Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma?

Sarcoma Clinical Trial

— SAMHY SARCOME  

Official title:

Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04512495
• Other study ID #: 20 SARC 04
• Status: Completed
• Phase: N/A
• Start date: October 22, 2020
• Est. completion date: December 2, 2021

Study information

• Verified date: December 2021
• Source: Institut Claudius Regaud
• Contact: n/a
• 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.

The study will be conducted on a population of patients with sarcoma and treated in the context of routine care.

For each included patient, blood samples will be collected during baseline visit and after the initiation therapy.

At the end of the 2nd blood collection, the patient will have completed his participation in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2, 2021
• Est. primary completion date: December 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient with one of the following subtypes of soft tissue or bone sarcomas:

leiomyosarcoma, dedifferentiated liposarcoma, myxoid liposarcoma, synovialosarcoma, osteosarcoma, Ewing's sarcoma.

2. Diagnosis of sarcoma histologically confirmed by the RRePS network (Réseau de Référence en Pathologie des Sarcomes et des Viscères)

3. Age = 18 years old.

4. Localized or metastatic disease or recurrent disease.

5. Patient who has not yet initiated specific treatment for sarcoma.

6. Patient affiliated to a Social Health Insurance in France.

7. Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedures.

Exclusion Criteria:

1. Patient with any other histological subtype of sarcoma, including pleomorphic sarcoma.

2. Associated pathology(s) that may prevent the proper conduct of the procedure under consideration.

3. Pregnant or breastfeeding woman.

4. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of 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

• Sarcoma

Intervention

Other:
• Blood samples will be collected at two times :
at Baseline, after surgery or at the time of post-chemotherapy evaluation.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with "cancer cell / macrophage" hybrid cells in peripheral blood.		6 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.		6 months after the end of inclusions