Effects of Oncological Treatment During Pregnancy on Mother and Child

March 4, 2024 updated by: Frederic Amant, University Hospital, Gasthuisberg

Oncological Treatment During Pregnancy: Pharmacokinetics of Chemotherapy and Long Term Follow up of the Offspring

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).

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Withdrawn
        • Instituto Alexander Fleming
  • Austria
      • Graz, Austria
        • Terminated
        • Universitätsklinik für Frauenheilkunde und Geburtshilfe (retrospective 2016-2018)
  • Belgium
      • Brussels, Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Gasthuisberg, Katholieke Universiteit Leuven (2004-ongoing)
        • Principal Investigator:
          • Frédéric Amant, MD, PhD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Lieven Lagae, MD, PhD
        • Sub-Investigator:
          • Luc Mertens, MD, PhD
        • Sub-Investigator:
          • Kristel Van Calsteren, MD
        • Sub-Investigator:
          • Michael Halaska, MD
        • Sub-Investigator:
          • Monica Fumagalli, MD PhD
        • Sub-Investigator:
          • Maarten Lambrecht, MD PhD
  • Czechia
      • Ostrava, Czechia
        • Recruiting
        • University Hospital Ostrava (2018-ongoing)
        • Contact:
          • Jaroslav Klát, MD
      • Prague, Czechia
        • Recruiting
        • 3rd medical faculty of Charles University (2010-ongoing)
        • Contact:
          • Michael Halaska, MD
  • Denmark
      • Copenhagen, Denmark
        • Recruiting
        • Copenhagen University Hospital (2015-ongoing)
        • Contact:
          • Lone Storgaard, MD
        • Sub-Investigator:
          • Berit Woetmann Pedersen, MD
        • Sub-Investigator:
          • Mona Aarenstrup, MD
        • Sub-Investigator:
          • Cristel Maria Soerensen-Hjortshoej, MD
  • France
      • Paris, France
        • Terminated
        • Hopital Bichat-Claude-Bernard (retrospective until 2018)
  • Germany
      • Freiburg, Germany
        • Terminated
        • Universitätsklinik Freiburg (retrospective until 2018)
  • Greece
      • Athens, Greece
        • Recruiting
        • Euroclinic Hospital (2016-ongoing)
        • Contact:
          • Georeg-Marios Makris, MD
      • Athens, Greece
        • Terminated
        • Hellenic Anticancer-Oncological Hospital of Athens (retrospective 2015-2018)
      • Ioánnina, Greece
        • Terminated
        • Ioannina University Hospital (retrosepctive 2015-2018)
      • Thessaloníki, Greece
        • Terminated
        • Hippokration Hospital (retrospective 2015-2018)
  • Italy
      • Milan, Italy
        • Recruiting
        • European Institute of Oncology (2010-ongoing)
        • Contact:
          • Fedro Peccatori, MD
      • Milan, Italy
        • Recruiting
        • Fondazione IRCCS Ca'Granda Ospedale Maggiore (2012-ongoing)
        • Contact:
          • Monica Fumagalli, MD
      • Milan, Italy
        • Recruiting
        • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Milano (2017-ongoing)
        • Contact:
          • Giovanna Scarfone, MD
      • Milan, Italy
        • Recruiting
        • San Raffaele Hospital (2017-ongoing)
        • Contact:
          • Giorgia Mangili, MD
      • Torino, Italy
        • Recruiting
        • CIttà della Salute e della Scienza di Torino (2015-ongoing)
        • Contact:
          • Bianca Masturzo, MD
  • Mexico
      • Ixtapaluca, Mexico, 56530
        • Recruiting
        • Regional Hospital of High Specialty of Ixtapaluca (2018-ongoing)
        • Contact:
          • Álvaro Cabrera Garciá, MD
  • Netherlands
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus Medical Center (2014-ongoing)
        • Contact:
        • Principal Investigator:
          • Frédéric Amant, MD PHD
        • Sub-Investigator:
          • C.A.R. Lok, MD PHD
        • Sub-Investigator:
          • M.M. Van den Heuvel-Eibrink, MD PHD
        • Sub-Investigator:
          • C.J.M. De Groot, MD PHD
        • Sub-Investigator:
          • R.C. Painter, MD PHD
        • Sub-Investigator:
          • P.B. Ottevanger, MD PHD
        • Sub-Investigator:
          • P.O. Witteveen, MD PHD
        • Sub-Investigator:
          • C.P. Schröder, MD PHD
        • Sub-Investigator:
          • S.J. Gordijn, MD PHD
        • Sub-Investigator:
          • J. Kroep, MD PHD
        • Sub-Investigator:
          • R.L.M. Bekkers, MD PHD
        • Sub-Investigator:
          • A.M.J. Thijs, MD PHD
  • Norway
      • Bergen, Norway
        • Recruiting
        • Haukeland University Hospital (2017-ongoing)
        • Contact:
          • Line Bjorge
  • Poland
      • Kraków, Poland
        • Terminated
        • Medyczne Macierzynstwo (retrospective 2010-2018)
      • Kraków, Poland
        • Recruiting
        • University Hospital Krakow (2018-ongoing)
        • Contact:
          • Kolawa Wojciech
        • Sub-Investigator:
          • Marta Balajewicz-Nowak, MD
        • Sub-Investigator:
          • Kazimierz Pitynski, MD
      • Poznań, Poland
        • Recruiting
        • Pozanan University of Medical Sciences (2017-ongoing)
        • Contact:
          • Stefan Sajdak, MD
  • Portugal
      • Vila Franca De Xira, Portugal
        • Recruiting
        • Hospital de Vila Franca de Xira (2017-ongoing)
        • Contact:
          • Paula Duarte, MD
  • Russian Federation
      • Moscow, Russian Federation
        • Recruiting
        • N.N.Blokchin National Medical Research Center of Oncology (2013-2018 retrospective; 2018-ongoing prospective)
        • Contact:
          • Anastasia Parokonnaya, MD
      • Moscow, Russian Federation
        • Recruiting
        • Research Center for Obstetrics, Gynecology and Perinatology (2014-ongoing)
        • Contact:
          • Roman Shmakov, MD
      • Saint Petersburg, Russian Federation
        • Recruiting
        • Almazov National Medical Research Center (2018-ongoing)
        • Contact:
          • Vladim Bezrukikh
  • Sweden
      • Stockholm, Sweden
        • Recruiting
        • Karolinska University Hospital (2017-ongoing)
        • Contact:
          • Kenny Rodriguez-Wallberg, MD
  • Tunisia
      • Sousse, Tunisia
        • Terminated
        • F.Hached University Teaching Hospital (retrospective 2016-2018)
  • Turkey
      • Edirne, Turkey
        • Terminated
        • Trakya University Faculty of Medicine (retrospective 2015-2018)
  • Ukraine
      • Kharkov, Ukraine
        • Terminated
        • Grigoriev Institute for medical Radiology (retrospective until 2018)
  • United States
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • Cooper University Hospital (2015-ongoing)
        • Contact:
          • Elyce Cardonick, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Premenopausal women with a cancer diagnosis in association with cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Studygroup
Cancer in Pregnancy - all diagnoses and treatments Children born from mothers diagnosed with cancer during pregnancy
Control group
Children from the general population

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follow-up of the mothers diagnosed with cancer during pregnancy
Time Frame: anticipated
treatment during pregnancy, obstetrical outcome, maternal survival
anticipated
Follow-up of the children antenatally exposed to chemotherapy or radiotherapy
Time Frame: anticipated
neurologic and cardiologic outcome
anticipated

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gasthuisberg

Collaborators

Charles University, Czech Republic
Erasmus Medical Center
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
The Netherlands Cancer Institute
San Gerardo Hospital

Investigators

  • Principal Investigator: Amant Frederic, MD PhD, KULeuven, Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2005

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

December 1, 2032

Study Registration Dates

First Submitted

May 25, 2006

First Submitted That Met QC Criteria

May 25, 2006

First Posted (Estimated)

May 26, 2006

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • cancer in pregnancy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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