An observational study in Cancer and Pregnancy, sponsored by University Hospital, Gasthuisberg. Recruiting at 33 sites in 20 countries. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by University Hospital, Gasthuisberg · Observational
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The researchers aim to investigate the outcome (overall survival) of mothers who are diagnosed and/or treated for cancer during pregnancy. Furthermore they want to test the hypothesis that children who were exposed to cancer or cancer treatment (cytotoxic drugs, radiation therapy, targeted therapy,...) develop normally (neurologic and cardiologic examination).
Study contains several study parts (protocol version 4.4):
**********Part I. Pregnancy, delivery and maternal health********** Part I.I.A. Registration study 'Cancer during pregnancy' mother and neonate None Part I.I.B. Effects of prenatal exposure to cancer treatment on fetal growth. The association between placental pathophysiologic mechanisms (histopathology and immunohistochemistry), circulating maternal factors and fetal growth.
From participating women, a maternal blood sample will be collected during or shortly after birth. Also, an umbilical cord blood sample and placental and umbilical cord biopsies will be drawn.
Part I.II. Measurement of maternal and paternal anxiety and emotional needs when confronted with a cancer diagnosis during pregnancy The participants will be asked to complete questionnaires.
**********Part II. Child********** Long term follow up of children and adolescents in utero exposed to chemotherapy and/or radiotherapy Regular check-ups of the child, at the age of 6 months, 18 months, 3y, 6y, 9y, 12y, 15y, and 18y, and after the age of 18 years: 5-yearly cardiologic assessment and questionnaires (23y, 28y, 33y, 38y, and 43y). Optional at the ages of 9y, 12y, 15y and 18y: MRI session.
Summary part I:
Prospectively the outcome of mothers diagnosed and/or treated for cancer during pregnancy will be registered and investigated.
Summary Part II:
In a prospective trial we invite children that were exposed to cytotoxic drugs or radiotherapy in utero for a standardized neurological and cardiological examination. The examinations will be done by qualified psychologists, neurological and cardiological pediatricians.
10,822 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 5,000 is above 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.
Premenopausal women with a cancer diagnosis in association with cancer
Patients do not need to participate in both; however, preferentially both study parts should be performed.
**************Part I: Pregnancy, delivery and maternal health**************
Patients must meet the following inclusion criteria:
Exclusion Criteria:
**************Part II: Follow-up of children**************
Inclusion Criteria:
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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
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.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Cancer in Pregnancy - all diagnoses and treatments Children born from mothers diagnosed with cancer during pregnancy
Children from the general population
Follow-up of the mothers diagnosed with cancer during pregnancy
treatment during pregnancy, obstetrical outcome, maternal survival
Time frame: anticipated
Follow-up of the children antenatally exposed to chemotherapy or radiotherapy
neurologic and cardiologic outcome
Time frame: anticipated
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Started Aug 2005 (actual). Primary completion is estimated for Apr 2025, 236 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 236 months is above 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.
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University Hospital, Gasthuisberg