Genomic and Epigenomic Alterations After Cancer Treatment in Pregnancy (NCT04125446) | Clinical Trial Compass
UnknownNot Applicable
Genomic and Epigenomic Alterations After Cancer Treatment in Pregnancy
Belgium150 participantsStarted 2019-10-15
Plain-language 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 changes, potentially causing FGR and childhood/adult diseases later in life.
Who can participate
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Inclusion Criteria:
* 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 Criteria:
* 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)
What they're measuring
1
Assessing general genotoxicity of fetal DNA; genomic instability, de novo somatic mutations and methylation changes related to in utero exposure to chemotherapy
Timeframe: through study completion, an average of 5 years