Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Paclitaxel

Cyclophosphamide

Carboplatin

Albumin-Bound Paclitaxel

Cisplatin

Patients that received at least one of the following treatments: Carboplatin, Cisplatin, Cyclophosphamide, Paclitaxel and/or anthracyclines, the latter being the most given type of CT during pregnancy

Women who were not treated with CT during pregnancy, including those who were solely surgically treated or did not receive any treatment during pregnancy, will be included in the CT-unexposed control arm

A group of healthy pregnant women without cancer will form the second control group

Ilana Struys

Liesbeth Lenaerts, PhD,Ir

Frédéric Amant, MD,PhD

Kristel Van Calsteren, MD,PhD

Bernard Thienpont, PhD,Ir

Lode Godderis, MD,PhD

Thierry Voet, PhD,Ir

The investigators want to obtain a fundamental understanding if and which chemotherapeutic agents used for treating cancer during pregnancy are associated with placental and/or offspring (epi)genetic changes, potentially causing FGR and childhood/adult diseases later in life.

Rationale: Cancer is the second leading cause of death during the reproductive years and affects between 1:1000 and 2000 pregnant women. Previous studies from our group have shown that chemotherapeutic cancer treatment in pregnancy has reassuring outcomes in terms of cognitive and cardiac neonatal outcomes, and hence has been proposed as standard of care. However fetal growth restriction (FGR), which places an infant at significant risk of perinatal morbidity and mortality, is more common in women who were systemically treated during pregnancy compared to the non-cancer population. The possibility that chemotherapy during pregnancy causes placental (epi)genetic damage, and consequently induces FGR, or affects offspring DNA leading to potential deleterious effects later in life, such as cancer or other diseases, has not been investigated so far. As the cytotoxic effects of chemotherapy at DNA level have been well established, it could be speculated that chemotherapy-induced DNA damage may interfere with fetal and childhood health in the long term. The results of this study will lead to an increased understanding of potential toxic effects of chemotherapy for the unborn child and may therefore contribute to the development of safe and solid treatment regimens for pregnant cancer patients and their children.

Objectives: To obtain a fundamental understanding if and which chemotherapeutic agents used for treating cancer during pregnancy are associated with offspring (epi)genetic changes, potentially causing FGR and childhood/adult diseases later in life.

Study design: This international multicentre prospective observational trial functions as an extension of the CIP-study (Cancer in Pregnancy, S25470) and aims to collect cord blood, meconium and neonatal buccal cells at birth. Parental peripheral blood and buccal cells will be collected and used as reference. Minimal requirement to participate in this study is participation in Part I.IA of the original CIP-study. Through this CIP-study we are able to gather pregnancy-, malignancy- and placenta-related data.

Study population: All patients with histological proven cancer during pregnancy and an ongoing pregnancy (≥24 weeks of gestation) treated with chemotherapy (alkylating agents, anthracyclines, taxanes and/or platinum derivates) or other treatment options (surgery, radiotherapy and/orsystemic treatment other than chemotherapy, or none).

Main study parameters/endpoints: determination of potential (epi)genetic alterations in cord bloodand buccal cells of the newborn, and the association with chemotherapy concentrations measured in newborn tissue.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no risks associated nor benefits expected with participation in this study.

Parental blood, cord blood, meconium, buccal swabs

Genomic and Epigenomic Alterations After Cancer Treatment in Pregnancy

somatic mutations, structural alterations, methylation changes

University Hospital, Antwerp

University Hospital, Ghent

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

University Hospital, Gasthuisberg

Clinical Professor, Principal Investigator

Cancer in Pregnancy - all diagnoses and treatments Children born from mothers diagnosed with cancer during pregnancy

Ayaka Wakatsuki

Kristel Van Calsteren, MD PhD

Elyce Cardonick, MD

Mina Mhallem

Frederic Amant, MD, PhD

Kristel Van Calsteren, MD, PhD

Lieven Lagae, MD, PhD

Luc Mertens, MD, PhD

Kristel Van Calsteren, MD

Michael Halaska, MD

Monica Fumagalli, MD PhD

Maarten Lambrecht, MD PhD

Jaroslav Klát, MD

Lone Storgaard, MD

Berit Woetmann Pedersen, MD

Mona Aarenstrup, MD

Cristel Maria Soerensen-Hjortshoej, MD

Georeg-Marios Makris, MD

Fedro Peccatori, MD

Monica Fumagalli, MD

Giovanna Scarfone, MD

Giorgia Mangili, MD

Bianca Masturzo, MD

Álvaro Cabrera Garciá, MD

Ingrid Boere, MD PHD

Frédéric Amant, MD PHD

C.A.R. Lok, MD PHD

M.M. Van den Heuvel-Eibrink, MD PHD

C.J.M. De Groot, MD PHD

R.C. Painter, MD PHD

P.B. Ottevanger, MD PHD

P.O. Witteveen, MD PHD

C.P. Schröder, MD PHD

S.J. Gordijn, MD PHD

J. Kroep, MD PHD

R.L.M. Bekkers, MD PHD

A.M.J. Thijs, MD PHD

Line Bjorge

Kolawa Wojciech

Marta Balajewicz-Nowak, MD

Kazimierz Pitynski, MD

Stefan Sajdak, MD

Paula Duarte, MD

Anastasia Parokonnaya, MD

Roman Shmakov, MD

Vladim Bezrukikh

Kenny Rodriguez-Wallberg, MD

Amant Frederic, MD PhD

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 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.

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.

Effects of Oncological Treatment During Pregnancy on Mother and Child

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Genomic and Epigenomic Alterations After Cancer Treatment in Pregnancy	NCT04125446	Cancer Pregnancy		-	University Hospital, Gasthuisberg
Effects of Oncological Treatment During Pregnancy on Mother and Child	NCT00330447	Cancer Pregnancy		18 Years -	University Hospital, Gasthuisberg

Spots Global Cancer Trial Database for offspring

Every month we try and update this database with for offspring cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for offspring

Every month we try and update this database with for offspring cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for offspring cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.