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

Primary Purpose

Leiomyosarcoma

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples will be collected at different times.
Sponsored by
Institut Claudius Regaud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Leiomyosarcoma focused on measuring Leiomyosarcoma, Cancer cell/macrophage hybrid cells, Hybrid cells

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Institut Universitaire du Cancer Toulouse - OncopoleRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patient with leiomyosarcoma

Arm Description

Outcomes

Primary Outcome Measures

The longitudinal evolution of 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

First Posted
June 16, 2022
Last Updated
January 18, 2023
Sponsor
Institut Claudius Regaud
Collaborators
Fondation ARC
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1. Study Identification

Unique Protocol Identification Number
NCT05427461
Brief Title
Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma, Part 2
Acronym
SAMHY2
Official Title
Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma, Part 2
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2023 (Actual)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud
Collaborators
Fondation ARC

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leiomyosarcoma
Keywords
Leiomyosarcoma, 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
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient with leiomyosarcoma
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Blood samples will be collected at different times.
Intervention Description
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).
Primary Outcome Measure Information:
Title
The longitudinal evolution of rate of patients with "cancer cell / macrophage" hybrid cells in peripheral blood.
Time Frame
24 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
24 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 leiomyosarcoma. Diagnosis of sarcoma histologically confirmed by the RRePS network (Réseau de Référence en Pathologie des Sarcomes et des Viscères) Localized or metastatic disease Newly diagnosed patient who has not yet initiated specific treatment for sarcoma Age ≥ 18 years Patient affiliated to a Social Security system in France. Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedures Exclusion Criteria: Diagnosis of any other histological subtype of soft tissue sarcoma Associated pathology(ies) that may interfere with the study procedure Pregnant or breastfeeding woman 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. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thibaud VALENTIN
Phone
05 31 15 51 70
Email
valentin.thibaud@iuct-oncopole.fr
Facility Information:
Facility Name
Institut Universitaire du Cancer Toulouse - Oncopole
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibaud VALENTIN
Phone
05 31 15 51 70
Email
valentin.thibaud@iuct-oncopole.fr

12. IPD Sharing Statement

Learn more about this trial

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

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