To obtain a fundamental understanding if and which chemotherapeutic agents used for treating cancer during pregnancy are associated with offspring (epi)genetic changes, potentially causing FGR and childhood/adult diseases later in life.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
determination of potential (sub)chromosomal alterations and/or changes in DNA
methylation in cord blood and buccal cells of the newborn, and the association
with chemotherapy concentrations measured in respectively placental or newborn
tissue.
Secondary outcome
not applicable
Background summary
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 chemotherapeutic cancer treatment in pregnancy has reassuring
outcomes in terms of cognitive and cardiac neonatal outcomes, and hence has
been proposed as standard of care [1-3]. However fetal growth restriction
(FGR), which places an infant at significant risk of perinatal morbidity and
mortality, is more common in women who were systemically treated during
pregnancy compared to the non-cancer population. The possibility that
chemotherapy during pregnancy causes placental (epi)genetic damage, and
consequently induces FGR, or affects offspring DNA leading to potential
deleterious effects later in life, such as cancer or other diseases, has not
been investigated so far. As the cytotoxic effects of chemotherapy at DNA level
have been well established, it could be speculated that chemotherapy-induced
DNA damage may interfere with fetal and childhood health in the long term. The
results of this study will lead to an increased understanding of potential
toxic effects of chemotherapy for the unborn child and may therefore contribute
to the development of safe and solid treatment regimens for pregnant cancer
patients and their children.
Study objective
To obtain a fundamental understanding if and which chemotherapeutic agents used
for treating cancer during pregnancy are associated with offspring (epi)genetic
changes, potentially causing FGR and childhood/adult diseases later in life.
Study design
This international multicentre prospective observational trial functions as an
extension of the CIP-study (Cancer in Pregnancy, S25470) and aims to collect
placental tissue, cord blood and meconium and neonatal buccal cells at birth.
Parental peripheral blood and buccal cells will be collected and used as
reference. Minimal requirement to participate in this study is participation in
CIP-study. Through this CIP-study we are able to gather pregnancy-, malignancy-
and placenta-related data.
Study burden and risks
There are no risks associated with participation in this study.
Herestraat 49
Leuven B3000
BE
Herestraat 49
Leuven B3000
BE
Listed location countries
Age
Inclusion criteria
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
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)
Design
Recruitment
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76873.018.21 |