ID

18011

Description

Phase II Trial of Combined Modality Treatment in Primary Central Nervous System Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00210314

Link

https://clinicaltrials.gov/show/NCT00210314

Keywords

Versions (1)
  1. 10/13/16 10/13/16 -
Uploaded on

October 13, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Lymphoma, B Cell NCT00210314

English

Eligibility Lymphoma, B Cell NCT00210314

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histological or cytological diagnosis of non-hodgkin's lymphoma.
Description

Lymphoma, Non-Hodgkin

Data type

boolean

Alias
UMLS CUI [1]
C0024305
2. diagnostic sample obtained by stereotactic or surgical biopsy, csf cytology examination or vitrectomy.
Description

Sample obtained Stereotactic Biopsy | Sample obtained Surgical biopsy | Sample obtained Cerebrospinal Fluid Cytology procedure | Sample obtained Vitrectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C1277697
UMLS CUI [1,2]
C1711202
UMLS CUI [2,1]
C1277697
UMLS CUI [2,2]
C0370003
UMLS CUI [2,3]
C0565118
UMLS CUI [3,1]
C1277697
UMLS CUI [3,2]
C0007806
UMLS CUI [3,3]
C1305671
UMLS CUI [4,1]
C1277697
UMLS CUI [4,2]
C0042903
3. disease exclusively localized into the central nervous system, cranial nerves or eyes.
Description

Disease Localized Central Nervous System | Disease Localized Cranial Nerves | Disease Localized Eyes

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392752
UMLS CUI [1,3]
C3714787
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0392752
UMLS CUI [2,3]
C0010268
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0392752
UMLS CUI [3,3]
C0015392
4. untreated patients (patients treated with steroids alone are eligible).
Description

Patients untreated | Steroids alone

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C0205171
5. at least one measurable lesion.
Description

Measurable lesion Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
6. age 18 - 75 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
7. ecog performance status < 3
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
8. hbsag-negative and ab anti-hcv-negative serologic status.
Description

Hepatitis B surface antigen negative | Hepatitis C Antibodies Serologic Negative

Data type

boolean

Alias
UMLS CUI [1]
C0919711
UMLS CUI [2,1]
C0166049
UMLS CUI [2,2]
C0205473
UMLS CUI [2,3]
C1513916
9. no known hiv disease or immunodeficiency.
Description

HIV | Immunologic Deficiency Syndromes

Data type

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0021051
10. adequate bone marrow (plt > 100000 mm3, hb ≥ 9 g/dl, anc ≥ 2.000 mm3), renal (creatinine clearance ≥ 60 ml/min), cardiac (vef ≥ 50%), and hepatic function (total serum bilirubin < 3 mg/dl, ast/alt and ggt < 2 per upper normal limit value).
Description

Bone Marrow function | Platelet Count measurement | Hemoglobin | Absolute neutrophil count | Renal function | Creatinine clearance measurement | Cardiac function | Ventricular Ejection Fraction | Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Gamma glutamyl transferase measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0019046
UMLS CUI [4]
C0948762
UMLS CUI [5]
C0232804
UMLS CUI [6]
C0373595
UMLS CUI [7]
C0232164
UMLS CUI [8]
C0042508
UMLS CUI [9]
C0232741
UMLS CUI [10]
C1278039
UMLS CUI [11]
C0201899
UMLS CUI [12]
C0201836
UMLS CUI [13]
C0202035
11. no previous or concurrent malignancies with the exception of surgically cured cervical intraepithelial neoplasia type 1 (cin1) or localized non-melanomatous skin cancer and of other cancers without evidence of disease since at least 5 years (patients with a previous lymphoma diagnosis will be excluded).
Description

Malignant Neoplasms | Cervical intraepithelial neoplasia grade 1 Cure of disease surgical | Skin carcinoma Localized | Lymphoma Previous

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0349458
UMLS CUI [2,2]
C0679252
UMLS CUI [2,3]
C0543467
UMLS CUI [3,1]
C0699893
UMLS CUI [3,2]
C0392752
UMLS CUI [4,1]
C0024299
UMLS CUI [4,2]
C0205156
12. absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Description

Condition Affecting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0525058
13. non-pregnant and non-lactating status for female patients. adequate contraceptive measures during study participation for sexually active patients of childbearing potential.
Description

Pregnancy | Breast Feeding | Childbearing Potential Sex Behavior Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0036864
UMLS CUI [3,3]
C0700589
14. no concurrent treatment with other experimental drugs.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
15. informed consent signed by the patient before registration
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Back to the top of the page

Similar models

Eligibility Lymphoma, B Cell NCT00210314

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Lymphoma, Non-Hodgkin
Item
1. histological or cytological diagnosis of non-hodgkin's lymphoma.
boolean
C0024305 (UMLS CUI [1])
Sample obtained Stereotactic Biopsy | Sample obtained Surgical biopsy | Sample obtained Cerebrospinal Fluid Cytology procedure | Sample obtained Vitrectomy
Item
2. diagnostic sample obtained by stereotactic or surgical biopsy, csf cytology examination or vitrectomy.
boolean
C1277697 (UMLS CUI [1,1])
C1711202 (UMLS CUI [1,2])
C1277697 (UMLS CUI [2,1])
C0370003 (UMLS CUI [2,2])
C0565118 (UMLS CUI [2,3])
C1277697 (UMLS CUI [3,1])
C0007806 (UMLS CUI [3,2])
C1305671 (UMLS CUI [3,3])
C1277697 (UMLS CUI [4,1])
C0042903 (UMLS CUI [4,2])
Disease Localized Central Nervous System | Disease Localized Cranial Nerves | Disease Localized Eyes
Item
3. disease exclusively localized into the central nervous system, cranial nerves or eyes.
boolean
C0012634 (UMLS CUI [1,1])
C0392752 (UMLS CUI [1,2])
C3714787 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0392752 (UMLS CUI [2,2])
C0010268 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0392752 (UMLS CUI [3,2])
C0015392 (UMLS CUI [3,3])
Patients untreated | Steroids alone
Item
4. untreated patients (patients treated with steroids alone are eligible).
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0038317 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
Measurable lesion Quantity
Item
5. at least one measurable lesion.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Age
Item
6. age 18 - 75 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
7. ecog performance status < 3
boolean
C1520224 (UMLS CUI [1])
Hepatitis B surface antigen negative | Hepatitis C Antibodies Serologic Negative
Item
8. hbsag-negative and ab anti-hcv-negative serologic status.
boolean
C0919711 (UMLS CUI [1])
C0166049 (UMLS CUI [2,1])
C0205473 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
HIV | Immunologic Deficiency Syndromes
Item
9. no known hiv disease or immunodeficiency.
boolean
C0019682 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
Bone Marrow function | Platelet Count measurement | Hemoglobin | Absolute neutrophil count | Renal function | Creatinine clearance measurement | Cardiac function | Ventricular Ejection Fraction | Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Gamma glutamyl transferase measurement
Item
10. adequate bone marrow (plt > 100000 mm3, hb ≥ 9 g/dl, anc ≥ 2.000 mm3), renal (creatinine clearance ≥ 60 ml/min), cardiac (vef ≥ 50%), and hepatic function (total serum bilirubin < 3 mg/dl, ast/alt and ggt < 2 per upper normal limit value).
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0032181 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0373595 (UMLS CUI [6])
C0232164 (UMLS CUI [7])
C0042508 (UMLS CUI [8])
C0232741 (UMLS CUI [9])
C1278039 (UMLS CUI [10])
C0201899 (UMLS CUI [11])
C0201836 (UMLS CUI [12])
C0202035 (UMLS CUI [13])
Malignant Neoplasms | Cervical intraepithelial neoplasia grade 1 Cure of disease surgical | Skin carcinoma Localized | Lymphoma Previous
Item
11. no previous or concurrent malignancies with the exception of surgically cured cervical intraepithelial neoplasia type 1 (cin1) or localized non-melanomatous skin cancer and of other cancers without evidence of disease since at least 5 years (patients with a previous lymphoma diagnosis will be excluded).
boolean
C0006826 (UMLS CUI [1])
C0349458 (UMLS CUI [2,1])
C0679252 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C0699893 (UMLS CUI [3,1])
C0392752 (UMLS CUI [3,2])
C0024299 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
Condition Affecting Protocol Compliance
Item
12. absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
boolean
C0348080 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Childbearing Potential Sex Behavior Contraceptive methods
Item
13. non-pregnant and non-lactating status for female patients. adequate contraceptive measures during study participation for sexually active patients of childbearing potential.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0036864 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
Investigational New Drugs
Item
14. no concurrent treatment with other experimental drugs.
boolean
C0013230 (UMLS CUI [1])
Informed Consent
Item
15. informed consent signed by the patient before registration
boolean
C0021430 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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