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

18 Years
Open (Enrolling)
Cancer, Pregnancy

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Trial Information

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

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

For the pharmacological part we will sample maternal blood after infusion of cytotoxic
drugs. Samples will be analysed at the department of Clinical Pharmacology and results will
be compared with the non-pregnant state.

Inclusion Criteria:

Patients must meet all of the following inclusion criteria:

- Histologically proven cancer

- Patients must have adequate bone marrow, renal, hepatic and pulmonary function.

- World Health Organization (WHO) performance status of 0 or 1

- > 18 years of age

- 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 during pregnancy are allowed for the assessment of
the maternal and fetal outcome

- Patients are allowed to opt for the pharmacokinetic part or clinical follow-up part
of the study only and do not need to participate in both; however, preferentially
both study parts should be performed.

- Women receiving any kind of radiotherapy during pregnancy

Exclusion Criteria:

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

Type of Study:


Study Design:

Observational Model: Cohort

Principal Investigator

Luc Mertens, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Pediatric Cardiology


Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

cancer in pregnancy



Start Date:

August 2005

Completion Date:

April 2020

Related Keywords:

  • Cancer
  • Pregnancy
  • 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