Genomic and Epigenomic Alterations After Cancer Treatment in Pregnancy

NCT04125446 | Unknown

• 1 other identifier: S62388
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Pregnancy

Keywords

cancer in pregnancy; chemotherapy; offspring; genotoxicity

Outcome Measures

Primary Outcomes (1)

• 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

  through study completion, an average of 5 years

Secondary Outcomes (1)

• Measuring concentration of chemotherapeutic drugs in offspring tissue (cord blood, meconium) in patients receiving cisplatin, carboplatin and/or cyclophosphamide treatment.

  through study completion, an average of 5 years

Study Arms (3)

Cancer in pregnancy chemo treated

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

Cancer in Pregnancy not chemo treated

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

healthy pregnancies

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Cancer in pregnancy - CT-treated arm
• Histological proven cancer during pregnancy (any type and stage)
• (Former) participation in part I.IA of the CIP-study S25470 (and I.IB for the placental sub study)
• Treatment during pregnancy with one or a combination of the following chemotherapeutic agents:
• Cyclophosphamide
• Anthracyclines
• Taxanes
• Platinum derivates
• Gestational age (GA) at birth ≥24 weeks Cancer in pregnancy - CT-untreated arm
• No treatment during pregnancy or surgery only (subgroup 1)
• Radiotherapy and/or systemic treatment (other than CT) during pregnancy (subgroup 2)
• GA at birth ≥24 weeks Healthy pregnant controls
• matched for maternal age, gestation at birth and infant gender with CT-treated arm
• GA at birth ≥24 weeks (only for placental study)

You may not qualify if:

• GA at birth \<24 weeks (miscarriage or termination of pregnancy) (placental study)
• Mentally disabled women or patients who have a significantly altered mental status that would prohibit the understanding and giving of informed consent
• Any comorbidity that is associated with an enhanced risk of placental pathology or FGR such as hypertensive disorders, preeclampsia, (gestational) diabetes, SLE, Crohn's disease, renal or cardiac pathology (healthy pregnant controls)

Sponsors & Collaborators

• University Hospital, Gasthuisberg: lead
• University Hospital, Antwerp: collaborator
• University Hospital, Ghent: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Parental blood, cord blood, meconium, buccal swabs

MeSH Terms

Conditions

Neoplasms

Study Officials

• Frédéric Amant, MD,PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilana Struys

CONTACT

+32 478734460; ilana.struys@uzleuven.be

Liesbeth Lenaerts, PhD,Ir

CONTACT

+32 16 344468; liesbeth.lenaerts@kuleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Principal Investigator

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 14, 2019
• Study Start: October 15, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 27, 2022

Record last verified: 2022-09

Locations

BE (1)