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NCT00330447RecruitingAccepts Healthy Volunteers

Effects of Oncological Treatment During Pregnancy on Mother and Child

University Hospital, Gasthuisberg

Start Date

8/1/2005

Completion Date

12/1/2032

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 Criteria

Age Range: 18 years to No maximum

Patients do not need to participate in both; however, preferentially both study parts should be performed. \*\*\*\*\*\*\*\*\*\*\*\*\*\*Part I: Pregnancy, delivery and maternal health\*\*\*\*\*\*\*\*\*\*\*\*\*\* Patients must meet the following inclusion criteria: * Histologically proven cancer in association with a pregnancy (during pregnancy or cancer dagnosis within 5 years after pregnancy) * \> 18 years of age, premenopausal * 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 or radiation therapy during pregnancy are allowed for the assessment of the maternal and fetal outcome (Part II). Exclusion Criteria: * Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent \*\*\*\*\*\*\*\*\*\*\*\*\*\*Part II: Follow-up of children\*\*\*\*\*\*\*\*\*\*\*\*\*\* Inclusion Criteria: \- 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. Exclusion Criteria: * Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent

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Conditions

CancerPregnancy

Locations

Cooper University Hospital (2015-ongoing)

Camden, New Jersey 08103

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, 3000

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 im Breisgau,

Germany

Euroclinic Hospital (2016-ongoing)

Athens,

Greece

Hellenic Anticancer-Oncological Hospital of Athens (retrospective 2015-2018)

Athens,

Greece

Ioannina University Hospital (retrosepctive 2015-2018)

Ioannina,

Greece

Hippokration Hospital (retrospective 2015-2018)

Thessaloniki,

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, 56530

Mexico

Erasmus Medical Center (2014-ongoing)

Rotterdam,

Netherlands

Haukeland University Hospital (2017-ongoing)

Bergen,

Norway

Medyczne Macierzynstwo (retrospective 2010-2018)

Krakow,

Poland

University Hospital Krakow (2018-ongoing)

Krakow,

Poland

Pozanan University of Medical Sciences (2017-ongoing)

Poznan,

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,

Russia

Research Center for Obstetrics, Gynecology and Perinatology (2014-ongoing)

Moscow,

Russia

Almazov National Medical Research Center (2018-ongoing)

Saint Petersburg,

Russia

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 (Türkiye)

Grigoriev Institute for medical Radiology (retrospective until 2018)

Kharkiv,

Ukraine