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
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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