Status:
UNKNOWN
Genomic and Epigenomic Alterations After Cancer Treatment in Pregnancy
Lead Sponsor:
University Hospital, Gasthuisberg
Collaborating Sponsors:
University Hospital, Antwerp
University Hospital, Ghent
Conditions:
Cancer
Pregnancy
Eligibility:
All Genders
Brief Summary
The investigators want to obtain a fundamental understanding if and which chemotherapeutic agents used for treating cancer during pregnancy are associated with placental and/or offspring (epi)genetic ...
Detailed Description
Rationale: Cancer is the second leading cause of death during the reproductive years and affects between 1:1000 and 2000 pregnant women. Previous studies from our group have shown that chemotherapeuti...
Eligibility Criteria
Inclusion
- Cancer in pregnancy - CT-treated arm
- Histological proven cancer during pregnancy (any type and stage)
- (Former) participation in part I.IA of the CIP-study S25470 (and I.IB for the placental sub study)
- Treatment during pregnancy with one or a combination of the following chemotherapeutic agents:
- Cyclophosphamide
- Anthracyclines
- Taxanes
- Platinum derivates
- Gestational age (GA) at birth ≥24 weeks Cancer in pregnancy - CT-untreated arm
- No treatment during pregnancy or surgery only (subgroup 1)
- Radiotherapy and/or systemic treatment (other than CT) during pregnancy (subgroup 2)
- GA at birth ≥24 weeks Healthy pregnant controls
- matched for maternal age, gestation at birth and infant gender with CT-treated arm
- GA at birth ≥24 weeks (only for placental study)
Exclusion
- GA at birth \<24 weeks (miscarriage or termination of pregnancy) (placental study)
- Mentally disabled women or patients who have a significantly altered mental status that would prohibit the understanding and giving of informed consent
- Any comorbidity that is associated with an enhanced risk of placental pathology or FGR such as hypertensive disorders, preeclampsia, (gestational) diabetes, SLE, Crohn's disease, renal or cardiac pathology (healthy pregnant controls)
Key Trial Info
Start Date :
October 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04125446
Start Date
October 15 2019
End Date
December 31 2023
Last Update
September 27 2022
Active Locations (1)
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1
University Hospitals Leuven
Leuven, Belgium, 3000