search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


MBL(Mannose binding lectine)-studie.


- candidate number12192
- NTR NumberNTR3398
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-apr-2012
- Secondary IDs2011/42 SFG
- Public TitleMBL(Mannose binding lectine)-studie.
- Scientific TitleMBL and prediction of risk on chemotherapy induced febrile neutropenia in patients with a solid tumor.
- ACRONYM
- hypothesisMBL deficiency might give rise to a higher chance of the occurence of febrile neutropenia.
- Healt Condition(s) or Problem(s) studiedChemotherapy, Solid tumors
- Inclusion criteria1. Patients commencing chemotherapy treatments for a solid tumor;
2. Written informed consent.
- Exclusion criteria1. Previous participation in the current study;
2. Patients < 18 yrs;
3. Patients not able to give informed consent;
4. Patients receiving chemotherapy in a weekly schedule or a bi-weekly dose dense schedule;
5. Patients receiving granulocyte growth factor support (G-CSF);
6. Patients receiving a treatment with an individualized risk (combination of scheme and presence of risk factors) on FN over 20% according to the EORTC guidelines;
7. Patients receiving (prophylactic) antibiotics;
8. Patients receiving concomittant radiotherapy.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2012
- planned closingdate1-mrt-2014
- Target number of participants243
- InterventionsN/A
- Primary outcomeRelation between baseline MBL and incidence of febrile neutropenia (FN).
- Secondary outcome1. MBL genotype and relation FN;
2. Changes in MBL concentration;
3. Relate severity of FN with MBL levels.
- TimepointsPrior to cycle 1 and prior to cycle 2 and during FN measurement of MBL.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES A.P. Hamberg
- CONTACT for SCIENTIFIC QUERIES A.P. Hamberg
- Sponsor/Initiator Sint Franciscus Gasthuis (SFG)
- Funding
(Source(s) of Monetary or Material Support)
Amgen, Roche
- PublicationsN/A
- Brief summaryMeasuring MBL prior to chemotherapy and at an episode of FN in patients receiving chemotherapy for a solid tumor.
- Main changes (audit trail)
- RECORD3-apr-2012 - 30-apr-2012


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl