Effects of Oncological Treatment During Pregnancy - Full Text View

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

MedlinePlus related topics:

Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Other

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

Further study details as provided by University Hospital, Gasthuisberg:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

serum and sediment of blood

Estimated Enrollment:	100
Study Start Date:	August 2005
Estimated Study Completion Date:	April 2020

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:	No
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

Sponsors and Collaborators

University Hospital, Gasthuisberg

Jan de Hoon, MD PhD M Sc

Delforge, Michel, M.D., Ph.D.

Myriam Hanssens, MD PhD FRCOG

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

This site provides background information on the problem of cancer in pregnancy and details further the project. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Caluwaerts S, VAN Calsteren K, Mertens L, Lagae L, Moerman P, Hanssens M, Wuyts K, Vergote I, Amant F. Neoadjuvant chemotherapy followed by radical hysterectomy for invasive cervical cancer diagnosed during pregnancy: report of a case and review of the literature. Int J Gynecol Cancer. 2006 Mar-Apr;16(2):905-8.

Van Calsteren K, Berteloot P, Hanssens M, Vergote I, Amant F, Ganame J, Claus P, Mertens L, Lagae L, Delforge M, Paridaens R, Noens L, Humblet Y, Vandermeersch B, De Muylder X. In utero exposure to chemotherapy: effect on cardiac and neurologic outcome. J Clin Oncol. 2006 Apr 20;24(12):e16-7. No abstract available.

Responsible Party:	UZ Gasthuisberg, Katholieke Universiteit Leuven, Belgium ( Frederic Amant )
Study ID Numbers:	cancer in pregnancy
First Received:	May 25, 2006
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00330447
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

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 October 03, 2008

Sponsors and Collaborators:	University Hospital, Gasthuisberg Jan de Hoon, MD PhD M Sc Delforge, Michel, M.D., Ph.D. Myriam Hanssens, MD PhD FRCOG 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