MoSaiC2: Circulating Fetal Cells and Breast Cancer

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04903990
Collaborator
Ruban Rose (Other)
80
1
47.6
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood sample

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 Design

Study Type:
Observational
Actual Enrollment :
80 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
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
Actual Study Start Date :
May 14, 2021
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Percentages of fetal cells in each immune cell subpopulation. [3 years]

    Using fluorescence activated cell sorting method.

Secondary Outcome Measures

  1. Activation markers. [3 years]

    Using immunocytochemistry method.

  2. Cytotoxicity markers. [3 years]

    Using immunocytochemistry method.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital de Tenon-Service de Gynécologie Obstétrique et Médecine de la Reproduction Paris France 75020

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris
  • Ruban Rose

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT04903990
Other Study ID Numbers:
  • APHP190505
  • 2019-A00703-54
First Posted:
May 27, 2021
Last Update Posted:
Jun 16, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Assistance Publique - Hôpitaux de Paris
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 16, 2021