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Effects of Oncological Treatment During Pregnancy

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ClinicalTrials.gov Identifier: NCT00330447
Recruitment Status : Recruiting
First Posted : May 26, 2006
Last Update Posted : November 21, 2016
Sponsor:
Collaborators:
Laurence Claes, PhD
Ingrid Boere, MD PhD
Michael Halaska, MD PhD
Lagae, Lieven, M.D., Ph.D.
Mertens, Luc, M.D., Ph.D.
Monica Fumagalli, MD PhD
Information provided by (Responsible Party):
Frederic Amant, University Hospital, Gasthuisberg

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The researchers aim to investigate the outcome (overall survival) of mothers who are diagnosed and/or treated for cancer during pregnancy. Furthermore they want to test the hypothesis that children who were exposed to cytotoxic drugs in utero, or radiotherapy, develop normally (neurologic and cardiologic examination).

Condition or disease
Cancer Pregnancy

Detailed Description:

Prospectively the outcome of mothers diagnosed and/or treated for cancer during pregnancy will be registered and investigated.

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.


Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 18 Years
Official Title: Oncological Treatment During Pregnancy: Pharmacokinetics of Chemotherapy and Long Term Follow up of the Offspring
Study Start Date : August 2005
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : April 2025
Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Studygroup
Cancer in Pregnancy - all diagnoses and treatments Children born from mothers diagnosed with cancer during pregnancy
Control group
Children from the general population


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Follow-up of the mothers diagnosed with cancer during pregnancy [ Time Frame: anticipated ]
    Overall survival

  2. Follow-up of the children antenatally exposed to chemotherapy or radiotherapy [ Time Frame: anticipated ]
    neurologic and cardiologic outcome


Biospecimen Retention:   None Retained
serum and sediment of blood; from 2010 on we collect umbilical cord blood

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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 during pregnancy
  • 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330447


Contacts
Contact: Liesbeth Leemans +32-16-344634/5 Liesbeth.leemans@uzleuven.be
Contact: Kristel Van Calsteren, MD PhD +32-16-346192 kristel.vancalsteren@uzleuven.be

Locations
Belgium
UZ Gasthuisberg, Katholieke Universiteit Leuven Recruiting
Leuven, Belgium, 3000
Contact: Frederic Amant, MD, PhD    +32-16-344252    frederic.amant@uzleuven.be   
Contact: Kristel Van Calsteren, MD, PhD    +32-16-346192    kristel.vancalsteren@uzleuven.be   
Sub-Investigator: Lieven Lagae, MD, PhD         
Sub-Investigator: Luc Mertens, MD, PhD         
Principal Investigator: Frederic Amant, MD, PhD         
Sub-Investigator: Kristel Van Calsteren, MD         
Sub-Investigator: Ingrid Boere, MD PhD         
Sub-Investigator: Michael Halaska, MD         
Sub-Investigator: Laurence Claes, PhD         
Sub-Investigator: Monica Fumagalli, MD PhD         
Sponsors and Collaborators
University Hospital, Gasthuisberg
Laurence Claes, PhD
Ingrid Boere, MD PhD
Michael Halaska, MD PhD
Lagae, Lieven, M.D., Ph.D.
Mertens, Luc, M.D., Ph.D.
Monica Fumagalli, MD PhD
Investigators
Principal Investigator: Amant Frederic, MD PhD KULeuven, Belgium
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional 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

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Frederic Amant, MD PhD, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT00330447     History of Changes
Other Study ID Numbers: cancer in pregnancy
First Posted: May 26, 2006    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016

Keywords provided by Frederic Amant, 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