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Effects of Oncological Treatment During Pregnancy

This study is currently recruiting participants.
Verified November 2016 by Frederic Amant, University Hospital, Gasthuisberg
Sponsor:
ClinicalTrials.gov Identifier:
NCT00330447
First Posted: May 26, 2006
Last Update Posted: November 21, 2016
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.
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
May 25, 2006
May 26, 2006
November 21, 2016
August 2005
April 2025   (Final data collection date for primary outcome measure)
  • Follow-up of the mothers diagnosed with cancer during pregnancy [ Time Frame: anticipated ]
    Overall survival
  • Follow-up of the children antenatally exposed to chemotherapy or radiotherapy [ Time Frame: anticipated ]
    neurologic and cardiologic outcome
Not Provided
Complete list of historical versions of study NCT00330447 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Effects of Oncological Treatment During Pregnancy
Oncological Treatment During Pregnancy: Pharmacokinetics of Chemotherapy and Long Term Follow up of the Offspring
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).

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.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
18 Years
Retention:   None Retained
Description:
serum and sediment of blood; from 2010 on we collect umbilical cord blood
Non-Probability Sample
pregnant women diagnosed with cancer
  • Cancer
  • Pregnancy
Not Provided
  • Studygroup
    Cancer in Pregnancy - all diagnoses and treatments Children born from mothers diagnosed with cancer during pregnancy
  • Control group
    Children from the general population
 
Recruiting
5000
April 2025
April 2025   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact: Liesbeth Leemans +32-16-344634/5 Liesbeth.leemans@uzleuven.be
Contact: Kristel Van Calsteren, MD PhD +32-16-346192 kristel.vancalsteren@uzleuven.be
Belgium
 
 
NCT00330447
cancer in pregnancy
No
Not Provided
Not Provided
Frederic Amant, University Hospital, Gasthuisberg
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
University Hospital, Gasthuisberg
November 2016