Circulating Cancer Cells/Macrophage HYbrid Cells in Patients With Breast Cancer.

NCT ID: NCT04818125

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2022-07-29

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with breast cancer

Group Type: OTHER

Patients with breast cancer (stage I, II III or IV)

Intervention Type: OTHER

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.

Interventions

Patients with breast cancer (stage I, II III or IV)

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 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).

2. Patient not yet initiated on specific treatment for the stage of breast cancer at inclusion.

3. Available tumor sample (archived tumor block) : initial tumor or metastasis depending on the stage of the disease and availability.

4. Age ≥ 18 years old.

5. Patient affiliated to a Social Health Insurance in France.

6. Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedure.

Exclusion Criteria

1. Associated pathology(ies) that may prevent the proper conduct of the procedure under consideration.

2. Pregnant or breastfeeding woman.

3. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.

4. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship protection of justice).

5. Patient who has presented another solid tumor (except breast or cervix carcinoma in situ) within 5 years.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Claudius Regaud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, , France

Countries

France

Other Identifiers

21 SEIN 01

Identifier Type: -

Identifier Source: org_study_id