CClinicalTrials.gg
Active, not recruitingNCT05427461SAMHY2Updated Jun 3, 2025

Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma, Part 2

An interventional study of Blood samples will be collected at different times. in Leiomyosarcoma, sponsored by Institut Claudius Regaud. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-03.

Sponsored by Institut Claudius Regaud · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Leiomyosarcoma

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Keywords

  • Leiomyosarcoma
  • Cancer cell/macrophage hybrid cells
  • Hybrid cells
03

In context

Leiomyosarcoma

147 studies on the registry are indexed under Leiomyosarcoma; 33 are open to participants now.

This study's planned enrollment of 20 is below the median of 45 across 121 interventional studies indexed under Leiomyosarcoma.

Browse Leiomyosarcoma studies →

Lead sponsor

Institut Claudius Regaud is the lead sponsor of 117 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient with leiomyosarcoma.
  2. Diagnosis of sarcoma histologically confirmed by the RRePS network (Réseau de Référence en Pathologie des Sarcomes et des Viscères)
  3. Localized or metastatic disease
  4. Newly diagnosed patient who has not yet initiated specific treatment for sarcoma
  5. Age ≥ 18 years
  6. Patient affiliated to a Social Security system in France.
  7. Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedures

Exclusion criteria

Exclusion Criteria:

  1. Diagnosis of any other histological subtype of soft tissue sarcoma
  2. Associated pathology(ies) that may interfere with the study procedure
  3. Pregnant or breastfeeding woman
  4. 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.
  5. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    Patient with leiomyosarcoma

    Other: Blood samples will be collected at different times.

Interventions

  • OtherBlood 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).

06

What researchers measure

Primary outcomes

  1. 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.

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.

    Time frame: 24 months after the end of inclusions.

07

Study locations

1 site
  • Institut Universitaire du Cancer Toulouse - Oncopole
    Toulouse, 31059, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05427461
Lead sponsor
Institut Claudius Regaud
Collaborators
Fondation ARC
Responsible party
Sponsor
First posted
Jun 22, 2022
Start date
Jan 13, 2023
Primary completion
Jul 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
Jun 3, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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