Effects of Oncological Treatment During Pregnancy on Mother and Child

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Oncological Treatment During Pregnancy: Pharmacokinetics of Chemotherapy and Long Term Follow up of the Offspring

Conditions
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Cancer, Pregnancy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Studygroup<br>Cancer in Pregnancy - all diagnoses and treatments Children born from mothers diagnosed with cancer during pregnancy | |
| Control group<br>Children from the general population | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follow-up of the mothers diagnosed with cancer during pregnancy | treatment during pregnancy, obstetrical outcome, maternal survival | anticipated | 
| Follow-up of the children antenatally exposed to chemotherapy or radiotherapy | neurologic and cardiologic outcome | anticipated | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, in utero, chemotherapy, radiotherapy, cancer, offspring, neonatal, long term, follow up, cancer during pregnancy, chemotherapy and radiotherapy during pregnancy, long term follow up of children