Studieoverzicht - 2003-04 Pregnancy
| Number | 2003-04 Pregnancy | ||||
| Nickname | Pregnancy | ||||
| Status | Follow up | Date: 03-08-2017 | |||
| Inclusion closed | 03-08-2017 | ||||
| Other study number(s) | GBG 29, BIG 2-03 | ||||
| Participating parties/groups | GBG, BIG | ||||
| Full title | Prospective and Retrospective Register Study of the German Breast Group (GBG) for Diagnosis and Treatment of Breast Cancer in Pregnancy. | ||||
| Phase and type | Observational | ||||
| Age | ≥ 18 | ||||
| Menopausal status | Premenopausal | ||||
| Indication | Not applicable | ||||
| Subindication | Any HER2, any HR | ||||
| Target sample size | 1500 | ||||
| Actual accrual | 773 (NL 119) | Date: 01-03-2017 | |||
| Estimated study completion date | |||||
| CCMO approval | Not applicable | Date: | Nr: | ||
| EudraCT nr. | nvt | ||||
| Trial Register | nvt | ||||
| METC approval | Not applicable | Date: 25-08-2005 | METC: Erasmus Medisch Centrum Rotterdam | Nr: MEC2005-152, statement of no objection | |
| Amendments | Yes | Date: 24-02-2014 | |||
| KWF-CKS approval | Not applicable | Date: | Nr: | ||
| News item | |||||
| Website | http://www.bigagainstbreastcancer.org/what-we-do/clinical-trials/big-2-03-breast-cancer-pregnancy | ||||
| Sponsor | GBG | ||||
| Principal Investigator(s) | C. van Zuylen | |||
| Study manager | A.E. van Leeuwen-Stok, N.H. Dijkstra | |||
| Central datamanagement and randomization | BOOG Study Center Postbus 9236 1006 AE Amsterdam tel 088-2346730 fax 088-2346739 email info@boogstudycenter.nl |
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| Monitoring | Not applicable | |||
| Local datamanagement | ||||
| Funding | ||||
| Extra | ||||
Design:
Registration study
Objectives:
Endpoints:
Primary endpoint:
Outcome child 4 weeks after partus
Secondary endpoints:
Maternal outcome of pregnancy; Stage of and biological characteristics of breast cancer; Breast cancer therapy (treatment, response to chemotherapy, type of surgery);Sensitivity and specifity of diagnostic procedures (palpation, US, mammogram);Outcome of the newborn after 5 years of therapy; Outcome of breast cancer 5 years after diagnosis
Main eligibility criteria:
Breast cancer during pregnancy (histologically confirmed) Informed consent when prospective registration
Documents (public):
Hier kunt u meer informatie vinden over deze studie en deelnemende ziekenhuizen
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