Effects of Oncological Treatment During Pregnancy on Mother and Child
- Conditions
- CancerPregnancy
- Registration Number
- NCT00330447
- Lead Sponsor
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 5000
- Children that were prenatally exposed to cancer of cancer treament. Informed Consent is asked from parents. From the age of 12 years, informed assent is additionally asked from the child. After the age of 18 years, informed consent is solely asked of the offspring.
- Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Follow-up of the children antenatally exposed to chemotherapy or radiotherapy anticipated neurologic and cardiologic outcome
Follow-up of the mothers diagnosed with cancer during pregnancy anticipated treatment during pregnancy, obstetrical outcome, maternal survival
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (33)
UCL Brussels (2013-ongoing)
🇧🇪Brussels, Belgium
Universitätsklinik Freiburg (retrospective until 2018)
🇩🇪Freiburg, Germany
N.N.Blokchin National Medical Research Center of Oncology (2013-2018 retrospective; 2018-ongoing prospective)
🇷🇺Moscow, Russian Federation
Instituto Alexander Fleming
🇦🇷Buenos Aires, Argentina
Hellenic Anticancer-Oncological Hospital of Athens (retrospective 2015-2018)
🇬🇷Athens, Greece
Ioannina University Hospital (retrosepctive 2015-2018)
🇬🇷Ioánnina, Greece
CIttà della Salute e della Scienza di Torino (2015-ongoing)
🇮🇹Torino, Italy
Regional Hospital of High Specialty of Ixtapaluca (2018-ongoing)
🇲🇽Ixtapaluca, Mexico
Haukeland University Hospital (2017-ongoing)
🇳🇴Bergen, Norway
University Hospital Krakow (2018-ongoing)
🇵🇱Kraków, Poland
Universitätsklinik für Frauenheilkunde und Geburtshilfe (retrospective 2016-2018)
🇦🇹Graz, Austria
Hippokration Hospital (retrospective 2015-2018)
🇬🇷Thessaloníki, Greece
European Institute of Oncology (2010-ongoing)
🇮🇹Milan, Italy
Erasmus Medical Center (2014-ongoing)
🇳🇱Rotterdam, Netherlands
Medyczne Macierzynstwo (retrospective 2010-2018)
🇵🇱Kraków, Poland
Pozanan University of Medical Sciences (2017-ongoing)
🇵🇱Poznań, Poland
Almazov National Medical Research Center (2018-ongoing)
🇷🇺Saint Petersburg, Russian Federation
F.Hached University Teaching Hospital (retrospective 2016-2018)
🇹🇳Sousse, Tunisia
3rd medical faculty of Charles University (2010-ongoing)
🇨🇿Prague, Czechia
Cooper University Hospital (2015-ongoing)
🇺🇸Camden, New Jersey, United States
UZ Gasthuisberg, Katholieke Universiteit Leuven (2004-ongoing)
🇧🇪Leuven, Belgium
University Hospital Ostrava (2018-ongoing)
🇨🇿Ostrava, Czechia
Euroclinic Hospital (2016-ongoing)
🇬🇷Athens, Greece
Fondazione IRCCS Ca'Granda Ospedale Maggiore (2012-ongoing)
🇮🇹Milan, Italy
Copenhagen University Hospital (2015-ongoing)
🇩🇰Copenhagen, Denmark
Hopital Bichat-Claude-Bernard (retrospective until 2018)
🇫🇷Paris, France
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Milano (2017-ongoing)
🇮🇹Milan, Italy
San Raffaele Hospital (2017-ongoing)
🇮🇹Milan, Italy
Karolinska University Hospital (2017-ongoing)
🇸🇪Stockholm, Sweden
Grigoriev Institute for medical Radiology (retrospective until 2018)
🇺🇦Kharkov, Ukraine
Hospital de Vila Franca de Xira (2017-ongoing)
🇵🇹Vila Franca De Xira, Portugal
Trakya University Faculty of Medicine (retrospective 2015-2018)
🇹🇷Edirne, Turkey
Research Center for Obstetrics, Gynecology and Perinatology (2014-ongoing)
🇷🇺Moscow, Russian Federation