Clinical trial · Observational
Genomic and Epigenomic Alterations After Cancer Treatment in Pregnancy
NCT04125446CI-TRIAL-00061044GE-CIPunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Pregnancy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Cancer in pregnancy chemo treated
- description
- Patients that received at least one of the following treatments: Carboplatin, Cisplatin, Cyclophosphamide, Paclitaxel and/or anthracyclines, the latter being the most given type of CT during pregnancy
- label
- Cancer in Pregnancy not chemo treated
- description
- Women who were not treated with CT during pregnancy, including those who were solely surgically treated or did not receive any treatment during pregnancy, will be included in the CT-unexposed control arm
- label
- healthy pregnancies
- description
- A group of healthy pregnant women without cancer will form the second control group
Primary outcomes (1)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.