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

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Infertility

Genital Diseases

Urogenital Diseases

Frederic Amant, MD,PhD

Joosje Heimovaara, MD

Frederic Amant, MD, PhD

Frédéric Amant, MD, PhD

The Advisory Board on Cancer, Infertility and Pregnancy provides a platform where physicians from all over the world can request recommendations regarding the medical care of pregnant women diagnosed with cancer or regarding fertility preservation. The platform will contain different national advisory boards, with their own coordinator and members, as well as an overarching international advisory board with an international coordinator and members from different national boards.

To investigate the impact of this platform, a year after its launch, data regarding the incoming requests will be extracted from the website, as well as all recommendation letters.

The Advisory Board on Cancer, Infertility and Pregnancy (ABCIP)-platform will be a web-based platform where clinicians from all over the world can request advice from a group of experts on the field of Cancer and Pregnancy. The platform will contain different national advisory boards, with their own coordinator and members, as well as an overarching international advisory board with an international coordinator and members from different national boards.

Clinicians can fill in a format (attached) requesting for advice, using only pseudonymized patient data after agreeing a disclaimer:

All information filled in in the 'request advice' format needs to be regarded as anonymous or pseudonymous data. We recommend you to inform your patient and ask for approval when needed, based on the rules and regulations applicable in your country.

The filled out request will be sent to the specific national board of their own country, and if no national board is available, to the overarching international board.

. To investigate the impact of this platform, a year after its launch, data regarding the incoming requests will be extracted from the website, as well as all recommendation letters.

Advisory Board on Cancer, Infertility and Pregnancy

To investigate the impact of this platform, a year after its launch, data regarding the incoming requests will be extracted from the website, as well as all recommendation letters. All requesting physicians will be asked to complete a survey including their experiences with the ABCIP, to what amount they followed the given recommendations and the outcomes of mother (and child)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Genomic and Epigenomic Alterations After Cancer Treatment in Pregnancy	NCT04125446	Cancer Pregnancy		-	University Hospital, Gasthuisberg
Advisory Board on Cancer, Infertility and Pregnancy	NCT04904263	Cancer in Pregn... Fertility Prese... Cancer Pregnancy		-	University Hospital, Gasthuisberg

Spots Global Cancer Trial Database for cancer in pregnancy