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Immune checkpoint inhibitors (ICIs), such as anti-PD-1/PD-L1 agents, initially evaluated in advanced non-curative pathologies, are now being evaluated in adjuvant or even neoadjuvant curative treatment conditions. This paradigm shift is leading to the treatment of young women, particularly in the context of gestational trophoblastic tumours. Given the potential autoimmune side-effects affecting endocrine functions, as well as their impact on maternal-foetal tolerance mechanisms, accurate assessment of post-ICT fertility is necessary. In the coming years, treatment with anti-PD-L1 (avelumab) could become a cornerstone of the therapeutic strategy for patients with gestational trophoblastic tumours.
However, these patients are often young and of childbearing age, so safety of use in terms of fertility and successful pregnancies is an essential factor in the widespread use of immunotherapy as a treatment option. Some studies have reported the possibility of conceiving after avelumab treatment, but no cohort has been reported. This study aims to explore fertility and the course of potential pregnancy in 50 patients treated with anti-PD-L1 (avelumab) over the last 5 years in several French centres.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Female patients with gestational trophoblastic tumour. | Other | Female patients treated in phase II or III clinical trials: TROPHIMMUN and TROPHAMET or who have received AVELUMAB outside the trial for a gestational trophoblastic tumour. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone interview | Other | Collection of gynaecology-obstetrics data on patients treated with AVELUMAB |
|
| Measure | Description | Time Frame |
|---|---|---|
| Describe the time to pregnancy in patients treated with anti PDL1 (avelumab) for GTT | Time to achieve pregnancy after stopping contraception | Up to 5 years |
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Inclusion Criteria :
Exclusion Criteria :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre-Adrein BOLZE, ¨Pr | Contact | 04 78 86 66 78 | +33 | pierre-adrien.bolze@chu-lyon.fr |
| Adrien MSIKA | Contact | adrien.msika@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre De Reference Des Maladies Trophoblastiques, Hôpital Lyon Sud | Pierre-Bénite | 69310 | France |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Prospective and retrospective cohort
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |