Circulating Fetal Cells and Breast Cancer (MoSaiC2)

June 15, 2021 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75020
        • Hôpital de Tenon-Service de Gynécologie Obstétrique et Médecine de la Reproduction

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The study population includes only women who have had a male child, premenopausal, aged 18-50 years, who are operated on for breast cancer or who have just been diagnosed with breast cancer.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients

women 18-50 years

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

women 18-50 years

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentages of fetal cells in each immune cell subpopulation.
Time Frame: 3 years
Using fluorescence activated cell sorting method.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activation markers.
Time Frame: 3 years
Using immunocytochemistry method.
3 years
Cytotoxicity markers.
Time Frame: 3 years
Using immunocytochemistry method.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Ruban Rose

Investigators

  • Principal Investigator: Nathalie CHABBERT-BUFFET, PUPH, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 14, 2021

Primary Completion (ANTICIPATED)

May 1, 2025

Study Completion (ANTICIPATED)

May 1, 2025

Study Registration Dates

First Submitted

May 17, 2021

First Submitted That Met QC Criteria

May 21, 2021

First Posted (ACTUAL)

May 27, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 16, 2021

Last Update Submitted That Met QC Criteria

June 15, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP190505
  • 2019-A00703-54 (OTHER: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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