LeiomyosarcomaSAMHY2NCT05427461
Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma, Part 2
A study testing Blood samples will be collected at different times. in people with Leiomyosarcoma, 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 and the evolution of this rate over time. The study will be conducted on a population of patients with leiomyosarcoma 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
- Leiomyosarcoma
- What is being tested?
- Blood samples will be collected at different times.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2023to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 leiomyosarcoma.
- Diagnosis of sarcoma histologically confirmed by the RRePS network (Réseau de Référence en Pathologie des Sarcomes et des Viscères)
- Localized or metastatic disease
- Newly diagnosed patient who has not yet initiated specific treatment for sarcoma
- Age ≥ 18 years
- Patient affiliated to a Social Security system in France.
- Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedures
Who cannot join
- Diagnosis of any other histological subtype of soft tissue sarcoma
- Associated pathology(ies) that may interfere with the study procedure
- Pregnant or breastfeeding woman
- Any psychological, family, geographical or sociological condition that does not allow for compliance with the medical follow-up and/or procedures provided for in 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 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 and the evolution of this rate over time.
The study will be conducted on a population of patients with leiomyosarcoma and treated in the context of routine care. 20 patients will be included:
- 10 patients with localized disease.
- 10 patients with metastatic disease.
For each included patient, blood samples will be collected during baseline visit and up to 24 months after inclusion.
- Conditions
- Leiomyosarcoma
- Being tested
- Blood samples will be collected at different times.
- Keywords
- Leiomyosarcoma, Cancer cell/macrophage hybrid cells, Hybrid cells
- Medical subject headings
- Leiomyosarcoma
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 different times.Other
For patients with localized leiomyosarcoma, samples will be collected:
- At Baseline.
- Before surgery (for patients who have had neoadjuvant treatment (external radiotherapy and/or chemotherapy)).
- After surgery.
- At each control visit.
- At local or metastatic recurrence (or at 24 months post inclusion if no progression).
For patients with metastatic leiomyosarcoma, samples will be collected:
- At Baseline.
- At each therapeutic line.
- At progression (or at 24 months post inclusion if no progression).
| Study group | Role | What they receive |
|---|---|---|
| Patient with leiomyosarcoma | Other | Not described Receives: Other: Blood samples will be collected at different times. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The longitudinal evolution of rate of patients with "cancer cell / macrophage" hybrid cells in peripheral blood.
Measured: 24 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: 24 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 posted22 Jun 2022
- Study start13 Jan 2023
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeiomyosarcomaStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation ARC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427461
- Sponsor's protocol ID
- 22 SARC 03
- Acronym
- SAMHY2
- Status last verified
- May 2025
- First submitted
- 16 Jun 2022
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. 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, Part 2
- ClinicalTrials.gov ID
- NCT05427461
- Acronym / sponsor ID
- SAMHY2 / 22 SARC 03
- Conditions
- Leiomyosarcoma
- Keywords
- Leiomyosarcoma, Cancer cell/macrophage hybrid cells, Hybrid cells
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Collaborators
- Fondation ARC
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 22 Jun 2022 (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 and the evolution of this rate over time.
The study will be conducted on a population of patients with leiomyosarcoma and treated in the context of routine care. 20 patients will be included:
- 10 patients with localized disease.
- 10 patients with metastatic disease.
For each included patient, blood samples will be collected during baseline visit and up to 24 months after inclusion.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with leiomyosarcoma | Other | Other: Blood samples will be collected at different 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 leiomyosarcoma.
- Diagnosis of sarcoma histologically confirmed by the RRePS network (Réseau de Référence en Pathologie des Sarcomes et des Viscères)
- Localized or metastatic disease
- Newly diagnosed patient who has not yet initiated specific treatment for sarcoma
- Age ≥ 18 years
Key exclusion criteria (5 listed)
- Diagnosis of any other histological subtype of soft tissue sarcoma
- Associated pathology(ies) that may interfere with the study procedure
- Pregnant or breastfeeding woman
- Any psychological, family, geographical or sociological condition that does not allow for compliance with the medical follow-up and/or procedures provided for in 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 different times.For patients with localized leiomyosarcoma, samples will be collected: * At Baseline. * Before surgery (for patients who have had neoadjuvant treatment (external radiotherapy and/or chemotherapy)). * After surgery. * At each control visit. * At local or metastatic recurrence (or at 24 months post inclusion if no progression). For patients with metastatic leiomyosarcoma, samples will be collected: * At Baseline. * At each therapeutic line. * At progression (or at 24 months post inclusion if no progression). | Other | Patient with leiomyosarcoma |
Primary outcome
The longitudinal evolution of rate of patients with "cancer cell / macrophage" hybrid cells in peripheral blood.
Time frame: 24 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: 24 months after the end of inclusions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
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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.
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 different times. in people with Leiomyosarcoma, 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: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
The longitudinal evolution of rate of patients with "cancer cell / macrophage" hybrid cells in peripheral blood. (time frame: 24 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 3 Jun 2025.