Effects of Oncological Treatment During Pregnancy on Mother and Child
Effects of Oncological Treatment During Pregnancy on Mother and Child
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).
Study contains several study parts (protocol version 4.2):

 **********Part I. Pregnancy, delivery and maternal health********** Part I.I.A. Registration
 study 'Cancer during pregnancy' mother and neonate None Part I.I.B. Effects of prenatal
 exposure to cancer treatment on fetal growth. The association between placental
 pathophysiologic mechanisms (histopathology and immunohistochemistry), circulating maternal
 factors and fetal growth.

 From participating women, a maternal blood sample will be collected during or shortly after
 birth. Also, an umbilical cord blood sample and placental and umbilical cord biopsies will be
 drawn.

 Part I.II. Measurement of maternal and paternal anxiety and emotional needs when confronted
 with a cancer diagnosis during pregnancy The participants will be asked to complete
 questionnaires. Part I.III. Biobank 'cancer and pregnancy' From participating women, a tumour
 biopsy specimen before administration of neoadjuvant therapy will be collected at the time of
 diagnosis. Also, maternal blood samples will be collected before and/or after treatment.

 Part I.IV. Study on the pharmacokinetics of chemotherapeutic agents in pregnant women
 Approximately 10-12 additional peripheral venous blood withdrawals.

 **********Part II. Child********** Long term follow up of children and adolescents in utero
 exposed to chemotherapy and/or radiotherapy Regular check-ups of the child, at the age of
 18months, 3y, 6y, 9y, 12y, 15y, and 18y, and after the age of 18 years: 5-yearly cardiologic
 assessment and questionnaires (23y, 28y, 33y, 38y, and 43y). Optional at the ages of 9y, 12y,
 15y and 18y: MRI session.

 Summary part I:

 Prospectively the outcome of mothers diagnosed and/or treated for cancer during pregnancy
 will be registered and investigated.

 Summary Part II:

 In a prospective trial we invite children that were exposed to cytotoxic drugs or
 radiotherapy in utero for a standardized neurological and cardiological examination. The
 examinations will be done by qualified psychologists, neurological and cardiological
 pediatricians.
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.

 Exclusion Criteria:

 -  Mentally disabled or significantly altered mental status that would prohibit the
 understanding and giving of informed consent