SarcomaSAMHY SARCOMENCT04512495
Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma?
A study testing Blood samples will be collected at two times : in people with Sarcoma, run by Institut Claudius Regaud at 1 site in France.
Trial summary
Pilot, prospective, monocentric study aimed at evaluating the rate of patients with circulating "cancer cell/macrophage" hybrid cells in the peripheral blood. The study will be conducted on a population of patients with sarcoma and treated in the context of routine care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- Blood samples will be collected at two times :
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 22 Oct 2020to 2 Dec 2021
- Phase
- Interventional
- 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
Who may be able to join
- Patient with one of the following subtypes of soft tissue or bone sarcomas: leiomyosarcoma, dedifferentiated liposarcoma, myxoid liposarcoma, synovialosarcoma, osteosarcoma, Ewing's sarcoma.
- Diagnosis of sarcoma histologically confirmed by the RRePS network (Réseau de Référence en Pathologie des Sarcomes et des Viscères)
- Age ≥ 18 years old.
- Localized or metastatic disease or recurrent disease.
- Patient who has not yet initiated specific treatment for sarcoma.
- Patient affiliated to a Social Health Insurance in France.
- Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedures.
Who cannot join
- Patient with any other histological subtype of sarcoma, including pleomorphic sarcoma.
- Associated pathology(s) that may prevent the proper conduct of the procedure under consideration.
- Pregnant or breastfeeding woman.
- Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, 31059
About this study
Pilot, prospective, monocentric study aimed at evaluating the rate of patients with circulating "cancer cell/macrophage" hybrid cells in the peripheral blood.
The study will be conducted on a population of patients with sarcoma and treated in the context of routine care.
For each included patient, blood samples will be collected during baseline visit and after the initiation therapy.
At the end of the 2nd blood collection, the patient will have completed his participation in the study.
- Conditions
- Sarcoma
- Being tested
- Blood samples will be collected at two times :
- Keywords
- Leiomyosarcoma, Dedifferentiated liposarcoma, Myxoid liposarcoma, Synovialosarcoma, Osteosarcoma, Ewing's sarcoma, Cancer cell/macrophage hybrid cells, Hybrid cells
- Medical subject headings
- Sarcoma, Leiomyosarcoma, Liposarcoma, Liposarcoma, Myxoid, Sarcoma, Synovial, Osteosarcoma, Sarcoma, Ewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples will be collected at two times :Other
- at Baseline,
- after surgery or at the time of post-chemotherapy evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Patients with sarcoma | Other | Not described Receives: Other: Blood samples will be collected at two times : |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with "cancer cell / macrophage" hybrid cells in peripheral blood.
Measured: 6 months after the end of inclusions
Secondary outcomes (1)
Quantification of circulating hybrid cells in peripheral blood by automatic measurement (Cell Counter Corning) and expressed in number of cells / millilitre of blood.
Measured: 6 months after the end of inclusions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start22 Oct 2020
- Primary completion2 Dec 2021
- Study completion2 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512495
- Sponsor's protocol ID
- 20 SARC 04
- Acronym
- SAMHY SARCOME
- Status last verified
- Dec 2021
- First submitted
- 7 Aug 2020
- Last updated
- 10 Dec 2021
- 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 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma?
- ClinicalTrials.gov ID
- NCT04512495
- Acronym / sponsor ID
- SAMHY SARCOME / 20 SARC 04
- Conditions
- Sarcoma
- Keywords
- Leiomyosarcoma, Dedifferentiated liposarcoma, Myxoid liposarcoma, Synovialosarcoma, Osteosarcoma, Ewing's sarcoma, Cancer cell/macrophage hybrid cells, Hybrid cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 13 Aug 2020 (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.
Pilot, prospective, monocentric study aimed at evaluating the rate of patients with circulating "cancer cell/macrophage" hybrid cells in the peripheral blood.
The study will be conducted on a population of patients with sarcoma and treated in the context of routine care.
For each included patient, blood samples will be collected during baseline visit and after the initiation therapy.
At the end of the 2nd blood collection, the patient will have completed his participation in the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with sarcoma | Other | Other: Blood samples will be collected at two times : |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient with one of the following subtypes of soft tissue or bone sarcomas: leiomyosarcoma, dedifferentiated liposarcoma, myxoid liposarcoma, synovialosarcoma, osteosarcoma, Ewing's sarcoma.
- Diagnosis of sarcoma histologically confirmed by the RRePS network (Réseau de Référence en Pathologie des Sarcomes et des Viscères)
- Age ≥ 18 years old.
- Localized or metastatic disease or recurrent disease.
- Patient who has not yet initiated specific treatment for sarcoma.
Key exclusion criteria (5 listed)
- Patient with any other histological subtype of sarcoma, including pleomorphic sarcoma.
- Associated pathology(s) that may prevent the proper conduct of the procedure under consideration.
- Pregnant or breastfeeding woman.
- Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
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 |
|---|---|---|
| Blood samples will be collected at two times :* at Baseline, * after surgery or at the time of post-chemotherapy evaluation. | Other | Patients with sarcoma |
Primary outcome
Rate of patients with "cancer cell / macrophage" hybrid cells in peripheral blood.
Time frame: 6 months after the end of inclusions
1 secondary outcome
Quantification of circulating hybrid cells in peripheral blood by automatic measurement (Cell Counter Corning) and expressed in number of cells / millilitre of blood.
Time frame: 6 months after the end of inclusions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
Related trials for Sarcoma
RecruitingPhase 2
A Multicenter Phase II Clinical Trial Evaluating 68Ga-HX01 Injection for PET/CT Imaging
Soft Tissue Sarcoma
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Enrolling by invitationPhase 1
Evaluation of the I-phase Clinical Trial of 177Lu-HX02 Injection in Patients With Advanced Malignant Solid Tumors
Soft Tissue Sarcoma, Non-small Cell Lung Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples will be collected at two times : in people with Sarcoma, run by Institut Claudius Regaud 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 10 Dec 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with "cancer cell / macrophage" hybrid cells in peripheral blood. (time frame: 6 months after the end of inclusions). 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 10 Dec 2021.