JOURNAL ONKOLOGIE – STUDIE
Effects of Oncological Treatment During Pregnancy on Mother and Child
Rekrutierend
NCT-Nummer:
NCT00330447
Studienbeginn:
August 2005
Letztes Update:
18.11.2020
Wirkstoff:
-
Geschlecht:
Frauen
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
University Hospital, Gasthuisberg
Collaborator:
The Netherlands Cancer Institute, Erasmus Medical Center, San Gerardo Hospital, Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Milano, Charles University, Czech Republic,
Studienleiter
Principal Investigator
KULeuven, Belgium
Kontakt
Kontakt:
Phone: +32-16-342876
E-Mail: katrien.vantornout@uzleuven.be» Kontaktdaten anzeigen
Kontakt:
Phone: +32-16-346192
E-Mail: kristel.vancalsteren@uzleuven.be» Kontaktdaten anzeigen
Studienlocations (3 von 33)
Universitätsklinik Freiburg (retrospective until 2018)
Freiburg
(Baden-Württemberg)
GermanyAbgebrochen» Google-MapsCooper University Hospital (2015-ongoing)
08103 Camden
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Elyce Cardonick, MD» Ansprechpartner anzeigenInstituto Alexander Fleming
Buenos Aires
ArgentinaZurückgezogen» Google-Maps
Freiburg
(Baden-Württemberg)
GermanyAbgebrochen» Google-MapsCooper University Hospital (2015-ongoing)
08103 Camden
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Elyce Cardonick, MD» Ansprechpartner anzeigenInstituto Alexander Fleming
Buenos Aires
ArgentinaZurückgezogen» Google-Maps
Universitätsklinik für Frauenheilkunde und Geburtshilfe (retrospective 2016-2018)
Graz
AustriaAbgebrochen» Google-MapsUCL Brussels (2013-ongoing)
Brussels
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Mina Mhallem
E-Mail: katrien.vantornout@uzleuven.be» Ansprechpartner anzeigenUZ Gasthuisberg, Katholieke Universiteit Leuven (2004-ongoing)
3000 Leuven
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Frederic Amant, MD, PhD
Phone: +32-16-344252
E-Mail: frederic.amant@uzleuven.be
Kristel Van Calsteren, MD, PhD
Phone: +32-16-346192
E-Mail: kristel.vancalsteren@uzleuven.be» Ansprechpartner anzeigenUniversity Hospital Ostrava (2018-ongoing)
Ostrava
CzechiaRekrutierend» Google-Maps
Ansprechpartner:
Jaroslav Klát, MD» Ansprechpartner anzeigen3rd medical faculty of Charles University (2010-ongoing)
Prague
CzechiaRekrutierend» Google-Maps
Ansprechpartner:
Michael Halaska, MD» Ansprechpartner anzeigenCopenhagen University Hospital (2015-ongoing)
Copenhagen
DenmarkRekrutierend» Google-Maps
Ansprechpartner:
Lone Storgaard, MD» Ansprechpartner anzeigenHopital Bichat-Claude-Bernard (retrospective until 2018)
Paris
FranceAbgebrochen» Google-MapsEuroclinic Hospital (2016-ongoing)
Athens
GreeceRekrutierend» Google-Maps
Ansprechpartner:
Georeg-Marios Makris, MD» Ansprechpartner anzeigenHellenic Anticancer-Oncological Hospital of Athens (retrospective 2015-2018)
Athens
GreeceAbgebrochen» Google-MapsIoannina University Hospital (retrosepctive 2015-2018)
Ioánnina
GreeceAbgebrochen» Google-MapsHippokration Hospital (retrospective 2015-2018)
Thessaloníki
GreeceAbgebrochen» Google-MapsEuropean Institute of Oncology (2010-ongoing)
Milan
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Fedro Peccatori, MD» Ansprechpartner anzeigenFondazione IRCCS Ca'Granda Ospedale Maggiore (2012-ongoing)
Milan
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Monica Fumagalli, MD» Ansprechpartner anzeigenFondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Milano (2017-ongoing)
Milan
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Giovanna Scarfone, MD» Ansprechpartner anzeigenSan Raffaele Hospital (2017-ongoing)
Milan
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Giorgia Mangili, MD» Ansprechpartner anzeigenCIttà della Salute e della Scienza di Torino (2015-ongoing)
Torino
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Bianca Masturzo, MD» Ansprechpartner anzeigenRegional Hospital of High Specialty of Ixtapaluca (2018-ongoing)
56530 Ixtapaluca
MexicoRekrutierend» Google-Maps
Ansprechpartner:
Álvaro Cabrera Garciá, MD» Ansprechpartner anzeigenErasmus Medical Center (2014-ongoing)
Rotterdam
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
Ingrid Boere, MD PHD
E-Mail: cip@nki.nl» Ansprechpartner anzeigenHaukeland University Hospital (2017-ongoing)
Bergen
NorwayRekrutierend» Google-Maps
Ansprechpartner:
Line Bjorge» Ansprechpartner anzeigenMedyczne Macierzynstwo (retrospective 2010-2018)
Kraków
PolandAbgebrochen» Google-MapsUniversity Hospital Krakow (2018-ongoing)
Kraków
PolandRekrutierend» Google-Maps
Ansprechpartner:
Kolawa Wojciech» Ansprechpartner anzeigenPozanan University of Medical Sciences (2017-ongoing)
Poznań
PolandRekrutierend» Google-Maps
Ansprechpartner:
Stefan Sajdak, MD» Ansprechpartner anzeigenHospital de Vila Franca de Xira (2017-ongoing)
Vila Franca De Xira
PortugalRekrutierend» Google-Maps
Ansprechpartner:
Paula Duarte, MD» Ansprechpartner anzeigenN.N.Blokchin National Medical Research Center of Oncology (2013-2018 retrospective; 2018-ongoing prospective)
Moscow
Russian FederationRekrutierend» Google-Maps
Ansprechpartner:
Anastasia Parokonnaya, MD» Ansprechpartner anzeigenResearch Center for Obstetrics, Gynecology and Perinatology (2014-ongoing)
Moscow
Russian FederationRekrutierend» Google-Maps
Ansprechpartner:
Roman Shmakov, MD» Ansprechpartner anzeigenAlmazov National Medical Research Center (2018-ongoing)
Saint Petersburg
Russian FederationRekrutierend» Google-Maps
Ansprechpartner:
Vladim Bezrukikh» Ansprechpartner anzeigenKarolinska University Hospital (2017-ongoing)
Stockholm
SwedenRekrutierend» Google-Maps
Ansprechpartner:
Kenny Rodriguez-Wallberg, MD» Ansprechpartner anzeigenF.Hached University Teaching Hospital (retrospective 2016-2018)
Sousse
TunisiaAbgebrochen» Google-MapsTrakya University Faculty of Medicine (retrospective 2015-2018)
Edirne
TurkeyAbgebrochen» Google-MapsGrigoriev Institute for medical Radiology (retrospective until 2018)
Kharkov
UkraineAbgebrochen» Google-Maps
Alle anzeigen Graz
AustriaAbgebrochen» Google-MapsUCL Brussels (2013-ongoing)
Brussels
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Mina Mhallem
E-Mail: katrien.vantornout@uzleuven.be» Ansprechpartner anzeigenUZ Gasthuisberg, Katholieke Universiteit Leuven (2004-ongoing)
3000 Leuven
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Frederic Amant, MD, PhD
Phone: +32-16-344252
E-Mail: frederic.amant@uzleuven.be
Kristel Van Calsteren, MD, PhD
Phone: +32-16-346192
E-Mail: kristel.vancalsteren@uzleuven.be» Ansprechpartner anzeigenUniversity Hospital Ostrava (2018-ongoing)
Ostrava
CzechiaRekrutierend» Google-Maps
Ansprechpartner:
Jaroslav Klát, MD» Ansprechpartner anzeigen3rd medical faculty of Charles University (2010-ongoing)
Prague
CzechiaRekrutierend» Google-Maps
Ansprechpartner:
Michael Halaska, MD» Ansprechpartner anzeigenCopenhagen University Hospital (2015-ongoing)
Copenhagen
DenmarkRekrutierend» Google-Maps
Ansprechpartner:
Lone Storgaard, MD» Ansprechpartner anzeigenHopital Bichat-Claude-Bernard (retrospective until 2018)
Paris
FranceAbgebrochen» Google-MapsEuroclinic Hospital (2016-ongoing)
Athens
GreeceRekrutierend» Google-Maps
Ansprechpartner:
Georeg-Marios Makris, MD» Ansprechpartner anzeigenHellenic Anticancer-Oncological Hospital of Athens (retrospective 2015-2018)
Athens
GreeceAbgebrochen» Google-MapsIoannina University Hospital (retrosepctive 2015-2018)
Ioánnina
GreeceAbgebrochen» Google-MapsHippokration Hospital (retrospective 2015-2018)
Thessaloníki
GreeceAbgebrochen» Google-MapsEuropean Institute of Oncology (2010-ongoing)
Milan
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Fedro Peccatori, MD» Ansprechpartner anzeigenFondazione IRCCS Ca'Granda Ospedale Maggiore (2012-ongoing)
Milan
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Monica Fumagalli, MD» Ansprechpartner anzeigenFondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Milano (2017-ongoing)
Milan
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Giovanna Scarfone, MD» Ansprechpartner anzeigenSan Raffaele Hospital (2017-ongoing)
Milan
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Giorgia Mangili, MD» Ansprechpartner anzeigenCIttà della Salute e della Scienza di Torino (2015-ongoing)
Torino
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Bianca Masturzo, MD» Ansprechpartner anzeigenRegional Hospital of High Specialty of Ixtapaluca (2018-ongoing)
56530 Ixtapaluca
MexicoRekrutierend» Google-Maps
Ansprechpartner:
Álvaro Cabrera Garciá, MD» Ansprechpartner anzeigenErasmus Medical Center (2014-ongoing)
Rotterdam
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
Ingrid Boere, MD PHD
E-Mail: cip@nki.nl» Ansprechpartner anzeigenHaukeland University Hospital (2017-ongoing)
Bergen
NorwayRekrutierend» Google-Maps
Ansprechpartner:
Line Bjorge» Ansprechpartner anzeigenMedyczne Macierzynstwo (retrospective 2010-2018)
Kraków
PolandAbgebrochen» Google-MapsUniversity Hospital Krakow (2018-ongoing)
Kraków
PolandRekrutierend» Google-Maps
Ansprechpartner:
Kolawa Wojciech» Ansprechpartner anzeigenPozanan University of Medical Sciences (2017-ongoing)
Poznań
PolandRekrutierend» Google-Maps
Ansprechpartner:
Stefan Sajdak, MD» Ansprechpartner anzeigenHospital de Vila Franca de Xira (2017-ongoing)
Vila Franca De Xira
PortugalRekrutierend» Google-Maps
Ansprechpartner:
Paula Duarte, MD» Ansprechpartner anzeigenN.N.Blokchin National Medical Research Center of Oncology (2013-2018 retrospective; 2018-ongoing prospective)
Moscow
Russian FederationRekrutierend» Google-Maps
Ansprechpartner:
Anastasia Parokonnaya, MD» Ansprechpartner anzeigenResearch Center for Obstetrics, Gynecology and Perinatology (2014-ongoing)
Moscow
Russian FederationRekrutierend» Google-Maps
Ansprechpartner:
Roman Shmakov, MD» Ansprechpartner anzeigenAlmazov National Medical Research Center (2018-ongoing)
Saint Petersburg
Russian FederationRekrutierend» Google-Maps
Ansprechpartner:
Vladim Bezrukikh» Ansprechpartner anzeigenKarolinska University Hospital (2017-ongoing)
Stockholm
SwedenRekrutierend» Google-Maps
Ansprechpartner:
Kenny Rodriguez-Wallberg, MD» Ansprechpartner anzeigenF.Hached University Teaching Hospital (retrospective 2016-2018)
Sousse
TunisiaAbgebrochen» Google-MapsTrakya University Faculty of Medicine (retrospective 2015-2018)
Edirne
TurkeyAbgebrochen» Google-MapsGrigoriev Institute for medical Radiology (retrospective until 2018)
Kharkov
UkraineAbgebrochen» Google-Maps
Studien-Informationen
Detailed Description: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.
Ein-/Ausschlusskriterien
Patients do not need to participate in both; however, preferentially both study partsshould 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.
Exclusion Criteria:
- Mentally disabled or significantly altered mental status that would prohibit the
understanding and giving of informed consent
Studien-Rationale
Primary outcome:1. Follow-up of the mothers diagnosed with cancer during pregnancy (Time Frame - anticipated):
treatment during pregnancy, obstetrical outcome, maternal survival
2. Follow-up of the children antenatally exposed to chemotherapy or radiotherapy (Time Frame - anticipated):
neurologic and cardiologic outcome
Studien-Arme
- Studygroup
Cancer in Pregnancy - all diagnoses and treatments Children born from mothers diagnosed with cancer during pregnancy - Control group
Children from the general population
Quelle: ClinicalTrials.gov