Actively Recruiting
Oncological Treatment During Pregnancy Pharmacokinetics of Chemotherapy and Long Term Follow-up of the Offspring
Led by University Hospital, Gasthuisberg · Updated on 2024-03-06
5000
Participants Needed
33
Research Sites
400 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Gasthuisberg
Lead Sponsor
T
The Netherlands Cancer Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the outcomes for mothers diagnosed with cancer during pregnancy, focusing on overall survival and the long-term development of children exposed to cancer or cancer treatments before birth. The study aims to understand how prenatal exposure to therapies like chemotherapy, radiation, or targeted treatments may affect childrens neurological and heart health as they grow. The study includes several parts initially, it registers and tracks maternal and neonatal health during pregnancy and delivery, including collecting blood samples and tissue biopsies. Emotional needs of parents facing a cancer diagnosis are assessed through questionnaires. The second part follows children exposed in utero to cancer treatments with regular check-ups at various ages up to adulthood, including neurological and cardiological exams, and optional MRI sessions. Participants will undergo scheduled assessments including blood sample collection, placental biopsies, and questionnaires for parents. Children will have neurological and heart evaluations at set ages from 6 months through 18 years, with further cardiologic monitoring every five years into adulthood. The research team monitors overall survival in mothers and developmental outcomes in children, ensuring comprehensive long-term follow-up extending potentially into the fourth decade of life for offspring.
CONDITIONS
Brief Title
Effects of Oncological Treatment During Pregnancy on Mother and Child
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged over 18 years, premenopausal
- Histologically confirmed cancer during pregnancy or cancer diagnosis within 5 years after pregnancy
- Signed informed consent after understanding the study
- Women receiving any cytotoxic drug or radiation therapy during pregnancy are allowed for maternal and fetal outcome assessment
- Children prenatally exposed to cancer or cancer treatment with parental consent; from age 12 years, child assent is also requested; from age 18, informed consent is from the offspring
You will not qualify if you...
- Mentally disabled or significantly altered mental status that would prevent understanding and giving informed consent
Research Team
A
Ayaka Wakatsuki
K
Kristel Van Calsteren, MD PhD
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