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

Leiomyosarcoma Clinical Trial

— SAMHY2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05427461
• Other study ID #: 22 SARC 03
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2023
• Est. completion date: July 2026

Study information

• Verified date: January 2024
• Source: Institut Claudius Regaud
• Contact: Thibaud VALENTIN
• Phone: 05 31 15 51 70
• Email: valentin.thibaud[@]iuct-oncopole.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

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).

Related Conditions & MeSH terms

• Leiomyosarcoma

Intervention

Other:
• 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).

Locations

Country	Name	City	State
France	Institut Universitaire du Cancer Toulouse - Oncopole	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Institut Claudius Regaud	Fondation ARC

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The longitudinal evolution of rate of patients with "cancer cell / macrophage" hybrid cells in peripheral blood.		24 months after the end of inclusions.
Secondary	Quantification of circulating hybrid cells in peripheral blood by automatic measurement (Cell Counter Corning) and expressed in number of cells / millilitre of blood.		24 months after the end of inclusions.