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
  Purpose

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.


Condition
Cancer
Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Oncological Treatment During Pregnancy: Pharmacokinetics of Chemotherapy and Long Term Follow up of the Offspring

Resource links provided by NLM:


Further study details as provided by University Hospital, Gasthuisberg:

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 400
Study Start Date: August 2005
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

pregnant women diagnosed with cancer

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330447

Contacts
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

Locations
Belgium
UZ Gasthuisberg, Katholieke Universiteit Leuven Recruiting
Leuven, Belgium, 3000
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   
Sub-Investigator: Lieven Lagae, MD, PhD         
Sub-Investigator: Luc Mertens, MD, PhD         
Sub-Investigator: Jan de Hoon, MD, PhD Sci         
Principal Investigator: Frederic Amant, MD, PhD         
Sub-Investigator: Kristel Van Calsteren, MD         
Sub-Investigator: Nelleke Ottevanger, MD PhD         
Sub-Investigator: Michael Halaska, MD         
Sponsors and Collaborators
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.
Investigators
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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Frederic Amant, UZ Gasthuisberg, Katholieke Universiteit Leuven, Belgium
ClinicalTrials.gov Identifier: NCT00330447     History of Changes
Other Study ID Numbers: cancer in pregnancy
Study First Received: May 25, 2006
Last Updated: June 24, 2010
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by University Hospital, Gasthuisberg:
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

ClinicalTrials.gov processed this record on July 26, 2014