Ardenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe MESA, Principal investigator, Université de Reims Champagne-Ardenne - CHU de Reims
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867421
- Sponsor's protocol ID
- 2020-003-TANOs
- Acronym
- TANOs
- Status last verified
- May 2022
- First submitted
- 27 Apr 2021
- Last updated
- 25 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Presence, and Characterization, of Tumor-associated Neutrophils in Bone Sarcomas: Pilot Study
- ClinicalTrials.gov ID
- NCT04867421
- Acronym / sponsor ID
- TANOs / 2020-003-TANOs
- Conditions
- Osteosarcoma, Chondrosarcoma
- Keywords
- Osteosarcoma, Chondrosarcoma, Tumor associated neutrophils
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Université de Reims Champagne-ArdenneUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TANOs | – | Other: No interventionAdult patients with osteosarcoma or chondrosarcoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | TANOs |
Primary outcome
Assessment of the presence of neutrophils in sarcoma-affected tissues
Time frame: Time of surgery
Flow cytometry analysis on excised tissues
4 secondary outcomes
Comparison of flow cytometry and histology for neutrophil assessment in sarcoma-affected tissues
Time frame: Time of surgery
Identification of neutrophils N1 or N2 profile in sarcoma-affected tissues
Time frame: Time of surgery
Identification of non-neutrophil leukocytes in sarcoma-affected tissues
Time frame: Time of surgery
Determination of PDL1 status of neutrophils in sarcoma-affected tissues
Time frame: Time of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe MESA principal investigator
Université de Reims Champagne-Ardenne - CHU de Reims
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteosarcoma, Chondrosarcoma, run by Université de Reims Champagne-Ardenne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christophe MESA (03 26 78 77 51, cmensa@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the presence of neutrophils in sarcoma-affected tissues (time frame: Time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022; AzTrials last refreshed its copy on 28 Oct 2026.