Effects of Oncological Treatment During Pregnancy on Mother and Child
Study Details
Study Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Studygroup Cancer in Pregnancy - all diagnoses and treatments Children born from mothers diagnosed with cancer during pregnancy |
|
| Control group Children from the general population |
Outcome Measures
Primary Outcome Measures
- Follow-up of the mothers diagnosed with cancer during pregnancy [anticipated]
treatment during pregnancy, obstetrical outcome, maternal survival
- Follow-up of the children antenatally exposed to chemotherapy or radiotherapy [anticipated]
neurologic and cardiologic outcome
Eligibility Criteria
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
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Patients who have given their signed and written informed consent to participate in the trial after fully understanding the implication of the protocol
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cooper University Hospital (2015-ongoing) | Camden | New Jersey | United States | 08103 |
| 2 | Instituto Alexander Fleming | Buenos Aires | Argentina | ||
| 3 | Universitätsklinik für Frauenheilkunde und Geburtshilfe (retrospective 2016-2018) | Graz | Austria | ||
| 4 | UCL Brussels (2013-ongoing) | Brussels | Belgium | ||
| 5 | UZ Gasthuisberg, Katholieke Universiteit Leuven (2004-ongoing) | Leuven | Belgium | 3000 | |
| 6 | University Hospital Ostrava (2018-ongoing) | Ostrava | Czechia | ||
| 7 | 3rd medical faculty of Charles University (2010-ongoing) | Prague | Czechia | ||
| 8 | Copenhagen University Hospital (2015-ongoing) | Copenhagen | Denmark | ||
| 9 | Hopital Bichat-Claude-Bernard (retrospective until 2018) | Paris | France | ||
| 10 | Universitätsklinik Freiburg (retrospective until 2018) | Freiburg | Germany | ||
| 11 | Euroclinic Hospital (2016-ongoing) | Athens | Greece | ||
| 12 | Hellenic Anticancer-Oncological Hospital of Athens (retrospective 2015-2018) | Athens | Greece | ||
| 13 | Ioannina University Hospital (retrosepctive 2015-2018) | Ioánnina | Greece | ||
| 14 | Hippokration Hospital (retrospective 2015-2018) | Thessaloníki | Greece | ||
| 15 | European Institute of Oncology (2010-ongoing) | Milan | Italy | ||
| 16 | Fondazione IRCCS Ca'Granda Ospedale Maggiore (2012-ongoing) | Milan | Italy | ||
| 17 | Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Milano (2017-ongoing) | Milan | Italy | ||
| 18 | San Raffaele Hospital (2017-ongoing) | Milan | Italy | ||
| 19 | CIttà della Salute e della Scienza di Torino (2015-ongoing) | Torino | Italy | ||
| 20 | Regional Hospital of High Specialty of Ixtapaluca (2018-ongoing) | Ixtapaluca | Mexico | 56530 | |
| 21 | Erasmus Medical Center (2014-ongoing) | Rotterdam | Netherlands | ||
| 22 | Haukeland University Hospital (2017-ongoing) | Bergen | Norway | ||
| 23 | Medyczne Macierzynstwo (retrospective 2010-2018) | Kraków | Poland | ||
| 24 | University Hospital Krakow (2018-ongoing) | Kraków | Poland | ||
| 25 | Pozanan University of Medical Sciences (2017-ongoing) | Poznań | Poland | ||
| 26 | Hospital de Vila Franca de Xira (2017-ongoing) | Vila Franca De Xira | Portugal | ||
| 27 | N.N.Blokchin National Medical Research Center of Oncology (2013-2018 retrospective; 2018-ongoing prospective) | Moscow | Russian Federation | ||
| 28 | Research Center for Obstetrics, Gynecology and Perinatology (2014-ongoing) | Moscow | Russian Federation | ||
| 29 | Almazov National Medical Research Center (2018-ongoing) | Saint Petersburg | Russian Federation | ||
| 30 | Karolinska University Hospital (2017-ongoing) | Stockholm | Sweden | ||
| 31 | F.Hached University Teaching Hospital (retrospective 2016-2018) | Sousse | Tunisia | ||
| 32 | Trakya University Faculty of Medicine (retrospective 2015-2018) | Edirne | Turkey | ||
| 33 | Grigoriev Institute for medical Radiology (retrospective until 2018) | Kharkov | Ukraine |
Sponsors and Collaborators
- University Hospital, Gasthuisberg
- 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Amant F, Brepoels L, Halaska MJ, Gziri MM, Calsteren KV. Gynaecologic cancer complicating pregnancy: an overview. Best Pract Res Clin Obstet Gynaecol. 2010 Feb;24(1):61-79. doi: 10.1016/j.bpobgyn.2009.08.001. Epub 2009 Sep 8. Review.
- Amant F, Deckers S, Van Calsteren K, Loibl S, Halaska M, Brepoels L, Beijnen J, Cardoso F, Gentilini O, Lagae L, Mir O, Neven P, Ottevanger N, Pans S, Peccatori F, Rouzier R, Senn HJ, Struikmans H, Christiaens MR, Cameron D, Du Bois A. Breast cancer in pregnancy: recommendations of an international consensus meeting. Eur J Cancer. 2010 Dec;46(18):3158-68. doi: 10.1016/j.ejca.2010.09.010.
- Amant F, Halaska MJ, Fumagalli M, Dahl Steffensen K, Lok C, Van Calsteren K, Han SN, Mir O, Fruscio R, Uzan C, Maxwell C, Dekrem J, Strauven G, Mhallem Gziri M, Kesic V, Berveiller P, van den Heuvel F, Ottevanger PB, Vergote I, Lishner M, Morice P, Nulman I; ESGO task force 'Cancer in Pregnancy'. Gynecologic cancers in pregnancy: guidelines of a second international consensus meeting. Int J Gynecol Cancer. 2014 Mar;24(3):394-403. doi: 10.1097/IGC.0000000000000062. Review. Erratum in: Int J Gynecol Cancer. 2014 May;24(4):819.
- Amant F, Han SN, Gziri MM, Dekrem J, Van Calsteren K. Chemotherapy during pregnancy. Curr Opin Oncol. 2012 Sep;24(5):580-6. doi: 10.1097/CCO.0b013e328354e754. Review.
- Amant F, Han SN, Gziri MM, Vandenbroucke T, Verheecke M, Van Calsteren K. Management of cancer in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2015 Jul;29(5):741-53. doi: 10.1016/j.bpobgyn.2015.02.006. Epub 2015 Mar 4. Review.
- Amant F, Loibl S, Neven P, Van Calsteren K. Breast cancer in pregnancy. Lancet. 2012 Feb 11;379(9815):570-9. doi: 10.1016/S0140-6736(11)61092-1. Review.
- Amant F, Van Calsteren K, Halaska MJ, Beijnen J, Lagae L, Hanssens M, Heyns L, Lannoo L, Ottevanger NP, Vanden Bogaert W, Ungar L, Vergote I, du Bois A. Gynecologic cancers in pregnancy: guidelines of an international consensus meeting. Int J Gynecol Cancer. 2009 May;19 Suppl 1:S1-12. doi: 10.1111/IGC.0b013e3181a1d0ec.
- Amant F, Van Calsteren K, Vergote I, Ottevanger N. Gynecologic oncology in pregnancy. Crit Rev Oncol Hematol. 2008 Sep;67(3):187-95. doi: 10.1016/j.critrevonc.2008.01.006. Epub 2008 Mar 4. Review.
- Amant F, Verheecke M, Wlodarska I, Dehaspe L, Brady P, Brison N, Van Den Bogaert K, Dierickx D, Vandecaveye V, Tousseyn T, Moerman P, Vanderstichele A, Vergote I, Neven P, Berteloot P, Putseys K, Danneels L, Vandenberghe P, Legius E, Vermeesch JR. Presymptomatic Identification of Cancers in Pregnant Women During Noninvasive Prenatal Testing. JAMA Oncol. 2015 Sep;1(6):814-9. doi: 10.1001/jamaoncol.2015.1883.
- Amant F. Safety of chemotherapy in pregnancy. Clin Adv Hematol Oncol. 2012 Apr;10(4):258-9.
- Boere I, Lok C, Vandenbroucke T, Amant F. Cancer in pregnancy: safety and efficacy of systemic therapies. Curr Opin Oncol. 2017 Sep;29(5):328-334. doi: 10.1097/CCO.0000000000000386. Review.
- Caluwaerts S, VAN Calsteren K, Mertens L, Lagae L, Moerman P, Hanssens M, Wuyts K, Vergote I, Amant F. Neoadjuvant chemotherapy followed by radical hysterectomy for invasive cervical cancer diagnosed during pregnancy: report of a case and review of the literature. Int J Gynecol Cancer. 2006 Mar-Apr;16(2):905-8.
- de Haan J, Vandecaveye V, Han SN, Van de Vijver KK, Amant F. Difficulties with diagnosis of malignancies in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2016 May;33:19-32. doi: 10.1016/j.bpobgyn.2015.10.005. Epub 2015 Oct 19. Review.
- de Haan J, Verheecke M, Amant F. Management of ovarian cysts and cancer in pregnancy. Facts Views Vis Obgyn. 2015;7(1):25-31. Review.
- Deckers S, Amant F. Breast cancer in pregnancy: a literature review. Facts Views Vis Obgyn. 2009;1(2):130-41. Review.
- Fruscio R, de Haan J, Van Calsteren K, Verheecke M, Mhallem M, Amant F. Ovarian cancer in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2017 May;41:108-117. doi: 10.1016/j.bpobgyn.2016.09.013. Epub 2016 Oct 1. Review.
- Gziri MM, Goffin F, Debieve F, Amant F. [Cancer diagnosis during pregnancy: importance of a national and European registration]. Rev Med Liege. 2013 Oct;68(10):527-30. French.
- Han SN, Gziri MM, Van Calsteren K, Amant F. Is chemotherapy during the first trimester of pregnancy really safe? Int J Cancer. 2013 Apr 1;132(7):1728. doi: 10.1002/ijc.27815. Epub 2012 Sep 28.
- Han SN, Kesic VI, Van Calsteren K, Petkovic S, Amant F; ESGO 'Cancer in Pregnancy' Task Force. Cancer in pregnancy: a survey of current clinical practice. Eur J Obstet Gynecol Reprod Biol. 2013 Mar;167(1):18-23. doi: 10.1016/j.ejogrb.2012.10.026. Epub 2012 Nov 19.
- Han SN, Lotgerink A, Gziri MM, Van Calsteren K, Hanssens M, Amant F. Physiologic variations of serum tumor markers in gynecological malignancies during pregnancy: a systematic review. BMC Med. 2012 Aug 8;10:86. doi: 10.1186/1741-7015-10-86.
- Han SN, Mhallem Gziri M, Van Calsteren K, Amant F. Cervical cancer in pregnant women: treat, wait or interrupt? Assessment of current clinical guidelines, innovations and controversies. Ther Adv Med Oncol. 2013 Jul;5(4):211-9. doi: 10.1177/1758834013494988.
- Han SN, Van Calsteren K, Amant F. Use of chemotherapy during pregnancy in the treatment of ovarian malignancies. Eur J Obstet Gynecol Reprod Biol. 2011 Jun;156(2):237. doi: 10.1016/j.ejogrb.2011.02.004. Epub 2011 Mar 25.
- Han SN, Van Peer S, Peccatori F, Gziri MM, Amant F; International Network on Cancer, Infertility and Pregnancy. Contraception is as important as fertility preservation in young women with cancer. Lancet. 2015 Feb 7;385(9967):508. doi: 10.1016/S0140-6736(15)60201-X.
- Han SN, Verheecke M, Vandenbroucke T, Gziri MM, Van Calsteren K, Amant F. Management of gynecological cancers during pregnancy. Curr Oncol Rep. 2014 Dec;16(12):415. doi: 10.1007/s11912-014-0415-z. Review.
- Lishner M, Avivi I, Apperley JF, Dierickx D, Evens AM, Fumagalli M, Nulman I, Oduncu FS, Peccatori FA, Robinson S, Van Calsteren K, Vandenbroucke T, Van den Heuvel F, Amant F. Hematologic Malignancies in Pregnancy: Management Guidelines From an International Consensus Meeting. J Clin Oncol. 2016 Feb 10;34(5):501-8. doi: 10.1200/JCO.2015.62.4445. Epub 2015 Nov 30.
- Loibl S, Han SN, Amant F. Being Pregnant and Diagnosed with Breast Cancer. Breast Care (Basel). 2012 Jun;7(3):204-209. Epub 2012 Jun 27.
- Van Calsteren K, Amant F. Cancer during pregnancy. Acta Obstet Gynecol Scand. 2014 May;93(5):443-6. doi: 10.1111/aogs.12380.
- Van Calsteren K, Berteloot P, Hanssens M, Vergote I, Amant F, Ganame J, Claus P, Mertens L, Lagae L, Delforge M, Paridaens R, Noens L, Humblet Y, Vandermeersch B, De Muylder X. In utero exposure to chemotherapy: effect on cardiac and neurologic outcome. J Clin Oncol. 2006 Apr 20;24(12):e16-7.
- Van Calsteren K, Devlieger R, De Catte L, D'Hooghe T, Chai DC, Mwenda JM, Vergote I, Amant F. Feasibility of ultrasound-guided percutaneous samplings in the pregnant baboon: a model for studies on transplacental transport. Reprod Sci. 2009 Mar;16(3):280-5. doi: 10.1177/1933719108324890. Epub 2008 Dec 15.
- Van Calsteren K, Hartmann D, Van Aerschot L, Verbesselt R, Van Bree R, D'Hooge R, Amant F. Vinblastine and doxorubicin administration to pregnant mice affects brain development and behaviour in the offspring. Neurotoxicology. 2009 Jul;30(4):647-57. doi: 10.1016/j.neuro.2009.04.009. Epub 2009 May 5.
- van Dam L, Han SN, Dierickx D, Amant F. Optimal staging of lymphoma during pregnancy is crucial. Womens Health (Lond). 2015 Mar;11(2):101-2. doi: 10.2217/whe.14.77.
- Vandenbriele C, Dierickx D, Amant F, Delforge M. The treatment of hematologic malignancies in pregnancy. Facts Views Vis Obgyn. 2010;2(2):74-87. Review.
- Vercruysse DC, Deprez S, Sunaert S, Van Calsteren K, Amant F. Effects of prenatal exposure to cancer treatment on neurocognitive development, a review. Neurotoxicology. 2016 May;54:11-21. doi: 10.1016/j.neuro.2016.02.013. Epub 2016 Mar 4. Review.
- Verheecke M, Hermans E, Tuyaerts S, Souche E, Van Bree R, Verbist G, Everaert T, Cortès-Calabuig A, Van Houdt J, Van Calsteren K, Amant F. Acute Drug Effects on the Human Placental Tissue: The Development of a Placental Murine Xenograft Model. Reprod Sci. 2018 Dec;25(12):1637-1648. doi: 10.1177/1933719118756771. Epub 2018 Feb 13.
- cancer in pregnancy