Effects of Oncological Treatment During Pregnancy on Mother and Child
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|ClinicalTrials.gov Identifier: NCT00330447|
Recruitment Status : Recruiting
First Posted : May 26, 2006
Last Update Posted : May 22, 2018
|Condition or disease|
Study contains several study parts (protocol version 4.2):
**********Part I. Pregnancy, delivery and maternal health********** Part I.I.A. Registration study 'Cancer during pregnancy' mother and neonate None Part I.I.B. Effects of prenatal exposure to cancer treatment on fetal growth. The association between placental pathophysiologic mechanisms (histopathology and immunohistochemistry), circulating maternal factors and fetal growth.
From participating women, a maternal blood sample will be collected during or shortly after birth. Also, an umbilical cord blood sample and placental and umbilical cord biopsies will be drawn.
Part I.II. Measurement of maternal and paternal anxiety and emotional needs when confronted with a cancer diagnosis during pregnancy The participants will be asked to complete questionnaires. Part I.III. Biobank 'cancer and pregnancy' From participating women, a tumour biopsy specimen before administration of neoadjuvant therapy will be collected at the time of diagnosis. Also, maternal blood samples will be collected before and/or after treatment.
Part I.IV. Study on the pharmacokinetics of chemotherapeutic agents in pregnant women Approximately 10-12 additional peripheral venous blood withdrawals.
**********Part II. Child********** Long term follow up of children and adolescents in utero exposed to chemotherapy and/or radiotherapy Regular check-ups of the child, at the age of 18months, 3y, 6y, 9y, 12y, 15y, and 18y, and after the age of 18 years: 5-yearly cardiologic assessment and questionnaires (23y, 28y, 33y, 38y, and 43y). Optional at the ages of 9y, 12y, 15y and 18y: MRI session.
Summary part I:
Prospectively the outcome of mothers diagnosed and/or treated for cancer during pregnancy will be registered and investigated.
Summary Part II:
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|
|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 :||December 2032|
Cancer in Pregnancy - all diagnoses and treatments Children born from mothers diagnosed with cancer during pregnancy
Children from the general population
- Follow-up of the mothers diagnosed with cancer during pregnancy [ Time Frame: anticipated ]treatment during pregnancy, obstetrical outcome, maternal survival
- Follow-up of the children antenatally exposed to chemotherapy or radiotherapy [ Time Frame: anticipated ]neurologic and cardiologic outcome
Biospecimen Retention: Samples With DNA
Maternal blood serum and sediment of blood; from 2010 on we collect umbilical cord blood.
Since new approval of protocol version 4.2 (08-02-2018) we collect samples of placental tissue, umbilical cord tissue and membranes.
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
|Contact: Katrien Van Tornoutemail@example.com|
|Contact: Kristel Van Calsteren, MD PhDfirstname.lastname@example.org|
|Contact: Mina Mhallem email@example.com|
|UZ Gasthuisberg, Katholieke Universiteit Leuven||Recruiting|
|Leuven, Belgium, 3000|
|Contact: Frederic Amant, MD, PhD +32-16-344252 firstname.lastname@example.org|
|Contact: Kristel Van Calsteren, MD, PhD +32-16-346192 email@example.com|
|Sub-Investigator: Lieven Lagae, MD, PhD|
|Sub-Investigator: Luc Mertens, MD, PhD|
|Principal Investigator: Frederic Amant, MD, PhD|
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|Sub-Investigator: Laurence Claes, PhD|
|Sub-Investigator: Monica Fumagalli, MD PhD|
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|Contact: Ingrid Boere, MD PHD firstname.lastname@example.org|
|Principal Investigator: Frédéric Amant, MD PHD|
|Sub-Investigator: C.A.R. Lok, MD PHD|
|Sub-Investigator: M.M. Van den Heuvel-Eibrink, MD PHD|
|Sub-Investigator: C.J.M. De Groot, MD PHD|
|Sub-Investigator: R.C. Painter, MD PHD|
|Sub-Investigator: P.B. Ottevanger, MD PHD|
|Sub-Investigator: P.O. Witteveen, MD PHD|
|Sub-Investigator: C.P. Schröder, MD PHD|
|Sub-Investigator: S.J. Gordijn, MD PHD|
|Sub-Investigator: J. Kroep, MD PHD|
|Sub-Investigator: R.L.M. Bekkers, MD PHD|
|Sub-Investigator: A.M.J. Thijs, MD PHD|
|Research Center for Obstetrics, Gynecology and Perinatology||Recruiting|
|Moscow, Russian Federation|
|Contact: Roman Shmakov, MD|
|Principal Investigator:||Amant Frederic, MD PhD||KULeuven, Belgium|