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Effects of Oncological Treatment During Pregnancy on Mother and Child

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ClinicalTrials.gov Identifier: NCT00330447
Recruitment Status : Recruiting
First Posted : May 26, 2006
Last Update Posted : November 18, 2020
Sponsor:
Collaborators:
The Netherlands Cancer Institute
Erasmus Medical Center
San Gerardo Hospital
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Milano
Charles University, Czech Republic
Information provided by (Responsible Party):
Frederic Amant, University Hospital, Gasthuisberg

Tracking Information
First Submitted Date May 25, 2006
First Posted Date May 26, 2006
Last Update Posted Date November 18, 2020
Study Start Date August 2005
Estimated Primary Completion Date April 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 18, 2018)
  • Follow-up of the mothers diagnosed with cancer during pregnancy [ Time Frame: anticipated ]
    treatment during pregnancy, obstetrical outcome, maternal survival
  • Follow-up of the children antenatally exposed to chemotherapy or radiotherapy [ Time Frame: anticipated ]
    neurologic and cardiologic outcome
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Oncological Treatment During Pregnancy on Mother and Child
Official Title Oncological Treatment During Pregnancy: Pharmacokinetics of Chemotherapy and Long Term Follow up of the Offspring
Brief Summary 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).
Detailed Description

Study contains several study parts (protocol version 4.2):

**********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 I.III. Biobank 'cancer and pregnancy' From participating women, a tumour biopsy specimen before administration of neoadjuvant therapy will be collected at the time of diagnosis. Also, maternal blood samples will be collected before and/or after treatment.

Part I.IV. Study on the pharmacokinetics of chemotherapeutic agents in pregnant women Approximately 10-12 additional peripheral venous blood withdrawals.

**********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 18months, 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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 18 Years
Biospecimen Retention:   Samples With DNA
Description:

Maternal blood serum and sediment of blood; from 2010 on we collect umbilical cord blood.

Since new approval of protocol version 4.2 (08-02-2018) we collect samples of placental tissue, umbilical cord tissue and membranes.

Sampling Method Non-Probability Sample
Study Population Premenopausal women with a cancer diagnosis in association with cancer
Condition
  • Cancer
  • Pregnancy
Intervention Not Provided
Study Groups/Cohorts
  • Studygroup
    Cancer in Pregnancy - all diagnoses and treatments Children born from mothers diagnosed with cancer during pregnancy
  • Control group
    Children from the general population
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 11, 2014)
5000
Original Enrollment
 (submitted: May 25, 2006)
50
Estimated Study Completion Date December 2032
Estimated Primary Completion Date April 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

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:

  • Histologically proven cancer in association with a pregnancy (during pregnancy or cancer dagnosis within 5 years after pregnancy)
  • > 18 years of age, premenopausal
  • Patients who have given their signed and written informed consent to participate in the trial after fully understanding the implication of the protocol
  • Women receiving any cytotoxic drug or radiation therapy during pregnancy are allowed for the assessment of the maternal and fetal outcome (Part II).

Exclusion Criteria:

  • Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent

**************Part II: Follow-up of children**************

Inclusion Criteria:

- Children that were prenatally exposed to cancer of cancer treament. Informed Consent is asked from parents.

Exclusion Criteria:

  • Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Katrien Van Tornout +32-16-342876 katrien.vantornout@uzleuven.be
Contact: Kristel Van Calsteren, MD PhD +32-16-346192 kristel.vancalsteren@uzleuven.be
Listed Location Countries Argentina,   Austria,   Belgium,   Czechia,   Denmark,   France,   Germany,   Greece,   Italy,   Mexico,   Netherlands,   Norway,   Poland,   Portugal,   Russian Federation,   Sweden,   Tunisia,   Turkey,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00330447
Other Study ID Numbers cancer in pregnancy
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Frederic Amant, University Hospital, Gasthuisberg
Study Sponsor University Hospital, Gasthuisberg
Collaborators
  • The Netherlands Cancer Institute
  • Erasmus Medical Center
  • San Gerardo Hospital
  • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Milano
  • Charles University, Czech Republic
Investigators
Principal Investigator: Amant Frederic, MD PhD KULeuven, Belgium
PRS Account University Hospital, Gasthuisberg
Verification Date November 2020