Clinical trial NCT00330447: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Pregnancy
Keywords: pregnancy
in utero
chemotherapy
radiotherapy
cancer
offspring
neonatal
long term
follow up
cancer during pregnancy
chemotherapy and radiotherapy during pregnancy
long term follow up of children
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
Collaborators: name: The Netherlands Cancer Institute
name: Erasmus Medical Center
name: San Gerardo Hospital
name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Charles University, Czech Republic
First posted: 2006-05-26
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premenopausal women with a cancer diagnosis in association with cancer

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 4.4):

\*\*\*\*\*\*\*\*\*\*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.

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. From the age of 12 years, informed assent is additionally asked from the child. After the age of 18 years, informed consent is solely asked of the offspring.

Exclusion Criteria:

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

Primary outcomes:
measure: Follow-up of the mothers diagnosed with cancer during pregnancy
timeFrame: anticipated
measure: Follow-up of the children antenatally exposed to chemotherapy or radiotherapy
timeFrame: anticipated
Secondary outcomes:
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper University Hospital (2015-ongoing)
state: New Jersey
city: Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming
city: Graz
country: Austria
facility: Universitätsklinik für Frauenheilkunde und Geburtshilfe (retrospective 2016-2018)
city: Brussels
country: Belgium
facility: UCL Brussels (2013-ongoing)
city: Leuven
country: Belgium
facility: UZ Gasthuisberg, Katholieke Universiteit Leuven (2004-ongoing)
city: Ostrava
country: Czechia
facility: University Hospital Ostrava (2018-ongoing)
city: Prague
country: Czechia
facility: 3rd medical faculty of Charles University (2010-ongoing)
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital (2015-ongoing)
city: Paris
country: France
facility: Hopital Bichat-Claude-Bernard (retrospective until 2018)
city: Freiburg
country: Germany
facility: Universitätsklinik Freiburg (retrospective until 2018)
city: Athens
country: Greece
facility: Euroclinic Hospital (2016-ongoing)
city: Athens
country: Greece
facility: Hellenic Anticancer-Oncological Hospital of Athens (retrospective 2015-2018)
city: Ioánnina
country: Greece
facility: Ioannina University Hospital (retrosepctive 2015-2018)
city: Thessaloníki
country: Greece
facility: Hippokration Hospital (retrospective 2015-2018)
city: Milan
country: Italy
facility: European Institute of Oncology (2010-ongoing)
city: Milan
country: Italy
facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore (2012-ongoing)
city: Milan
country: Italy
facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Milano (2017-ongoing)
city: Milan
country: Italy
facility: San Raffaele Hospital (2017-ongoing)
city: Torino
country: Italy
facility: CIttà della Salute e della Scienza di Torino (2015-ongoing)
city: Ixtapaluca
country: Mexico
facility: Regional Hospital of High Specialty of Ixtapaluca (2018-ongoing)
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center (2014-ongoing)
city: Bergen
country: Norway
facility: Haukeland University Hospital (2017-ongoing)
city: Kraków
country: Poland
facility: Medyczne Macierzynstwo (retrospective 2010-2018)
city: Kraków
country: Poland
facility: University Hospital Krakow (2018-ongoing)
city: Poznań
country: Poland
facility: Pozanan University of Medical Sciences (2017-ongoing)
city: Vila Franca De Xira
country: Portugal
facility: Hospital de Vila Franca de Xira (2017-ongoing)
city: Moscow
country: Russian Federation
facility: N.N.Blokchin National Medical Research Center of Oncology (2013-2018 retrospective; 2018-ongoing prospective)
city: Moscow
country: Russian Federation
facility: Research Center for Obstetrics, Gynecology and Perinatology (2014-ongoing)
city: Saint Petersburg
country: Russian Federation
facility: Almazov National Medical Research Center (2018-ongoing)
city: Stockholm
country: Sweden
facility: Karolinska University Hospital (2017-ongoing)
city: Sousse
country: Tunisia
facility: F.Hached University Teaching Hospital (retrospective 2016-2018)
city: Edirne
country: Turkey
facility: Trakya University Faculty of Medicine (retrospective 2015-2018)
city: Kharkov
country: Ukraine
facility: Grigoriev Institute for medical Radiology (retrospective until 2018)
Study officials:
affiliation: KULeuven, Belgium
name: Amant Frederic, MD PhD
role: PRINCIPAL_INVESTIGATOR
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citation: Verheecke M, Cortes Calabuig A, Finalet Ferreiro J, Brys V, Van Bree R, Verbist G, Everaert T, Leemans L, Gziri MM, Boere I, Halaska MJ, Vanhoudt J, Amant F, Van Calsteren K. Genetic and microscopic assessment of the human chemotherapy-exposed placenta reveals possible pathways contributive to fetal growth restriction. Placenta. 2018 Apr;64:61-70. doi: 10.1016/j.placenta.2018.03.002. Epub 2018 Mar 9.
citation: Vandenbroucke T, Verheecke M, Fumagalli M, Lok C, Amant F. Effects of cancer treatment during pregnancy on fetal and child development. Lancet Child Adolesc Health. 2017 Dec;1(4):302-310. doi: 10.1016/S2352-4642(17)30091-3. Epub 2017 Sep 29.
citation: Gziri MM, Brunee L, Cayphas C, Prigogine T, Van Raemdonck D, Amant F, Hubinont C. Low-grade bronchial mucoepidermoid carcinoma during pregnancy successfully treated by lobectomy. J Obstet Gynaecol. 2017 Nov;37(8):1082-1084. doi: 10.1080/01443615.2017.1308325. Epub 2017 Jun 1. No abstract available.
citation: de Haan J, Van Calsteren K, Lok CAR, de Groot CJM, Amant F. Comment on "Maternal and perinatal outcomes in pregnancy-associated melanoma. Report of two cases and a systematic literature review". Eur J Obstet Gynecol Reprod Biol. 2017 Sep;216:261-262. doi: 10.1016/j.ejogrb.2017.07.025. Epub 2017 Jul 23. No abstract available.
citation: Vandenbroucke T, Han SN, Van Calsteren K, Wilderjans TF, Van den Bergh BRH, Claes L, Amant F. Psychological distress and cognitive coping in pregnant women diagnosed with cancer and their partners. Psychooncology. 2017 Aug;26(8):1215-1221. doi: 10.1002/pon.4301. Epub 2016 Nov 21.
citation: Gziri MM, Han SN, Amant F. Use of general anesthesia and sentinel node procedure during pregnancy. J Surg Oncol. 2012 Dec;106(8):1008. doi: 10.1002/jso.23164. Epub 2012 Jun 4. No abstract available.
citation: Lambrechts S, Van Calsteren K, Capoen A, Op De Beeck K, Joniau S, Timmerman D, Amant F. Polypoid endometriosis of the bladder during pregnancy mimicking urachal carcinoma. Ultrasound Obstet Gynecol. 2011 Oct;38(4):475-8. doi: 10.1002/uog.8985. Epub 2011 Sep 6.
citation: Van Calsteren K, Verbesselt R, Van Bree R, Heyns L, de Bruijn E, de Hoon J, Amant F. Substantial variation in transplacental transfer of chemotherapeutic agents in a mouse model. Reprod Sci. 2011 Jan;18(1):57-63. doi: 10.1177/1933719110379650. Epub 2010 Sep 8.
citation: Van Calsteren K, Verbesselt R, Beijnen J, Devlieger R, De Catte L, Chai DC, Van Bree R, Heyns L, de Hoon J, Amant F. Transplacental transfer of anthracyclines, vinblastine, and 4-hydroxy-cyclophosphamide in a baboon model. Gynecol Oncol. 2010 Dec;119(3):594-600. doi: 10.1016/j.ygyno.2010.08.019. Epub 2010 Sep 17.
citation: Calsteren KV, Verbesselt R, Devlieger R, De Catte L, Chai DC, Van Bree R, Heyns L, Beijnen J, Demarsin S, de Bruijn E, de Hoon J, Amant F. Transplacental transfer of paclitaxel, docetaxel, carboplatin, and trastuzumab in a baboon model. Int J Gynecol Cancer. 2010 Dec;20(9):1456-64. doi: 10.1111/IGC.0b013e3181fb18c8.
citation: Van Calsteren K, Verbesselt R, Ottevanger N, Halaska M, Heyns L, Van Bree R, de Bruijn E, Chai D, Delforge M, Noens L, Renard V, Witteveen E, Rob L, de Hoon J, Amant F. Pharmacokinetics of chemotherapeutic agents in pregnancy: a preclinical and clinical study. Acta Obstet Gynecol Scand. 2010 Oct;89(10):1338-45. doi: 10.3109/00016349.2010.512070.
citation: Van Calsteren K, Hanssens M, Moerman P, Orye G, Bielen D, Vergote I, Amant F. Successful conservative treatment of endocervical adenocarcinoma stage Ib1 diagnosed early in pregnancy. Acta Obstet Gynecol Scand. 2008;87(2):250-3. doi: 10.1080/00016340701870794.
citation: Van Calsteren K, Van Mensel K, Joniau S, Oyen R, Hanssens M, Amant F, Van Poppel H. Urachal carcinoma during pregnancy. Urology. 2006 Jun;67(6):1290.e19-21. doi: 10.1016/j.urology.2005.12.041.
citation: Vandenbroucke T, Verheecke M, van Gerwen M, Van Calsteren K, Halaska MJ, Fumagalli M, Fruscio R, Gandhi A, Veening M, Lagae L, Ottevanger PB, Voigt JU, de Haan J, Gziri MM, Maggen C, Mertens L, Naulaers G, Claes L, Amant F; International Network on Cancer, Infertility and Pregnancy (INCIP). Child development at 6 years after maternal cancer diagnosis and treatment during pregnancy. Eur J Cancer. 2020 Oct;138:57-67. doi: 10.1016/j.ejca.2020.07.004. Epub 2020 Aug 25.