Genomic and Epigenomic alterations after Cancer treatment In Pregnancy.
- Conditions
- chemo therapyPregnancy1002765510028920
- Registration Number
- NL-OMON51958
- Lead Sponsor
- Z Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
ancer in pregnancy - CT-treated arm (n=150)
• 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 (n=150)
• 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
Exclusion criteria for the three study groups
• GA at birth <24 weeks (miscarriage or termination of pregnancy)
• 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)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>determination of potential (sub)chromosomal alterations and/or changes in DNA<br /><br>methylation in cord blood and buccal cells of the newborn, and the association<br /><br>with chemotherapy concentrations measured in respectively placental or newborn<br /><br>tissue.</p><br>
- Secondary Outcome Measures
Name Time Method <p>not applicable</p><br>