Genomic and Epigenomic Alterations After Cancer Treatment in Pregnancy (GE-CIP)
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| ClinicalTrials.gov Identifier: NCT04125446 |
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Recruitment Status :
Recruiting
First Posted : October 14, 2019
Last Update Posted : September 27, 2022
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| Tracking Information | |||||||||
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| First Submitted Date | October 10, 2019 | ||||||||
| First Posted Date | October 14, 2019 | ||||||||
| Last Update Posted Date | September 27, 2022 | ||||||||
| Actual Study Start Date | October 15, 2019 | ||||||||
| Estimated Primary Completion Date | December 31, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Assessing general genotoxicity of fetal DNA; genomic instability, de novo somatic mutations and methylation changes related to in utero exposure to chemotherapy [ Time Frame: through study completion, an average of 5 years ] somatic mutations, structural alterations, methylation changes
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| Original Primary Outcome Measures |
(epi)genetic alterations in offspring DNA (placenta, cord blood, buccal swabs) [ Time Frame: through study completion, an average of 5 years ] somatic mutations, structural alterations, methylation changes
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| Change History | |||||||||
| Current Secondary Outcome Measures |
Measuring concentration of chemotherapeutic drugs in offspring tissue (cord blood, meconium) in patients receiving cisplatin, carboplatin and/or cyclophosphamide treatment. [ Time Frame: through study completion, an average of 5 years ] DNA adduct
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| Original Secondary Outcome Measures |
concentration of chemotherapeutic drugs in offspring tissue (placanta, cord blood, meconium) [ Time Frame: through study completion, an average of 5 years ] DNA adduct
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Genomic and Epigenomic Alterations After Cancer Treatment in Pregnancy | ||||||||
| Official Title | Genomic and Epigenomic Alterations After Cancer Treatment in Pregnancy | ||||||||
| 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 and/or offspring (epi)genetic changes, potentially causing FGR and childhood/adult diseases later in life. | ||||||||
| Detailed Description | 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. |
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| Study Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 9 Months | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Parental blood, cord blood, meconium, buccal swabs
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | 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. | ||||||||
| Condition |
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| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
150 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 31, 2023 | ||||||||
| Estimated Primary Completion Date | December 31, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
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| Listed Location Countries | Belgium | ||||||||
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| Administrative Information | |||||||||
| NCT Number | NCT04125446 | ||||||||
| Other Study ID Numbers | S62388 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Current Responsible Party | Frederic Amant, University Hospital, Gasthuisberg | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | University Hospital, Gasthuisberg | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators |
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| Investigators |
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| PRS Account | University Hospital, Gasthuisberg | ||||||||
| Verification Date | September 2022 | ||||||||