Breast CancerMoSaiC2NCT04903990
Circulating Fetal Cells and Breast Cancer
An observational study of Breast Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Blood sample
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 14 May 2021to May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital de Tenon-Service de Gynécologie Obstétrique et Médecine de la Reproduction
Paris, 75020
About this study
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
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.
Read the 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
- Being tested
- Blood sample
- Keywords
- Breast cancer, Microchimerism, Hematopietic fetal cells
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
As part of the treatment, 2 EDTA tubes of 10mL will be taken during a scheduled venipuncture as part of the preoperative assessment.
| Study group | Role | What they receive |
|---|---|---|
| Patients | women 18-50 years
* with previous history of a male birth
* scheduled for malignant breast tumor surgery Receives: Other: Blood sample | |
| Controls | women 18-50 years
* with previous history of a male birth
* scheduled for benign breast tumor surgery
* or cancer free Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentages of fetal cells in each immune cell subpopulation.
Using fluorescence activated cell sorting method.
Measured: 3 years
Secondary outcomes (2)
Activation markers.
Using immunocytochemistry method.
Measured: 3 years
Cytotoxicity markers.
Using immunocytochemistry method.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start14 May 2021
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ruban Rose
- Responsible party
- Sponsor
- Investigators
- Nathalie CHABBERT-BUFFET, PUPH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903990
- Sponsor's protocol ID
- APHP190505
- Other IDs
- 2019-A00703-54
- Acronym
- MoSaiC2
- Status last verified
- Apr 2021
- First submitted
- 17 May 2021
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04903990
- Acronym / sponsor ID
- MoSaiC2 / APHP190505
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Microchimerism, Hematopietic fetal cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ruban Rose
- Study start
- 14 May 2021 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Blood samplewomen 18-50 years * with previous history of a male birth * scheduled for malignant breast tumor surgery |
| Controls | – | Other: Blood samplewomen 18-50 years * with previous history of a male birth * scheduled for benign breast tumor surgery * or cancer free |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (8 listed)
- women aged 18-50
- having had a male child
- informed and not having objected to participating in the research.
- having a diagnosis of breast cancer
- operated on for benign breast tumors
Key exclusion criteria (7 listed)
- autoimmune disease
- immunomodulatory treatment
- history of cancer other than breast cancer
- ongoing hormonal treatment
- women not affiliated to the social security
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleAs part of the treatment, 2 EDTA tubes of 10mL will be taken during a scheduled venipuncture as part of the preoperative assessment. | Other | Controls, Patients |
Primary outcome
Percentages of fetal cells in each immune cell subpopulation.
Time frame: 3 years
Using fluorescence activated cell sorting method.
2 secondary outcomes
Activation markers.
Time frame: 3 years
Cytotoxicity markers.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie CHABBERT-BUFFET, PUPH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentages of fetal cells in each immune cell subpopulation. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021; AzTrials last refreshed its copy on 6 Nov 2026.