Spots Global Cancer Trial Database for Effects of Oncological Treatment During Pregnancy on Mother and Child
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Trial Identification
Brief Title: Effects of Oncological Treatment During Pregnancy on Mother and Child
Official Title: Oncological Treatment During Pregnancy: Pharmacokinetics of Chemotherapy and Long Term Follow up of the Offspring
Study ID: NCT00330447
Interventions
Study Description
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 cancer or cancer treatment (cytotoxic drugs, radiation therapy, targeted therapy,...) develop normally (neurologic and cardiologic examination).
Detailed Description: Study contains several study parts (protocol version 4.4): \*\*\*\*\*\*\*\*\*\*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 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 6 months, 18 months, 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
Cooper University Hospital (2015-ongoing), Camden, New Jersey, United States
Instituto Alexander Fleming, Buenos Aires, , Argentina
Universitätsklinik für Frauenheilkunde und Geburtshilfe (retrospective 2016-2018), Graz, , Austria
UCL Brussels (2013-ongoing), Brussels, , Belgium
UZ Gasthuisberg, Katholieke Universiteit Leuven (2004-ongoing), Leuven, , Belgium
University Hospital Ostrava (2018-ongoing), Ostrava, , Czechia
3rd medical faculty of Charles University (2010-ongoing), Prague, , Czechia
Copenhagen University Hospital (2015-ongoing), Copenhagen, , Denmark
Hopital Bichat-Claude-Bernard (retrospective until 2018), Paris, , France
Universitätsklinik Freiburg (retrospective until 2018), Freiburg, , Germany
Euroclinic Hospital (2016-ongoing), Athens, , Greece
Hellenic Anticancer-Oncological Hospital of Athens (retrospective 2015-2018), Athens, , Greece
Ioannina University Hospital (retrosepctive 2015-2018), Ioánnina, , Greece
Hippokration Hospital (retrospective 2015-2018), Thessaloníki, , Greece
European Institute of Oncology (2010-ongoing), Milan, , Italy
Fondazione IRCCS Ca'Granda Ospedale Maggiore (2012-ongoing), Milan, , Italy
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Milano (2017-ongoing), Milan, , Italy
San Raffaele Hospital (2017-ongoing), Milan, , Italy
CIttà della Salute e della Scienza di Torino (2015-ongoing), Torino, , Italy
Regional Hospital of High Specialty of Ixtapaluca (2018-ongoing), Ixtapaluca, , Mexico
Erasmus Medical Center (2014-ongoing), Rotterdam, , Netherlands
Haukeland University Hospital (2017-ongoing), Bergen, , Norway
Medyczne Macierzynstwo (retrospective 2010-2018), Kraków, , Poland
University Hospital Krakow (2018-ongoing), Kraków, , Poland
Pozanan University of Medical Sciences (2017-ongoing), Poznań, , Poland
Hospital de Vila Franca de Xira (2017-ongoing), Vila Franca De Xira, , Portugal
N.N.Blokchin National Medical Research Center of Oncology (2013-2018 retrospective; 2018-ongoing prospective), Moscow, , Russian Federation
Research Center for Obstetrics, Gynecology and Perinatology (2014-ongoing), Moscow, , Russian Federation
Almazov National Medical Research Center (2018-ongoing), Saint Petersburg, , Russian Federation
Karolinska University Hospital (2017-ongoing), Stockholm, , Sweden
F.Hached University Teaching Hospital (retrospective 2016-2018), Sousse, , Tunisia
Trakya University Faculty of Medicine (retrospective 2015-2018), Edirne, , Turkey
Grigoriev Institute for medical Radiology (retrospective until 2018), Kharkov, , Ukraine
Contact Details
Name: Amant Frederic, MD PhD
Affiliation: KULeuven, Belgium
Role: PRINCIPAL_INVESTIGATOR
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