Circulating Fetal Cells and Breast Cancer

NCT ID: NCT04903990

Last Updated: 2021-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-14
• Study Completion Date: 2025-05-31

Brief 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.

Detailed 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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

women 18-50 years

• with previous history of a male birth
• scheduled for malignant breast tumor surgery

Blood sample

Intervention Type: OTHER

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

Controls

women 18-50 years

• with previous history of a male birth
• scheduled for benign breast tumor surgery
• or cancer free

Blood sample

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ruban Rose

UNKNOWN

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathalie CHABBERT-BUFFET, PUPH

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital de Tenon-Service de Gynécologie Obstétrique et Médecine de la Reproduction

Paris, , France

Countries

France

Other Identifiers

2019-A00703-54

Identifier Type: OTHER

Identifier Source: secondary_id

APHP190505

Identifier Type: -

Identifier Source: org_study_id