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Effects of Oncological Treatment During Pregnancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by University Hospital, Gasthuisberg
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
ClinicalTrials.gov Identifier:
NCT00330447
First received: May 25, 2006
Last updated: December 2, 2015
Last verified: December 2015
  Purpose
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
Cancer
Pregnancy

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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:

Primary Outcome Measures:
  • Follow-up of the mothers diagnosed with cancer during pregnancy [ Time Frame: anticipated ] [ Designated as safety issue: Yes ]
    Overall survival

  • Follow-up of the children antenatally exposed to chemotherapy or radiotherapy [ Time Frame: anticipated ] [ Designated as safety issue: Yes ]
    neurologic and cardiologic outcome


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

Estimated Enrollment: 5000
Study Start Date: August 2005
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Studygroup
Cancer in Pregnancy - all diagnoses and treatments Children born from mothers diagnosed with cancer during pregnancy
Control group
Children from the general population

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
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 
Study First Received: May 25, 2006
Last Updated: December 2, 2015
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 September 23, 2016