Back to resultsCirculating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma? (SAMHY SARCOME)
Primary Purpose
Sarcoma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples will be collected at two times :
Sponsored by
About this trial
This is an interventional other trial for Sarcoma focused on measuring Leiomyosarcoma, Dedifferentiated liposarcoma, Myxoid liposarcoma, Synovialosarcoma, Osteosarcoma, Ewing's sarcoma, Cancer cell/macrophage hybrid cells, Hybrid cells
Eligibility Criteria
Inclusion Criteria:
- Patient with one of the following subtypes of soft tissue or bone sarcomas: leiomyosarcoma, dedifferentiated liposarcoma, myxoid liposarcoma, synovialosarcoma, osteosarcoma, Ewing's sarcoma.
- Diagnosis of sarcoma histologically confirmed by the RRePS network (Réseau de Référence en Pathologie des Sarcomes et des Viscères)
- Age ≥ 18 years old.
- Localized or metastatic disease or recurrent disease.
- Patient who has not yet initiated specific treatment for sarcoma.
- Patient affiliated to a Social Health Insurance in France.
- Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedures.
Exclusion Criteria:
- Patient with any other histological subtype of sarcoma, including pleomorphic sarcoma.
- Associated pathology(s) that may prevent the proper conduct of the procedure under consideration.
- Pregnant or breastfeeding woman.
- Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Sites / Locations
- Institut Universitaire du Cancer de Toulouse - Oncopole
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with sarcoma
Arm Description
Outcomes
Primary Outcome Measures
Rate of patients with "cancer cell / macrophage" hybrid cells in peripheral blood.
Secondary Outcome Measures
Quantification of circulating hybrid cells in peripheral blood by automatic measurement (Cell Counter Corning) and expressed in number of cells / millilitre of blood.
Full Information
NCT ID
NCT04512495
First Posted
August 7, 2020
Last Updated
December 9, 2021
Sponsor
Institut Claudius Regaud
1. Study Identification
Unique Protocol Identification Number
NCT04512495
Brief Title
Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma?
Acronym
SAMHY SARCOME
Official Title
Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 22, 2020 (Actual)
Primary Completion Date
December 2, 2021 (Actual)
Study Completion Date
December 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
Leiomyosarcoma, Dedifferentiated liposarcoma, Myxoid liposarcoma, Synovialosarcoma, Osteosarcoma, Ewing's sarcoma, Cancer cell/macrophage hybrid cells, Hybrid cells
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with sarcoma
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Blood samples will be collected at two times :
Intervention Description
at Baseline,
after surgery or at the time of post-chemotherapy evaluation.
Primary Outcome Measure Information:
Title
Rate of patients with "cancer cell / macrophage" hybrid cells in peripheral blood.
Time Frame
6 months after the end of inclusions
Secondary Outcome Measure Information:
Title
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
6 months after the end of inclusions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with one of the following subtypes of soft tissue or bone sarcomas: leiomyosarcoma, dedifferentiated liposarcoma, myxoid liposarcoma, synovialosarcoma, osteosarcoma, Ewing's sarcoma.
Diagnosis of sarcoma histologically confirmed by the RRePS network (Réseau de Référence en Pathologie des Sarcomes et des Viscères)
Age ≥ 18 years old.
Localized or metastatic disease or recurrent disease.
Patient who has not yet initiated specific treatment for sarcoma.
Patient affiliated to a Social Health Insurance in France.
Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedures.
Exclusion Criteria:
Patient with any other histological subtype of sarcoma, including pleomorphic sarcoma.
Associated pathology(s) that may prevent the proper conduct of the procedure under consideration.
Pregnant or breastfeeding woman.
Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.
Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Facility Information:
Facility Name
Institut Universitaire du Cancer de Toulouse - Oncopole
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Learn more about this trial
Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma?
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