Effects of Oncological Treatment During Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00330447
Recruitment Status : Recruiting
First Posted : May 26, 2006
Last Update Posted : November 21, 2016
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

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 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

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

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

Information from the National Library of Medicine

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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

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

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 identifier (NCT number): NCT00330447

Contact: Liesbeth Leemans +32-16-344634/5
Contact: Kristel Van Calsteren, MD PhD +32-16-346192

UZ Gasthuisberg, Katholieke Universiteit Leuven Recruiting
Leuven, Belgium, 3000
Contact: Frederic Amant, MD, PhD    +32-16-344252   
Contact: Kristel Van Calsteren, MD, PhD    +32-16-346192   
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
Principal Investigator: Amant Frederic, MD PhD KULeuven, Belgium

Additional Information:
Publications of Results:

Other Publications:

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Frederic Amant, MD PhD, University Hospital, Gasthuisberg 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:
in utero
long term
follow up
cancer during pregnancy
chemotherapy and radiotherapy during pregnancy
long term follow up of children