NCT04818125

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

March 31, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2022

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

1.3 years

First QC Date

March 24, 2021

Last Update Submit

September 27, 2022

Conditions

Breast Cancer

Keywords

Breast CancerCancer cell/macrophage hybrid cellsHybrid cells

Outcome Measures

Primary Outcomes (1)

  • 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.

    20 months after the study start

Secondary Outcomes (2)

  • Quantification of circulating hybrid cells in peripheral blood by automatic measurement (Cell Counter Corning) and expressed in number of cells / millilitre of blood.

    20 months after the study start

  • Progression-free survival (PFS) defined as the time from the date of inclusion to the date of progression or death from any cause.

    20 months after the study start

Study Arms (1)

Patients with breast cancer

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

Interventions

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

Patients with breast cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2021

First Posted

March 26, 2021

Study Start

March 31, 2021

Primary Completion

July 29, 2022

Study Completion

July 29, 2022

Last Updated

September 28, 2022

Record last verified: 2022-09

Locations

FR(1)