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Effects of Oncological Treatment During Pregnancy on Mother and Child

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ClinicalTrials.gov Identifier: NCT00330447
Recruitment Status : Recruiting
First Posted : May 26, 2006
Last Update Posted : May 22, 2018
Sponsor:
Collaborators:
Laurence Claes, PhD
Ingrid Boere, MD PhD
Michael Halaska, MD PhD
Lagae, Lieven, M.D., Ph.D.
Mertens, Luc, M.D., Ph.D.
Monica Fumagalli, MD PhD
Kristel Van Calsteren, MD PhD
Christianne Lok, MD PhD
Robert Fruscio, MD PhD
Marry van den Heuvel-Eibrink, MD PhD
Information provided by (Responsible Party):
Frederic Amant, University Hospital, Gasthuisberg

Brief 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).

Condition or disease
Cancer Pregnancy

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 18 Years
Official Title: Oncological Treatment During Pregnancy: Pharmacokinetics of Chemotherapy and Long Term Follow up of the Offspring
Study Start Date : August 2005
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : December 2032

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



Primary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA

Maternal blood serum and sediment of blood; from 2010 on we collect umbilical cord blood.

Since new approval of protocol version 4.2 (08-02-2018) we collect samples of placental tissue, umbilical cord tissue and membranes.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Premenopausal women with a cancer diagnosis in association with cancer
Criteria

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.

Exclusion Criteria:

  • Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330447


Contacts
Contact: Katrien Van Tornout +32-16-342876 katrien.vantornout@uzleuven.be
Contact: Kristel Van Calsteren, MD PhD +32-16-346192 kristel.vancalsteren@uzleuven.be

Locations
Belgium
UCL Brussels Recruiting
Brussels, Belgium
Contact: Mina Mhallem       katrien.vantornout@uzleuven.be   
UZ Gasthuisberg, Katholieke Universiteit Leuven Recruiting
Leuven, Belgium, 3000
Contact: Frederic Amant, MD, PhD    +32-16-344252    frederic.amant@uzleuven.be   
Contact: Kristel Van Calsteren, MD, PhD    +32-16-346192    kristel.vancalsteren@uzleuven.be   
Sub-Investigator: Lieven Lagae, MD, PhD         
Sub-Investigator: Luc Mertens, MD, PhD         
Principal Investigator: Frederic Amant, MD, PhD         
Sub-Investigator: Kristel Van Calsteren, MD         
Sub-Investigator: Michael Halaska, MD         
Sub-Investigator: Laurence Claes, PhD         
Sub-Investigator: Monica Fumagalli, MD PhD         
Mexico
Regional Hospital of High Specialty of Ixtapaluca Recruiting
Ixtapaluca, Mexico, 56530
Contact: Álvaro Cabrera Garciá, MD         
Netherlands
Erasmus Medical Center Recruiting
Rotterdam, Netherlands
Contact: Ingrid Boere, MD PHD       cip@nki.nl   
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         
Russian Federation
Research Center for Obstetrics, Gynecology and Perinatology Recruiting
Moscow, Russian Federation
Contact: Roman Shmakov, MD         
Sponsors and Collaborators
University Hospital, Gasthuisberg
Laurence Claes, PhD
Ingrid Boere, MD PhD
Michael Halaska, MD PhD
Lagae, Lieven, M.D., Ph.D.
Mertens, Luc, M.D., Ph.D.
Monica Fumagalli, MD PhD
Kristel Van Calsteren, MD PhD
Christianne Lok, MD PhD
Robert Fruscio, MD PhD
Marry van den Heuvel-Eibrink, MD PhD
Investigators
Principal Investigator: Amant Frederic, MD PhD KULeuven, Belgium

Additional Information:
Publications of Results:
Vandenbroucke, T., Verheecke, M., Fumagalli, M., Lok, C., & Amant, F. (2017) Effects of cancer treatment during pregnancy on fetal and child development. The Lancet Child and Adolescent Health 2017, 1, 302-310. DOI:10.1016/S2352-4642(17)30091-3

Other Publications:

Responsible Party: Frederic Amant, MD PhD, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT00330447     History of Changes
Other Study ID Numbers: cancer in pregnancy
First Posted: May 26, 2006    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018

Keywords provided by Frederic Amant, University Hospital, Gasthuisberg:
pregnancy
in utero
chemotherapy
radiotherapy
cancer
offspring
neonatal
long term
follow up
cancer during pregnancy
chemotherapy and radiotherapy during pregnancy
long term follow up of children