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Clinical Trials in Germany / NCT00330447
Recruiting Observational

Effects of Oncological Treatment During Pregnancy on Mother and Child

NCT00330447 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2005-08
Last updated
2024-03-06

Condition(s) studied

CancerPregnancy

Study 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).

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (33)

FacilityCityRegionStatus
Cooper University Hospital (2015-ongoing) Camden New Jersey Recruiting
Instituto Alexander Fleming Buenos Aires Argentina Withdrawn
Universitätsklinik für Frauenheilkunde und Geburtshilfe (retrospective 2016-2018) Graz Austria Terminated
UCL Brussels (2013-ongoing) Brussels Belgium Recruiting
UZ Gasthuisberg, Katholieke Universiteit Leuven (2004-ongoing) Leuven Belgium Recruiting
University Hospital Ostrava (2018-ongoing) Ostrava Czechia Recruiting
3rd medical faculty of Charles University (2010-ongoing) Prague Czechia Recruiting
Copenhagen University Hospital (2015-ongoing) Copenhagen Denmark Recruiting
Hopital Bichat-Claude-Bernard (retrospective until 2018) Paris France Terminated
Universitätsklinik Freiburg (retrospective until 2018) Freiburg im Breisgau Germany Terminated
Euroclinic Hospital (2016-ongoing) Athens Greece Recruiting
Hellenic Anticancer-Oncological Hospital of Athens (retrospective 2015-2018) Athens Greece Terminated
Ioannina University Hospital (retrosepctive 2015-2018) Ioannina Greece Terminated
Hippokration Hospital (retrospective 2015-2018) Thessaloniki Greece Terminated
European Institute of Oncology (2010-ongoing) Milan Italy Recruiting
Fondazione IRCCS Ca'Granda Ospedale Maggiore (2012-ongoing) Milan Italy Recruiting
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Milano (2017-ongoing) Milan Italy Recruiting
San Raffaele Hospital (2017-ongoing) Milan Italy Recruiting
CIttà della Salute e della Scienza di Torino (2015-ongoing) Torino Italy Recruiting
Regional Hospital of High Specialty of Ixtapaluca (2018-ongoing) Ixtapaluca Mexico Recruiting
Erasmus Medical Center (2014-ongoing) Rotterdam Netherlands Recruiting
Haukeland University Hospital (2017-ongoing) Bergen Norway Recruiting
Medyczne Macierzynstwo (retrospective 2010-2018) Krakow Poland Terminated
University Hospital Krakow (2018-ongoing) Krakow Poland Recruiting
Pozanan University of Medical Sciences (2017-ongoing) Poznan Poland Recruiting
Hospital de Vila Franca de Xira (2017-ongoing) Vila Franca de Xira Portugal Recruiting
N.N.Blokchin National Medical Research Center of Oncology (2013-2018 retrospective; 2018-ongoing prospective) Moscow Russia Recruiting
Research Center for Obstetrics, Gynecology and Perinatology (2014-ongoing) Moscow Russia Recruiting
Almazov National Medical Research Center (2018-ongoing) Saint Petersburg Russia Recruiting
Karolinska University Hospital (2017-ongoing) Stockholm Sweden Recruiting
F.Hached University Teaching Hospital (retrospective 2016-2018) Sousse Tunisia Terminated
Trakya University Faculty of Medicine (retrospective 2015-2018) Edirne Turkey (Türkiye) Terminated
Grigoriev Institute for medical Radiology (retrospective until 2018) Kharkiv Ukraine Terminated

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT00330447 on ClinicalTrials.gov ↗ ← All trials in Germany