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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05427461
Recruitment Status : Recruiting
First Posted : June 22, 2022
Last Update Posted : January 19, 2023
Sponsor:
Collaborator:
Fondation ARC
Information provided by (Responsible Party):
Institut Claudius Regaud

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. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : January 13, 2023
Estimated Primary Completion Date : July 2026
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. 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 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. [ Time Frame: 24 months after the end of inclusions. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05427461


Contacts
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Contact: Thibaud VALENTIN 05 31 15 51 70 valentin.thibaud@iuct-oncopole.fr

Locations
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France
Institut Universitaire du Cancer Toulouse - Oncopole Recruiting
Toulouse, France, 31059
Contact: Thibaud VALENTIN    05 31 15 51 70    valentin.thibaud@iuct-oncopole.fr   
Sponsors and Collaborators
Institut Claudius Regaud
Fondation ARC
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Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT05427461    
Other Study ID Numbers: 22 SARC 03
First Posted: June 22, 2022    Key Record Dates
Last Update Posted: January 19, 2023
Last Verified: January 2023

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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:
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Leiomyosarcoma
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Muscle Tissue