ID

18011

Beschreibung

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

Stichworte

Versionen (1)
  1. 13.10.16 13.10.16 -
Hochgeladen am

13. Oktober 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Lymphoma, B Cell NCT00210314

Englisch

Eligibility Lymphoma, B Cell NCT00210314

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Lymphoma, Non-Hodgkin

Datentyp

boolean

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

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

Datentyp

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.
Beschreibung

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

Datentyp

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).
Beschreibung

Patients untreated | Steroids alone

Datentyp

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.
Beschreibung

Measurable lesion Quantity

Datentyp

boolean

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

Age

Datentyp

boolean

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

ECOG performance status

Datentyp

boolean

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

Hepatitis B surface antigen negative | Hepatitis C Antibodies Serologic Negative

Datentyp

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.
Beschreibung

HIV | Immunologic Deficiency Syndromes

Datentyp

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).
Beschreibung

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

Datentyp

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).
Beschreibung

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

Datentyp

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.
Beschreibung

Condition Affecting Protocol Compliance

Datentyp

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.
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Sex Behavior Contraceptive methods

Datentyp

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.
Beschreibung

Investigational New Drugs

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
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Ähnliche Modelle

Eligibility Lymphoma, B Cell NCT00210314

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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