An observational study in Cancer and Pregnancy, sponsored by University Hospital, Gasthuisberg. Status unknown at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2022-09-27.
Sponsored by University Hospital, Gasthuisberg · Observational
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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.
10,822 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 150 is below the median of 200 across 2,641 observational studies indexed under Neoplasms.
Browse Neoplasms studies →University Hospital, Gasthuisberg is the lead sponsor of 51 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The current study will focus on 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 (cfr. also Table 1). 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.In the CT-unexposed arm, we will also include women that had systemic treatment other than chemotherapy (e.g. targeted therapies) and/or radiotherapy. A group of healthy pregnant women without cancer, delivering in our participating centres, will form the second control group.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Cancer in pregnancy - CT-treated arm
Platinum derivates
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Assessing general genotoxicity of fetal DNA; genomic instability, de novo somatic mutations and methylation changes related to in utero exposure to chemotherapy
somatic mutations, structural alterations, methylation changes
Time frame: through study completion, an average of 5 years
Measuring concentration of chemotherapeutic drugs in offspring tissue (cord blood, meconium) in patients receiving cisplatin, carboplatin and/or cyclophosphamide treatment.
DNA adduct
Time frame: through study completion, an average of 5 years
Started Oct 2019 (actual). Primary completion is estimated for Dec 2023, 50 months after the start.
Of 1,098 non-industry observational studies under Neoplasms, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 227. This study's planned 50 months is below that.
Counting every sponsor, half of 1,246 studies reached it within 58 months; a quarter within 24 and three quarters within 210.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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University Hospital, Gasthuisberg