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

• Sponsor: Institut Claudius Regaud (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05427461
• Collaborator: Fondation ARC (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 45
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Leiomyosarcoma	Other: Blood samples will be collected at different times.	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma, Part 2
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Jul 1, 2026
• Anticipated Study Completion Date: Jul 1, 2026

Arms and Interventions

Arm

Intervention/Treatment

Other: Patient with leiomyosarcoma

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).

Outcome Measures

Primary Outcome Measures

1. The longitudinal evolution of rate of patients with "cancer cell / macrophage" hybrid cells in peripheral blood. [24 months after the end of inclusions.]

Secondary Outcome Measures

1. 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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Universitaire du Cancer Toulouse - Oncopole	Toulouse		France	31059

Sponsors and Collaborators

• Institut Claudius Regaud
• Fondation ARC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut Claudius Regaud
• ClinicalTrials.gov Identifier: NCT05427461
• Other Study ID Numbers: 22 SARC 03
• First Posted: Jun 22, 2022
• Last Update Posted: Aug 4, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Institut Claudius Regaud: Leiomyosarcoma; Cancer cell/macrophage hybrid cells; Hybrid cells
• Additional relevant MeSH terms: Sarcoma; Leiomyosarcoma

Study Results

No Results Posted as of Aug 4, 2022