Back to resultsCirculating Cancer Cells/Macrophage HYbrid Cells in Patients With Breast Cancer. (CARMMYC)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patients with breast cancer (stage I, II III or IV)
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer focused on measuring Breast Cancer, Cancer cell/macrophage hybrid cells, Hybrid cells
Eligibility Criteria
Inclusion Criteria:
- Patient with breast cancer of any stage (stage I, II, III or IV) and any immunohistochemical subtype (triple-negative, HR+/HER2-negative or HER2-positive).
- Patient not yet initiated on specific treatment for the stage of breast cancer at inclusion.
- Available tumor sample (archived tumor block) : initial tumor or metastasis depending on the stage of the disease and availability.
- Age ≥ 18 years old.
- 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 procedure.
Exclusion Criteria:
- Associated pathology(ies) 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).
- Patient who has presented another solid tumor (except breast or cervix carcinoma in situ) within 5 years.
Sites / Locations
- Institut Universitaire du Cancer de Toulouse - Oncopole
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with breast cancer
Arm Description
Outcomes
Primary Outcome Measures
Rate of patients with cancer cell / macrophage hybrid cells in peripheral blood defined as the ratio of the number of patients with hybrid cells to the total number of patients.
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.
Progression-free survival (PFS) defined as the time from the date of inclusion to the date of progression or death from any cause.
Full Information
NCT ID
NCT04818125
First Posted
March 24, 2021
Last Updated
September 27, 2022
Sponsor
Institut Claudius Regaud
1. Study Identification
Unique Protocol Identification Number
NCT04818125
Brief Title
Circulating Cancer Cells/Macrophage HYbrid Cells in Patients With Breast Cancer.
Acronym
CARMMYC
Official Title
Circulating Cancer Cells/Macrophage HYbrid Cells in Patients With Breast Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 31, 2021 (Actual)
Primary Completion Date
July 29, 2022 (Actual)
Study Completion Date
July 29, 2022 (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 breast cancer (regardless of stage of the disease and the immunohistochemical subtype).
For each included patient, blood samples will be taken and tumor specimens will be collected for the study.
At the end of the 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
Breast Cancer
Keywords
Breast Cancer, 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
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with breast cancer
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Patients with breast cancer (stage I, II III or IV)
Intervention Description
Blood samples will be collected at different times:
at Baseline for all patients with breast cancer: before initiation of treatment (i.e. before initiation of planned treatment for stage I to III patients and before any new line of treatment for stage IV patients);
at the time of disease progression (or at 12 months in absence of progression) for patients with metastatic breast cancer (stage IV)
For each patient a tumor sample from the initial diagnosis of the disease (i.e. primary tumor +/- biopsy of a metastasis) will be collected (archived tumor block) for the study.
Primary Outcome Measure Information:
Title
Rate of patients with cancer cell / macrophage hybrid cells in peripheral blood defined as the ratio of the number of patients with hybrid cells to the total number of patients.
Time Frame
20 months after the study start
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
20 months after the study start
Title
Progression-free survival (PFS) defined as the time from the date of inclusion to the date of progression or death from any cause.
Time Frame
20 months after the study start
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with breast cancer of any stage (stage I, II, III or IV) and any immunohistochemical subtype (triple-negative, HR+/HER2-negative or HER2-positive).
Patient not yet initiated on specific treatment for the stage of breast cancer at inclusion.
Available tumor sample (archived tumor block) : initial tumor or metastasis depending on the stage of the disease and availability.
Age ≥ 18 years old.
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 procedure.
Exclusion Criteria:
Associated pathology(ies) 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).
Patient who has presented another solid tumor (except breast or cervix carcinoma in situ) within 5 years.
Facility Information:
Facility Name
Institut Universitaire du Cancer de Toulouse - Oncopole
City
Toulouse
Country
France
12. IPD Sharing Statement
Learn more about this trial
Circulating Cancer Cells/Macrophage HYbrid Cells in Patients With Breast Cancer.
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