Circulating Fetal Cells and Breast Cancer

Breast Cancer Clinical Trial

— MoSaiC2  

Official title:

Fetal Microchimerism and Fetal Stem Cells in Breast Cancer: Analysis of Circulating Fetal Cell Sub-populations in Women With Breast Cancer. CIRCULATING FETAL CELLS AND BREAST CANCER

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04903990
• Other study ID #: APHP190505
• Secondary ID: 2019-A00703-54
• Status: Active, not recruiting
• Start date: May 14, 2021
• Est. completion date: May 2025

Study information

• Verified date: April 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

After pregnancy, fetal cells remain in a woman's body for years. These cells may be involved in different physiological situations (e.g. wound healing) and diseases (e.g. cancer).The study will evaluate the level of circulating fetal immune cells in patients with breast cancer vs controls with benign breast tumors, and further characterize these fetal cells. Patients participation will be limited to accepting that an additional blood sample is collected on the day of their preop consultation and blood test.

Description:

Breast cancer is the most common cancer in the female population. The protective mechanism associated with pregnancy is not fully understood.

During pregnancy fetal cells cross the placental barrier and may remain in the maternal circulation even for up to 30 years after childbirth. This phenomenon is called fetal microchimerism.

The presence of circulating fetal cells would have a protective role against breast cancer. However, their phenotype and role in the anti-tumor response is not explored.

The objective of the study is to identify the sub-population (s) of circulating fetal immune cells that may have an impact on the processes of carcinogenesis in breast cancer, in the context of fetal microchimerism.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• women aged 18-50

• having had a male child

• informed and not having objected to participating in the research.

Patients:

• having a diagnosis of breast cancer

Controls:

• operated on for benign breast tumors

• cancer free

Exclusion Criteria:

• autoimmune disease

• immunomodulatory treatment

• history of cancer other than breast cancer

• ongoing hormonal treatment

• women not affiliated to the social security

• under AME (state medical aid)

• under tutorship / curatorship

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Blood sample
As part of the treatment, 2 EDTA tubes of 10mL will be taken during a scheduled venipuncture as part of the preoperative assessment.

Locations

Country	Name	City	State
France	Hôpital de Tenon-Service de Gynécologie Obstétrique et Médecine de la Reproduction	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ruban Rose

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentages of fetal cells in each immune cell subpopulation.	Using fluorescence activated cell sorting method.	3 years
Secondary	Activation markers.	Using immunocytochemistry method.	3 years
Secondary	Cytotoxicity markers.	Using immunocytochemistry method.	3 years