Effects of Oncological Treatment During Pregnancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2010 by University Hospital, Gasthuisberg
Sponsor:
Collaborators:
de Hoon, Jan, M.D. Ph.D. M.Sc.
Delforge, Michel, M.D., Ph.D.
Myriam Hanssens, MD PhD
Lagae, Lieven, M.D., Ph.D.
Mertens, Luc, M.D., Ph.D.
Paridaens, Robert, M.D., Ph.D.
Information provided by:
University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT00330447
First received: May 25, 2006
Last updated: June 24, 2010
Last verified: June 2010

May 25, 2006
June 24, 2010
August 2005
September 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00330447 on ClinicalTrials.gov Archive Site
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Effects of Oncological Treatment During Pregnancy
Oncological Treatment During Pregnancy: Pharmacokinetics of Chemotherapy and Long Term Follow up of the Offspring

The researchers aim to test the hypothesis that children who were exposed to cytotoxic drugs in utero, develop normally. Furthermore, they aim to test the pharmacokinetics of these drugs. Children who were exposed to radiotherapy during pregnancy will also be included.

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.

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.

Observational
Observational Model: Cohort
Not Provided
Retention:   Samples With DNA
Description:

serum and sediment of blood; from 2010 on we collect umbilical cord blood

Non-Probability Sample

pregnant women diagnosed with cancer

  • Cancer
  • Pregnancy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
April 2020
September 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact: Frederic Amant, MD, PhD +32-16-344634/5 frederic.amant@uz.kuleuven.ac.be
Contact: Kristel Van Calsteren, MD +32-16-346192 kristel.vancalsteren@uz.kuleuven.ac.be
Belgium
 
NCT00330447
cancer in pregnancy
No
Frederic Amant, UZ Gasthuisberg, Katholieke Universiteit Leuven, Belgium
University Hospital, Gasthuisberg
  • de Hoon, Jan, M.D. Ph.D. M.Sc.
  • Delforge, Michel, M.D., Ph.D.
  • Myriam Hanssens, MD PhD
  • Lagae, Lieven, M.D., Ph.D.
  • Mertens, Luc, M.D., Ph.D.
  • Paridaens, Robert, M.D., Ph.D.
Study Chair: Luc Mertens, MD, PhD Pediatric Cardiology
Study Chair: Lieven Lagae, MD, PhD Pediatric Neurology
Study Chair: Jan de Hoon, MD, PhD Sci Clinical Pharmacology
University Hospital, Gasthuisberg
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP