Effects of Oncological Treatment During Pregnancy on Mother and Child

Last updated: March 4, 2024
Sponsor: University Hospital, Gasthuisberg
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy

Cancer

Treatment

N/A

Clinical Study ID

NCT00330447
cancer in pregnancy
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

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 orcancer dagnosis within 5 years after pregnancy)
  • > 18 years of age, premenopausal
  • Patients who have given their signed and written informed consent to participate inthe trial after fully understanding the implication of the protocol
  • Women receiving any cytotoxic drug or radiation therapy during pregnancy are allowedfor the assessment of the maternal and fetal outcome (Part II).

Exclusion

Exclusion Criteria:

  • Mentally disabled or significantly altered mental status that would prohibit theunderstanding 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 isasked from parents. From the age of 12 years, informed assent is additionally asked fromthe 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 theunderstanding and giving of informed consent

Study Design

Total Participants: 5000
Study Start date:
August 01, 2005
Estimated Completion Date:
December 31, 2032

Study 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.

Connect with a study center

  • Instituto Alexander Fleming

    Buenos Aires,
    Argentina

    Site Not Available

  • Universitätsklinik für Frauenheilkunde und Geburtshilfe (retrospective 2016-2018)

    Graz,
    Austria

    Terminated

  • UCL Brussels (2013-ongoing)

    Brussels,
    Belgium

    Active - Recruiting

  • UZ Gasthuisberg, Katholieke Universiteit Leuven (2004-ongoing)

    Leuven, 3000
    Belgium

    Active - Recruiting

  • University Hospital Ostrava (2018-ongoing)

    Ostrava,
    Czechia

    Active - Recruiting

  • 3rd medical faculty of Charles University (2010-ongoing)

    Prague,
    Czechia

    Active - Recruiting

  • Copenhagen University Hospital (2015-ongoing)

    Copenhagen,
    Denmark

    Active - Recruiting

  • Hopital Bichat-Claude-Bernard (retrospective until 2018)

    Paris,
    France

    Terminated

  • Universitätsklinik Freiburg (retrospective until 2018)

    Freiburg,
    Germany

    Terminated

  • Euroclinic Hospital (2016-ongoing)

    Athens,
    Greece

    Active - Recruiting

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

    Athens,
    Greece

    Terminated

  • Ioannina University Hospital (retrosepctive 2015-2018)

    Ioánnina,
    Greece

    Terminated

  • Hippokration Hospital (retrospective 2015-2018)

    Thessaloníki,
    Greece

    Terminated

  • European Institute of Oncology (2010-ongoing)

    Milan,
    Italy

    Active - Recruiting

  • Fondazione IRCCS Ca'Granda Ospedale Maggiore (2012-ongoing)

    Milan,
    Italy

    Active - Recruiting

  • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Milano (2017-ongoing)

    Milan,
    Italy

    Active - Recruiting

  • San Raffaele Hospital (2017-ongoing)

    Milan,
    Italy

    Active - Recruiting

  • CIttà della Salute e della Scienza di Torino (2015-ongoing)

    Torino,
    Italy

    Active - Recruiting

  • Regional Hospital of High Specialty of Ixtapaluca (2018-ongoing)

    Ixtapaluca, 56530
    Mexico

    Active - Recruiting

  • Erasmus Medical Center (2014-ongoing)

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Haukeland University Hospital (2017-ongoing)

    Bergen,
    Norway

    Active - Recruiting

  • Medyczne Macierzynstwo (retrospective 2010-2018)

    Kraków,
    Poland

    Terminated

  • University Hospital Krakow (2018-ongoing)

    Kraków,
    Poland

    Active - Recruiting

  • Pozanan University of Medical Sciences (2017-ongoing)

    Poznań,
    Poland

    Active - Recruiting

  • Hospital de Vila Franca de Xira (2017-ongoing)

    Vila Franca De Xira,
    Portugal

    Active - Recruiting

  • N.N.Blokchin National Medical Research Center of Oncology (2013-2018 retrospective; 2018-ongoing prospective)

    Moscow,
    Russian Federation

    Active - Recruiting

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

    Moscow,
    Russian Federation

    Active - Recruiting

  • Almazov National Medical Research Center (2018-ongoing)

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • Karolinska University Hospital (2017-ongoing)

    Stockholm,
    Sweden

    Active - Recruiting

  • F.Hached University Teaching Hospital (retrospective 2016-2018)

    Sousse,
    Tunisia

    Terminated

  • Trakya University Faculty of Medicine (retrospective 2015-2018)

    Edirne,
    Turkey

    Terminated

  • Grigoriev Institute for medical Radiology (retrospective until 2018)

    Kharkov,
    Ukraine

    Terminated

  • Cooper University Hospital (2015-ongoing)

    Camden, New Jersey 08103
    United States

    Active - Recruiting

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