ID

30225

Beschrijving

Combination Chemotherapy in Treating Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01005758

Link

https://clinicaltrials.gov/show/NCT01005758

Trefwoorden

Versies (1)
  1. 22-05-18 22-05-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

22 mei 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Leukemia NCT01005758

Engels

Eligibility Leukemia NCT01005758

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01005758
Criteria
Beschrijving

Criteria

diagnosis of acute lymphoblastic leukemia (all)
Beschrijving

Acute lymphocytic leukemia

Datatype

boolean

Alias
UMLS CUI [1]
C0023449
no known mature b-cell all*, defined by the presence of surface immunoglobulin, l3 morphology, t(8;14)(q24;q32), t(8;22), or t(2;8)
Beschrijving

Exclusion Burkitt Leukemia | Receptors, Antigen, B-Cell | t(8;14)(q24;q32) | Other Coding

Datatype

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0006413
UMLS CUI [2]
C0034789
UMLS CUI [3]
C1515792
UMLS CUI [4]
C4331809
UMLS CUI [5]
C3846158
patients with t-cell surface markers and t(8;14)(q24;q11) are eligible note:
Beschrijving

T-cell surface markers | t(8;14)(q24;q11)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0039194
UMLS CUI [1,2]
C0699040
UMLS CUI [1,3]
C0005516
UMLS CUI [2]
C1515791
*patients with mature b-cell all will be removed from the study as soon as that diagnosis is made.
Beschrijving

Exclusion Burkitt Leukemia

Datatype

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0006413
no secondary all (i.e., all arising after another malignancy)
Beschrijving

Exclusion Acute lymphocytic leukemia Secondary

Datatype

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0023449
UMLS CUI [1,3]
C0175668
patient characteristics:
Beschrijving

Client Characteristics

Datatype

boolean

Alias
UMLS CUI [1]
C0815172
not pregnant or nursing
Beschrijving

Pregnancy Absent | Breast Feeding Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
negative pregnancy test
Beschrijving

Pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0427780
fertile patients must use effective contraception
Beschrijving

Fertility Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
no known hiv positivity (hiv testing is not required)
Beschrijving

HIV Seropositivity Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019699
UMLS CUI [1,2]
C0332197
no comorbid medical condition that would, in the investigator's opinion, make participation in this study and adherence to the study guidelines a compromise to the study objectives
Beschrijving

Exclusion | Comorbidity compromises Study Subject Participation Status | Comorbidity compromises Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C0525058
no active psychiatric or mental illness that would make giving informed consent or careful clinical follow-up unlikely
Beschrijving

Exclusion | Mental disorders Informed Consent Unlikely | Mental disorders Follow-up Unlikely

Datatype

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0021430
UMLS CUI [2,3]
C0750558
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C3274571
UMLS CUI [3,3]
C0750558
prior concurrent therapy:
Beschrijving

Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0087111
no prior anti-leukemic therapy except ≤ 1 week of steroids, emergent radiotherapy to the mediastinum, hydroxyurea, or emergent leukapheresis
Beschrijving

Exclusion | Therapeutic procedure Leukemia Related | Exception Steroids | Exception Radiotherapy to mediastinum Emergency | Exception Hydroxyurea | Exception Leukapheresis Emergency

Datatype

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0023418
UMLS CUI [2,3]
C0439849
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0038317
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C4049191
UMLS CUI [4,3]
C0013956
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0020402
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0023416
UMLS CUI [6,3]
C0013956
patients who have received steroids within the past 7 days are eligible but will not receive steroid prophase therapy on study
Beschrijving

Steroids Recently

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C0332185
no concurrent chronic steroids or anti-metabolite therapy
Beschrijving

Exclusion Criteria | Steroids chronic | Antimetabolites chronic

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0003376
UMLS CUI [3,2]
C0205191
Terug naar het begin van de pagina

Similar models

Eligibility Leukemia NCT01005758

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01005758
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Acute lymphocytic leukemia
Item
diagnosis of acute lymphoblastic leukemia (all)
boolean
C0023449 (UMLS CUI [1])
Exclusion Burkitt Leukemia | Receptors, Antigen, B-Cell | t(8;14)(q24;q32) | Other Coding
Item
no known mature b-cell all*, defined by the presence of surface immunoglobulin, l3 morphology, t(8;14)(q24;q32), t(8;22), or t(2;8)
boolean
C2828389 (UMLS CUI [1,1])
C0006413 (UMLS CUI [1,2])
C0034789 (UMLS CUI [2])
C1515792 (UMLS CUI [3])
C4331809 (UMLS CUI [4])
C3846158 (UMLS CUI [5])
T-cell surface markers | t(8;14)(q24;q11)
Item
patients with t-cell surface markers and t(8;14)(q24;q11) are eligible note:
boolean
C0039194 (UMLS CUI [1,1])
C0699040 (UMLS CUI [1,2])
C0005516 (UMLS CUI [1,3])
C1515791 (UMLS CUI [2])
Exclusion Burkitt Leukemia
Item
*patients with mature b-cell all will be removed from the study as soon as that diagnosis is made.
boolean
C2828389 (UMLS CUI [1,1])
C0006413 (UMLS CUI [1,2])
Exclusion Acute lymphocytic leukemia Secondary
Item
no secondary all (i.e., all arising after another malignancy)
boolean
C2828389 (UMLS CUI [1,1])
C0023449 (UMLS CUI [1,2])
C0175668 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
HIV Seropositivity Absent
Item
no known hiv positivity (hiv testing is not required)
boolean
C0019699 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Exclusion | Comorbidity compromises Study Subject Participation Status | Comorbidity compromises Protocol Compliance
Item
no comorbid medical condition that would, in the investigator's opinion, make participation in this study and adherence to the study guidelines a compromise to the study objectives
boolean
C2828389 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
Exclusion | Mental disorders Informed Consent Unlikely | Mental disorders Follow-up Unlikely
Item
no active psychiatric or mental illness that would make giving informed consent or careful clinical follow-up unlikely
boolean
C2828389 (UMLS CUI [1])
C0004936 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
C0750558 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C3274571 (UMLS CUI [3,2])
C0750558 (UMLS CUI [3,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Exclusion | Therapeutic procedure Leukemia Related | Exception Steroids | Exception Radiotherapy to mediastinum Emergency | Exception Hydroxyurea | Exception Leukapheresis Emergency
Item
no prior anti-leukemic therapy except ≤ 1 week of steroids, emergent radiotherapy to the mediastinum, hydroxyurea, or emergent leukapheresis
boolean
C2828389 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0023418 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0038317 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C4049191 (UMLS CUI [4,2])
C0013956 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0020402 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0023416 (UMLS CUI [6,2])
C0013956 (UMLS CUI [6,3])
Steroids Recently
Item
patients who have received steroids within the past 7 days are eligible but will not receive steroid prophase therapy on study
boolean
C0038317 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Exclusion Criteria | Steroids chronic | Antimetabolites chronic
Item
no concurrent chronic steroids or anti-metabolite therapy
boolean
C0680251 (UMLS CUI [1])
C0038317 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0003376 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial