Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma? (SAMHY SARCOME)

December 9, 2021 updated by: Institut Claudius Regaud

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • Institut Universitaire du Cancer de Toulouse - Oncopole

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Patients with sarcoma
Other: Blood samples will be collected at two times :
  • at Baseline,
  • after surgery or at the time of post-chemotherapy evaluation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of patients with "cancer cell / macrophage" hybrid cells in peripheral blood.
Time Frame: 6 months after the end of inclusions
6 months after the end of inclusions

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months after the end of inclusions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 22, 2020

Primary Completion (ACTUAL)

December 2, 2021

Study Completion (ACTUAL)

December 2, 2021

Study Registration Dates

First Submitted

August 7, 2020

First Submitted That Met QC Criteria

August 11, 2020

First Posted (ACTUAL)

August 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 10, 2021

Last Update Submitted That Met QC Criteria

December 9, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20 SARC 04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sarcoma

Clinical Trials on Blood samples will be collected at two times :

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe