Viewing Study NCT04125446



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Last Modification Date: 2024-10-26 @ 1:20 PM
Study NCT ID: NCT04125446
Status: UNKNOWN
Last Update Posted: 2022-09-27
First Post: 2019-10-10

Brief Title: Genomic and Epigenomic Alterations After Cancer Treatment in Pregnancy
Sponsor: University Hospital Gasthuisberg
Organization: University Hospital Gasthuisberg

Study Overview

Official Title: Genomic and Epigenomic Alterations After Cancer Treatment in Pregnancy
Status: UNKNOWN
Status Verified Date: 2022-09
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: GE-CIP
Brief Summary: The investigators want to obtain a fundamental understanding if and which chemotherapeutic agents used for treating cancer during pregnancy are associated with placental andor offspring epigenetic changes potentially causing FGR and childhoodadult diseases later in life
Detailed Description: Rationale Cancer is the second leading cause of death during the reproductive years and affects between 11000 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 epigenetic 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 epigenetic changes potentially causing FGR and childhoodadult 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 IIA 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 andor platinum derivates or other treatment options surgery radiotherapy andorsystemic treatment other than chemotherapy or none

Main study parametersendpoints determination of potential epigenetic 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None