Effects of Oncological Treatment During Pregnancy
This study is currently recruiting participants.
Verified June 2010 by University Hospital, Gasthuisberg
Sponsor:
University Hospital, Gasthuisberg
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
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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
Detailed Description:
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) |
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
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 June 18, 2013