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JOURNAL ONKOLOGIE – STUDIE

Effects of Oncological Treatment During Pregnancy on Mother and Child

Rekrutierend

NCT-Nummer:
NCT00330447

Studienbeginn:
August 2005

Letztes Update:
06.03.2024

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, Charles University, Czech Republic,

Studienleiter

Amant Frederic, MD PhD
Principal Investigator
KULeuven, Belgium

Kontakt

Studienlocations
(3 von 33)

Universitätsklinik Freiburg (retrospective until 2018)
Freiburg
(Baden-Württemberg)
GermanyAbgebrochen» Google-Maps
Instituto Alexander Fleming
Buenos Aires
ArgentinaZurückgezogen» Google-Maps
Universitätsklinik für Frauenheilkunde und Geburtshilfe (retrospective 2016-2018)
Graz
AustriaAbgebrochen» Google-Maps
UZ 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 anzeigen
Hopital Bichat-Claude-Bernard (retrospective until 2018)
Paris
FranceAbgebrochen» Google-Maps
Hellenic Anticancer-Oncological Hospital of Athens (retrospective 2015-2018)
Athens
GreeceAbgebrochen» Google-Maps
Ioannina University Hospital (retrosepctive 2015-2018)
Ioánnina
GreeceAbgebrochen» Google-Maps
Hippokration Hospital (retrospective 2015-2018)
Thessaloníki
GreeceAbgebrochen» Google-Maps
Medyczne Macierzynstwo (retrospective 2010-2018)
Kraków
PolandAbgebrochen» Google-Maps
N.N.Blokchin National Medical Research Center of Oncology (2013-2018 retrospective; 2018-ongoing prospective)
Moscow
Russian FederationRekrutierend» Google-Maps
Ansprechpartner:
Anastasia Parokonnaya, MD» Ansprechpartner anzeigen
F.Hached University Teaching Hospital (retrospective 2016-2018)
Sousse
TunisiaAbgebrochen» Google-Maps
Trakya University Faculty of Medicine (retrospective 2015-2018)
Edirne
TurkeyAbgebrochen» Google-Maps
Grigoriev Institute for medical Radiology (retrospective until 2018)
Kharkov
UkraineAbgebrochen» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

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


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