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Effects of Oncological Treatment During Pregnancy on Mother and Child
Oncological Treatment During Pregnancy: Pharmacokinetics of Chemotherapy and Long Term Follow up of the Offspring
Who can join
Ages 18 and older · Women · Healthy volunteers welcome
Full eligibility criteria
Patients do not need to participate in both; however, preferentially both study parts should be performed. \*\*\*\*\*\*\*\*\*\*\*\*\*\*Part I: Pregnancy, delivery and maternal health\*\*\*\*\*\*\*\*\*\*\*\*\*\* Patients must meet the following inclusion criteria: * Histologically proven cancer in association with a pregnancy (during pregnancy or cancer dagnosis within 5 years after pregnancy) * \> 18 years of age, premenopausal * Patients who have given their signed and written informed consent to participate in the trial after fully understanding the implication of the protocol * Women receiving any cytotoxic drug or radiation therapy during pregnancy are allowed for the assessment of the maternal and fetal outcome (Part II). Exclusion Criteria: * Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent \*\*\*\*\*\*\*\*\*\*\*\*\*\*Part II: Follow-up of children\*\*\*\*\*\*\*\*\*\*\*\*\*\* Inclusion Criteria: \- Children that were prenatally exposed to cancer of cancer treament. Informed Consent is asked from parents. From the age of 12 years, informed assent is additionally asked from the child. After the age of 18 years, informed consent is solely asked of the offspring. Exclusion Criteria: * Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent
About the study
The researchers aim to investigate the outcome (overall survival) of mothers who are diagnosed and/or treated for cancer during pregnancy. Furthermore they want to test the hypothesis that children who were exposed to cancer or cancer treatment (cytotoxic drugs, radiation therapy, targeted therapy,...) develop normally (neurologic and cardiologic examination).
Sponsor: University Hospital, Gasthuisberg · Participants: 5,000 · Started: 2005-08
Contact the study team
- Ayaka Wakatsuki · Phone: +32 16 34 41 69
- Kristel Van Calsteren, MD PhD · Phone: +32-16-346192
Official record on ClinicalTrials.gov — NCT00330447
Locations in the U.S.
| New Jersey | Cooper University Hospital (2015-ongoing), Camden |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.