Circulating Fetal Cells and Breast Cancer
MoSaiC2
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
2 other identifiers
observational
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 14, 2021
CompletedFirst Submitted
Initial submission to the registry
May 17, 2021
CompletedFirst Posted
Study publicly available on registry
May 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedJune 16, 2021
April 1, 2021
4 years
May 17, 2021
June 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentages of fetal cells in each immune cell subpopulation.
Using fluorescence activated cell sorting method.
3 years
Secondary Outcomes (2)
Activation markers.
3 years
Cytotoxicity markers.
3 years
Study Arms (2)
Patients
women 18-50 years * with previous history of a male birth * scheduled for malignant breast tumor surgery
Controls
women 18-50 years * with previous history of a male birth * scheduled for benign breast tumor surgery * or cancer free
Interventions
As part of the treatment, 2 EDTA tubes of 10mL will be taken during a scheduled venipuncture as part of the preoperative assessment.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique - Hôpitaux de Parislead
- Ruban Rosecollaborator
Study Sites (1)
Hôpital de Tenon-Service de Gynécologie Obstétrique et Médecine de la Reproduction
Paris, 75020, France
Biospecimen
Blood sample for quantification and characterization of fetal blood stem cells.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathalie CHABBERT-BUFFET, PUPH
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2021
First Posted
May 27, 2021
Study Start
May 14, 2021
Primary Completion
May 1, 2025
Study Completion
May 1, 2025
Last Updated
June 16, 2021
Record last verified: 2021-04