- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00330447
Effekter af onkologisk behandling under graviditet på mor og barn
Onkologisk behandling under graviditet: Farmakokinetik af kemoterapi og langtidsopfølgning af afkommet
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsen indeholder flere undersøgelsesdele (protokolversion 4.2):
**********Del I. Graviditet, fødsel og mødres sundhed********** Del I.I.A. Registreringsundersøgelse 'Cancer under graviditet' mor og nyfødt Ingen Del I.I.B. Effekter af prænatal eksponering for kræftbehandling på fostervækst. Sammenhængen mellem placenta patofysiologiske mekanismer (histopatologi og immunhistokemi), cirkulerende maternelle faktorer og fostervækst.
Fra deltagende kvinder vil der blive udtaget en moderblodprøve under eller kort efter fødslen. Der vil også blive udtaget en navlestrengsblodprøve og placenta- og navlestrengsbiopsier.
Del I.II. Måling af moderens og faderens angst og følelsesmæssige behov, når de konfronteres med en kræftdiagnose under graviditeten. Deltagerne vil blive bedt om at udfylde spørgeskemaer. Del I.III. Biobank 'kræft og graviditet' Fra deltagende kvinder vil en tumorbiopsiprøve inden administration af neoadjuverende terapi blive indsamlet på diagnosetidspunktet. Der vil også blive indsamlet blodprøver fra moderen før og/eller efter behandlingen.
Del I.IV. Undersøgelse af farmakokinetikken af kemoterapeutiske midler hos gravide. Ca. 10-12 yderligere perifere venøse blodudtagninger.
**********Del II. Barn********** Langtidsopfølgning af børn og unge i livmoderen udsat for kemoterapi og/eller strålebehandling Regelmæssig kontrol af barnet i en alder af 18 måneder, 3 år, 6 år, 9 år, 12 år, 15 år og 18 år og efter 18 års alderen: 5-årig kardiologisk vurdering og spørgeskemaer (23 år, 28 år, 33 år, 38 år og 43 år). Valgfrit i alderen 9 år, 12 år, 15 år og 18 år: MR-session.
Resumé del I:
Fremadrettet vil resultatet af mødre diagnosticeret og/eller behandlet for kræft under graviditeten blive registreret og undersøgt.
Resumé del II:
I et prospektivt forsøg inviterer vi børn, der har været udsat for cellegift eller strålebehandling in utero, til en standardiseret neurologisk og kardiologisk undersøgelse. Undersøgelserne vil blive foretaget af kvalificerede psykologer, neurologiske og kardiologiske børnelæger.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Kristel Van Calsteren, MD PhD
- Telefonnummer: +32-16-346192
- E-mail: kristel.vancalsteren@uzleuven.be
Undersøgelse Kontakt Backup
- Navn: Ayaka Wakatsuki
- Telefonnummer: +32 16 34 41 69
- E-mail: ayaka.wakatsuki@uzleuven.be
Studiesteder
-
-
-
Buenos Aires, Argentina
- Trukket tilbage
- Instituto Alexander Fleming
-
-
-
-
-
Brussels, Belgien
- Rekruttering
- UCL Brussels (2013-ongoing)
-
Kontakt:
- Mina Mhallem
- E-mail: katrien.vantornout@uzleuven.be
-
Leuven, Belgien, 3000
- Rekruttering
- UZ Gasthuisberg, Katholieke Universiteit Leuven (2004-ongoing)
-
Ledende efterforsker:
- Frédéric Amant, MD, PhD
-
Kontakt:
- Frederic Amant, MD, PhD
- Telefonnummer: +32-16-344252
- E-mail: frederic.amant@uzleuven.be
-
Kontakt:
- Kristel Van Calsteren, MD, PhD
- Telefonnummer: +32-16-346192
- E-mail: kristel.vancalsteren@uzleuven.be
-
Underforsker:
- Lieven Lagae, MD, PhD
-
Underforsker:
- Luc Mertens, MD, PhD
-
Underforsker:
- Kristel Van Calsteren, MD
-
Underforsker:
- Michael Halaska, MD
-
Underforsker:
- Monica Fumagalli, MD PhD
-
Underforsker:
- Maarten Lambrecht, MD PhD
-
-
-
-
-
Copenhagen, Danmark
- Rekruttering
- Copenhagen University Hospital (2015-ongoing)
-
Kontakt:
- Lone Storgaard, MD
-
Underforsker:
- Berit Woetmann Pedersen, MD
-
Underforsker:
- Mona Aarenstrup, MD
-
Underforsker:
- Cristel Maria Soerensen-Hjortshoej, MD
-
-
-
-
-
Moscow, Den Russiske Føderation
- Rekruttering
- N.N.Blokchin National Medical Research Center of Oncology (2013-2018 retrospective; 2018-ongoing prospective)
-
Kontakt:
- Anastasia Parokonnaya, MD
-
Moscow, Den Russiske Føderation
- Rekruttering
- Research Center for Obstetrics, Gynecology and Perinatology (2014-ongoing)
-
Kontakt:
- Roman Shmakov, MD
-
Saint Petersburg, Den Russiske Føderation
- Rekruttering
- Almazov National Medical Research Center (2018-ongoing)
-
Kontakt:
- Vladim Bezrukikh
-
-
-
-
New Jersey
-
Camden, New Jersey, Forenede Stater, 08103
- Rekruttering
- Cooper University Hospital (2015-ongoing)
-
Kontakt:
- Elyce Cardonick, MD
-
-
-
-
-
Paris, Frankrig
- Afsluttet
- Hopital Bichat-Claude-Bernard (retrospective until 2018)
-
-
-
-
-
Athens, Grækenland
- Rekruttering
- Euroclinic Hospital (2016-ongoing)
-
Kontakt:
- Georeg-Marios Makris, MD
-
Athens, Grækenland
- Afsluttet
- Hellenic Anticancer-Oncological Hospital of Athens (retrospective 2015-2018)
-
Ioánnina, Grækenland
- Afsluttet
- Ioannina University Hospital (retrosepctive 2015-2018)
-
Thessaloníki, Grækenland
- Afsluttet
- Hippokration Hospital (retrospective 2015-2018)
-
-
-
-
-
Rotterdam, Holland
- Rekruttering
- Erasmus Medical Center (2014-ongoing)
-
Kontakt:
- Ingrid Boere, MD PHD
- E-mail: cip@nki.nl
-
Ledende efterforsker:
- Frédéric Amant, MD PHD
-
Underforsker:
- C.A.R. Lok, MD PHD
-
Underforsker:
- M.M. Van den Heuvel-Eibrink, MD PHD
-
Underforsker:
- C.J.M. De Groot, MD PHD
-
Underforsker:
- R.C. Painter, MD PHD
-
Underforsker:
- P.B. Ottevanger, MD PHD
-
Underforsker:
- P.O. Witteveen, MD PHD
-
Underforsker:
- C.P. Schröder, MD PHD
-
Underforsker:
- S.J. Gordijn, MD PHD
-
Underforsker:
- J. Kroep, MD PHD
-
Underforsker:
- R.L.M. Bekkers, MD PHD
-
Underforsker:
- A.M.J. Thijs, MD PHD
-
-
-
-
-
Milan, Italien
- Rekruttering
- European Institute of Oncology (2010-ongoing)
-
Kontakt:
- Fedro Peccatori, MD
-
Milan, Italien
- Rekruttering
- Fondazione IRCCS Ca'Granda Ospedale Maggiore (2012-ongoing)
-
Kontakt:
- Monica Fumagalli, MD
-
Milan, Italien
- Rekruttering
- Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Milano (2017-ongoing)
-
Kontakt:
- Giovanna Scarfone, MD
-
Milan, Italien
- Rekruttering
- San Raffaele Hospital (2017-ongoing)
-
Kontakt:
- Giorgia Mangili, MD
-
Torino, Italien
- Rekruttering
- CIttà della Salute e della Scienza di Torino (2015-ongoing)
-
Kontakt:
- Bianca Masturzo, MD
-
-
-
-
-
Edirne, Kalkun
- Afsluttet
- Trakya University Faculty of Medicine (retrospective 2015-2018)
-
-
-
-
-
Ixtapaluca, Mexico, 56530
- Rekruttering
- Regional Hospital of High Specialty of Ixtapaluca (2018-ongoing)
-
Kontakt:
- Álvaro Cabrera Garciá, MD
-
-
-
-
-
Bergen, Norge
- Rekruttering
- Haukeland University Hospital (2017-ongoing)
-
Kontakt:
- Line Bjorge
-
-
-
-
-
Kraków, Polen
- Afsluttet
- Medyczne Macierzynstwo (retrospective 2010-2018)
-
Kraków, Polen
- Rekruttering
- University Hospital Krakow (2018-ongoing)
-
Kontakt:
- Kolawa Wojciech
-
Underforsker:
- Marta Balajewicz-Nowak, MD
-
Underforsker:
- Kazimierz Pitynski, MD
-
Poznań, Polen
- Rekruttering
- Pozanan University of Medical Sciences (2017-ongoing)
-
Kontakt:
- Stefan Sajdak, MD
-
-
-
-
-
Vila Franca De Xira, Portugal
- Rekruttering
- Hospital de Vila Franca de Xira (2017-ongoing)
-
Kontakt:
- Paula Duarte, MD
-
-
-
-
-
Stockholm, Sverige
- Rekruttering
- Karolinska University Hospital (2017-ongoing)
-
Kontakt:
- Kenny Rodriguez-Wallberg, MD
-
-
-
-
-
Ostrava, Tjekkiet
- Rekruttering
- University Hospital Ostrava (2018-ongoing)
-
Kontakt:
- Jaroslav Klát, MD
-
Prague, Tjekkiet
- Rekruttering
- 3rd medical faculty of Charles University (2010-ongoing)
-
Kontakt:
- Michael Halaska, MD
-
-
-
-
-
Sousse, Tunesien
- Afsluttet
- F.Hached University Teaching Hospital (retrospective 2016-2018)
-
-
-
-
-
Freiburg, Tyskland
- Afsluttet
- Universitätsklinik Freiburg (retrospective until 2018)
-
-
-
-
-
Kharkov, Ukraine
- Afsluttet
- Grigoriev Institute for medical Radiology (retrospective until 2018)
-
-
-
-
-
Graz, Østrig
- Afsluttet
- Universitätsklinik für Frauenheilkunde und Geburtshilfe (retrospective 2016-2018)
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Patienterne behøver ikke at deltage i begge dele; dog skal begge studiedele fortrinsvis udføres.
**************Del I: Graviditet, fødsel og mødres sundhed**************
Patienter skal opfylde følgende inklusionskriterier:
- Histologisk påvist kræft i forbindelse med en graviditet (under graviditet eller kræftdagnosis inden for 5 år efter graviditet)
- > 18 år, præmenopausal
- Patienter, der har givet deres underskrevne og skriftlige informerede samtykke til at deltage i forsøget efter fuldt ud at have forstået implikationen af protokollen
- Kvinder, der får cellegift eller strålebehandling under graviditeten, får lov til at vurdere det maternelle og fosterlige resultat (del II).
Ekskluderingskriterier:
- Mentalt handicappet eller væsentligt ændret mental status, der ville forhindre forståelse og afgivelse af informeret samtykke
**************Del II: Opfølgning af børn**************
Inklusionskriterier:
- Børn, der var prænatalt udsat for kræftbehandling. Der bedes om informeret samtykke fra forældrene.
Ekskluderingskriterier:
- Mentalt handicappet eller væsentligt ændret mental status, der ville forhindre forståelse og afgivelse af informeret samtykke
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
Studiegruppe
Kræft i graviditeten - alle diagnoser og behandlinger Børn født af mødre, der er diagnosticeret med kræft under graviditeten
|
Kontrolgruppe
Børn fra den brede befolkning
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Opfølgning af de mødre, der får konstateret kræft under graviditeten
Tidsramme: forventet
|
behandling under graviditet, obstetrisk udfald, moderens overlevelse
|
forventet
|
Opfølgning af de børn, der er prænatalt udsat for kemoterapi eller strålebehandling
Tidsramme: forventet
|
neurologiske og kardiologiske resultater
|
forventet
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Amant Frederic, MD PhD, KULeuven, Belgium
Publikationer og nyttige links
Generelle publikationer
- 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. doi: 10.1111/j.1525-1438.2006.00223.x.
- 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. doi: 10.1200/JCO.2006.06.1382. No abstract available.
- 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.
- 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.
- de Haan J, Verheecke M, Amant F. Management of ovarian cysts and cancer in pregnancy. Facts Views Vis Obgyn. 2015;7(1):25-31.
- 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.
- 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. No abstract available.
- 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. No abstract available.
- 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.
- Van Calsteren K, Amant F. Cancer during pregnancy. Acta Obstet Gynecol Scand. 2014 May;93(5):443-6. doi: 10.1111/aogs.12380.
- 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. Erratum In: Int J Gynecol Cancer. 2014 May;24(4):819.
- Vandenbriele C, Dierickx D, Amant F, Delforge M. The treatment of hematologic malignancies in pregnancy. Facts Views Vis Obgyn. 2010;2(2):74-87. No abstract available.
- Deckers S, Amant F. Breast cancer in pregnancy: a literature review. Facts Views Vis Obgyn. 2009;1(2):130-41.
- 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, 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, 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. No abstract available.
- 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.
- Loibl S, Han SN, Amant F. Being Pregnant and Diagnosed with Breast Cancer. Breast Care (Basel). 2012 Jun;7(3):204-209. doi: 10.1159/000339674. Epub 2012 Jun 27.
- Amant F. Safety of chemotherapy in pregnancy. Clin Adv Hematol Oncol. 2012 Apr;10(4):258-9. No abstract available.
- Verheecke M, Hermans E, Tuyaerts S, Souche E, Van Bree R, Verbist G, Everaert T, Cortes-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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. No abstract available.
- 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, 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.
- 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.
- 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.
- 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.
- 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.
- Van Calsteren K, Heyns L, De Smet F, Van Eycken L, Gziri MM, Van Gemert W, Halaska M, Vergote I, Ottevanger N, Amant F. Cancer during pregnancy: an analysis of 215 patients emphasizing the obstetrical and the neonatal outcomes. J Clin Oncol. 2010 Feb 1;28(4):683-9. doi: 10.1200/JCO.2009.23.2801. Epub 2009 Oct 19.
- Amant F, Van Calsteren K, Halaska MJ, Gziri MM, Hui W, Lagae L, Willemsen MA, Kapusta L, Van Calster B, Wouters H, Heyns L, Han SN, Tomek V, Mertens L, Ottevanger PB. Long-term cognitive and cardiac outcomes after prenatal exposure to chemotherapy in children aged 18 months or older: an observational study. Lancet Oncol. 2012 Mar;13(3):256-64. doi: 10.1016/S1470-2045(11)70363-1. Epub 2012 Feb 10.
- Gziri MM, Debieve F, DE Catte L, Mertens L, Barrea C, VAN Calsteren K, Han SN, Heyns L, Amant F. Chemotherapy during pregnancy: effect of anthracyclines on fetal and maternal cardiac function. Acta Obstet Gynecol Scand. 2012 Dec;91(12):1465-8. doi: 10.1111/j.1600-0412.2012.01524.x. Epub 2012 Nov 1.
- Loibl S, Han SN, von Minckwitz G, Bontenbal M, Ring A, Giermek J, Fehm T, Van Calsteren K, Linn SC, Schlehe B, Gziri MM, Westenend PJ, Muller V, Heyns L, Rack B, Van Calster B, Harbeck N, Lenhard M, Halaska MJ, Kaufmann M, Nekljudova V, Amant F. Treatment of breast cancer during pregnancy: an observational study. Lancet Oncol. 2012 Sep;13(9):887-96. doi: 10.1016/S1470-2045(12)70261-9. Epub 2012 Aug 16.
- Gziri MM, Amant F, Debieve F, Van Calsteren K, De Catte L, Mertens L. Effects of chemotherapy during pregnancy on the maternal and fetal heart. Prenat Diagn. 2012 Jul;32(7):614-9. doi: 10.1002/pd.3847. Epub 2012 Apr 17.
- Mhallem Gziri M, Han SN, Van Calsteren K, Heyns L, Delaere P, Nuyts S, Van den Heuvel F, Cheron AC, Fossion E, Van den Weyngaert D, Lok C, Amant F. Tongue cancers during pregnancy: Case reports and review of literature. Head Neck. 2013 Apr;35(4):E102-8. doi: 10.1002/hed.21924. Epub 2011 Oct 19.
- Gziri MM, Hui W, Amant F, Van Calsteren K, Ottevanger N, Kapusta L, Mertens L. Myocardial function in children after fetal chemotherapy exposure. A tissue Doppler and myocardial deformation imaging study. Eur J Pediatr. 2013 Feb;172(2):163-70. doi: 10.1007/s00431-012-1849-7. Epub 2012 Oct 5.
- Boussios S, Han SN, Fruscio R, Halaska MJ, Ottevanger PB, Peccatori FA, Koubkova L, Pavlidis N, Amant F. Lung cancer in pregnancy: report of nine cases from an international collaborative study. Lung Cancer. 2013 Dec;82(3):499-505. doi: 10.1016/j.lungcan.2013.09.002. Epub 2013 Sep 12.
- Amant F, von Minckwitz G, Han SN, Bontenbal M, Ring AE, Giermek J, Wildiers H, Fehm T, Linn SC, Schlehe B, Neven P, Westenend PJ, Muller V, Van Calsteren K, Rack B, Nekljudova V, Harbeck N, Untch M, Witteveen PO, Schwedler K, Thomssen C, Van Calster B, Loibl S. Prognosis of women with primary breast cancer diagnosed during pregnancy: results from an international collaborative study. J Clin Oncol. 2013 Jul 10;31(20):2532-9. doi: 10.1200/JCO.2012.45.6335. Epub 2013 Apr 22.
- Verheecke M, Halaska MJ, Lok CA, Ottevanger PB, Fruscio R, Dahl-Steffensen K, Kolawa W, Gziri MM, Han SN, Van Calsteren K, Van den Heuvel F, De Vleeschouwer S, Clement PM, Menten J, Amant F; ESGO Task Force 'Cancer in Pregnancy'. Primary brain tumours, meningiomas and brain metastases in pregnancy: report on 27 cases and review of literature. Eur J Cancer. 2014 May;50(8):1462-71. doi: 10.1016/j.ejca.2014.02.018. Epub 2014 Mar 14.
- Vandenbroucke T, Van Calsteren K, Amant F. Pediatric Outcome after Maternal Cancer Diagnosed during Pregnancy. N Engl J Med. 2016 Feb 18;374(7):693. doi: 10.1056/NEJMc1515462. No abstract available.
- Amant F, Vandenbroucke T, Verheecke M, Fumagalli M, Halaska MJ, Boere I, Han S, Gziri MM, Peccatori F, Rob L, Lok C, Witteveen P, Voigt JU, Naulaers G, Vallaeys L, Van den Heuvel F, Lagae L, Mertens L, Claes L, Van Calsteren K; International Network on Cancer, Infertility, and Pregnancy (INCIP). Pediatric Outcome after Maternal Cancer Diagnosed during Pregnancy. N Engl J Med. 2015 Nov 5;373(19):1824-34. doi: 10.1056/NEJMoa1508913. Epub 2015 Sep 28.
- Loibl S, Schmidt A, Gentilini O, Kaufman B, Kuhl C, Denkert C, von Minckwitz G, Parokonnaya A, Stensheim H, Thomssen C, van Calsteren K, Poortmans P, Berveiller P, Markert UR, Amant F. Breast Cancer Diagnosed During Pregnancy: Adapting Recent Advances in Breast Cancer Care for Pregnant Patients. JAMA Oncol. 2015 Nov;1(8):1145-53. doi: 10.1001/jamaoncol.2015.2413. Erratum In: JAMA Oncol. 2015 Nov;1(8):1172.
- Vandenbroucke T, Amant F. Development of children born to mothers with cancer during pregnancy: comparing in utero chemotherapy-exposed children with nonexposed controls. Am J Obstet Gynecol. 2015 Jun;212(6):830-1. doi: 10.1016/j.ajog.2015.01.035. Epub 2015 Jan 28. No abstract available.
- Vandenbroucke T, Verheecke M, Van Calsteren K, Han S, Claes L, Amant F. Fetal outcome after prenatal exposure to chemotherapy and mechanisms of teratogenicity compared to alcohol and smoking. Expert Opin Drug Saf. 2014 Dec;13(12):1653-65. doi: 10.1517/14740338.2014.965677. Epub 2014 Nov 10.
- van Hasselt JGC, van Calsteren K, Heyns L, Han S, Mhallem Gziri M, Schellens JHM, Beijnen JH, Huitema ADR, Amant F. Optimizing anticancer drug treatment in pregnant cancer patients: pharmacokinetic analysis of gestation-induced changes for doxorubicin, epirubicin, docetaxel and paclitaxel. Ann Oncol. 2014 Oct;25(10):2059-2065. doi: 10.1093/annonc/mdu140. Epub 2014 Apr 8.
- Dekrem J, Van Calsteren K, Amant F. Effects of fetal exposure to maternal chemotherapy. Paediatr Drugs. 2013 Oct;15(5):329-34. doi: 10.1007/s40272-013-0040-6.
- Gziri MM, Pokreisz P, De Vos R, Verbeken E, Debieve F, Mertens L, Janssens SP, Amant F. Fetal rat hearts do not display acute cardiotoxicity in response to maternal Doxorubicin treatment. J Pharmacol Exp Ther. 2013 Sep;346(3):362-9. doi: 10.1124/jpet.113.205419. Epub 2013 Jun 21.
- de Haan J, Verheecke M, Van Calsteren K, Van Calster B, Shmakov RG, Mhallem Gziri M, Halaska MJ, Fruscio R, Lok CAR, Boere IA, Zola P, Ottevanger PB, de Groot CJM, Peccatori FA, Dahl Steffensen K, Cardonick EH, Polushkina E, Rob L, Ceppi L, Sukhikh GT, Han SN, Amant F; International Network on Cancer and Infertility Pregnancy (INCIP). Oncological management and obstetric and neonatal outcomes for women diagnosed with cancer during pregnancy: a 20-year international cohort study of 1170 patients. Lancet Oncol. 2018 Mar;19(3):337-346. doi: 10.1016/S1470-2045(18)30059-7. Epub 2018 Jan 26. Erratum In: Lancet Oncol. 2021 Sep;22(9):e389.
- de Haan J, van Thienen JV, Casaer M, Hannivoort RA, Van Calsteren K, van Tuyl M, van Gerwen MM, Debeer A, Amant F, Painter RC. Severe Adverse Reaction to Vemurafenib in a Pregnant Woman with Metastatic Melanoma. Case Rep Oncol. 2018 Feb 15;11(1):119-124. doi: 10.1159/000487128. eCollection 2018 Jan-Apr.
- Boucek J, de Haan J, Halaska MJ, Plzak J, Van Calsteren K, de Groot CJM, Dahl Steffensen K, Fruscio R, Massolt ET, Klaritsch P, Zola P, Amant F; International Network on Cancer, Infertility, and Pregnancy. Maternal and obstetrical outcome in 35 cases of well-differentiated thyroid carcinoma during pregnancy. Laryngoscope. 2018 Jun;128(6):1493-1500. doi: 10.1002/lary.26936. Epub 2017 Oct 8.
- de Haan J, Lok CA, de Groot CJ, Crijns MB, Van Calsteren K, Dahl Steffensen K, Halaska MJ, Altintas S, Boere IA, Fruscio R, Kolawa W, Witteveen PO, Amant F; International Network on Cancer, Infertility and Pregnancy (INCIP). Melanoma during pregnancy: a report of 60 pregnancies complicated by melanoma. Melanoma Res. 2017 Jun;27(3):218-223. doi: 10.1097/CMR.0000000000000327.
- 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. Erratum In: Placenta. 2018 Sep;69:117.
- 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.
- 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.
- 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.
- 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. Erratum In: Psychooncology. 2018 Oct;27(10):2521.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- cancer in pregnancy
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .