Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma, Part 2 (SAMHY2)

Institut Claudius Regaud

Status: Active, not recruiting

Conditions: Leiomyosarcoma

Treatments: Other: Blood samples will be collected at different times.

Study type: Interventional

Funder types: Other

Identifiers

NCT05427461

22 SARC 03

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Patient with leiomyosarcoma

Other group

Treatment:

Other: Blood samples will be collected at different times.