ID

20811

Beschreibung

Multicentric Study, Three Randomized Arms (R−CVP vs R−CHOP vs R−FM),for Patients With Stage II−IV Follicular Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00774826

Link

https://clinicaltrials.gov/show/NCT00774826

Stichworte

Versionen (1)
  1. 20.03.17 20.03.17 -
Hochgeladen am

20. März 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Follicular Lymphoma NCT00774826

Englisch

Eligibility Follicular Lymphoma NCT00774826

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histological diagnosis of b cell follicular lymphoma
Beschreibung

Lymphoma, Follicular

Datentyp

boolean

Alias
UMLS CUI [1]
C0024301
2. ecog performance status 0−2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
3. age range 18−75
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
4. ann arbor stage: ii−iv
Beschreibung

Ann Arbor lymphoma staging system

Datentyp

boolean

Alias
UMLS CUI [1]
C0432516
5. assessment of pathology with diagnostics biopsy
Beschreibung

Biopsy

Datentyp

boolean

Alias
UMLS CUI [1]
C0005558
6. presence of one of these criteria:
Beschreibung

criteria Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1265611
b sistemic symptoms b
Beschreibung

B-Symptoms Systemic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1706867
UMLS CUI [1,2]
C0205373
extranodale pathology
Beschreibung

Extranodal Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1517068
cytopenia
Beschreibung

Cytopenia

Datentyp

boolean

Alias
UMLS CUI [1]
C0010828
splenomegaly
Beschreibung

Splenomegaly

Datentyp

boolean

Alias
UMLS CUI [1]
C0038002
leukemia
Beschreibung

leukemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0023418
serous effusion
Beschreibung

Serous effusion

Datentyp

boolean

Alias
UMLS CUI [1]
C0302149
ves > 20 mm/h
Beschreibung

Vitamin E Succinate

Datentyp

boolean

Alias
UMLS CUI [1]
C0078375
ldh > normal value
Beschreibung

Increased serum lactate dehydrogenase (LDH)

Datentyp

boolean

Alias
UMLS CUI [1]
C1848823
nodale or extranodal mass > 7 cm
Beschreibung

Nodal mass size | Mass Extranodal size

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0746921
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C3273930
UMLS CUI [2,2]
C1517067
UMLS CUI [2,3]
C0456389
3 or more nodal sites > 3 cm
Beschreibung

Site of lymph node Size Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1302572
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C1265611
adenopatic syndrome
Beschreibung

Adenopathy Syndrome

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0497156
UMLS CUI [1,2]
C0039082
7. lvef > 50%
Beschreibung

Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
8. normal hepatic (bilirubin < 1.5 mg/dl) and renal functionality (creatinin < 2 mg/dl). if there is a lymphoma it's allow values of bilirubin > 1.5 mg/dl and of creatinin > 2mg/dl
Beschreibung

Liver function | Serum total bilirubin measurement | Renal function | Creatinine measurement, serum | Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0232804
UMLS CUI [4]
C0201976
UMLS CUI [5]
C0024299
9. no previous treatment for follicolar lymphoma unless rt−if
Beschreibung

Therapeutic procedure Follicular Lymphoma | Involved-Field Radiation Therapy Follicular Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0024301
UMLS CUI [2,1]
C3826993
UMLS CUI [2,2]
C0024301
10. lifetime > 6 mounth
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
11. absence of hbsag, hcv e hiv
Beschreibung

Hepatitis B Surface Antigens Absent | Hepatitis C virus Absent | Hepatitis B Virus Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019168
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0220847
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0019169
UMLS CUI [3,2]
C0332197
12. negative coombs test
Beschreibung

Coombs test negative

Datentyp

boolean

Alias
UMLS CUI [1]
C0877268
13. negative pregnant test
Beschreibung

Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1]
C0427780
14. cotracceptive method during the treatment and the follow three months
Beschreibung

Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
15. formal written consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
16. ability to follow the patients after the treatment for follow up
Beschreibung

Clinical Study Follow-up Patient Available

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0470187
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. histological diagnosis of all type of lymphoma unless follicularlymphoma, cd20 lymphoma, stage iiib of follicular lymphoma and high degree lymphoma
Beschreibung

Lymphoma Type All | Lymphoma, Follicular | Lymphoma CD20 | Follicular Lymphoma Ann Arbor lymphoma staging system | Lymphoma Degree High

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0444868
UMLS CUI [2]
C0024301
UMLS CUI [3,1]
C0024299
UMLS CUI [3,2]
C0054946
UMLS CUI [4,1]
C0024301
UMLS CUI [4,2]
C0432516
UMLS CUI [5,1]
C0024299
UMLS CUI [5,2]
C0441889
UMLS CUI [5,3]
C0205250
2. stage i of ann arbor scale
Beschreibung

Ann Arbor lymphoma staging system

Datentyp

boolean

Alias
UMLS CUI [1]
C0432516
3. central nervous system involvement
Beschreibung

Central Nervous System Involvement

Datentyp

boolean

Alias
UMLS CUI [1]
C4050309
4. hiv, hbv or hcv positivity
Beschreibung

HIV Seropositivity | Hepatitis B virus test positive | Hepatitis C virus test positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C2748184
UMLS CUI [3]
C2748185
5. cardiac pathology
Beschreibung

Heart Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
6. positive coombs test
Beschreibung

Coombs test positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0239113
7. previous chemotherapeutic treatment
Beschreibung

Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
8. hypersensitivity to antibodyes or other murine proteins
Beschreibung

Hypersensitivity Antibodies | Hypersensitivity murine protein

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0003241
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1699668
9. previous cancer pathology unless in situ cervix and epithelial carcinomas
Beschreibung

Malignant Neoplasms | Carcinoma in situ of uterine cervix | Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0851140
UMLS CUI [3]
C0007097
10. other type of infections
Beschreibung

Communicable Disease Type

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0332307
11. pregnant and nursing woman
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Follicular Lymphoma NCT00774826

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Lymphoma, Follicular
Item
1. histological diagnosis of b cell follicular lymphoma
boolean
C0024301 (UMLS CUI [1])
ECOG performance status
Item
2. ecog performance status 0−2
boolean
C1520224 (UMLS CUI [1])
Age
Item
3. age range 18−75
boolean
C0001779 (UMLS CUI [1])
Ann Arbor lymphoma staging system
Item
4. ann arbor stage: ii−iv
boolean
C0432516 (UMLS CUI [1])
Biopsy
Item
5. assessment of pathology with diagnostics biopsy
boolean
C0005558 (UMLS CUI [1])
criteria Quantity
Item
6. presence of one of these criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
B-Symptoms Systemic
Item
b sistemic symptoms b
boolean
C1706867 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Extranodal Disease
Item
extranodale pathology
boolean
C1517068 (UMLS CUI [1])
Cytopenia
Item
cytopenia
boolean
C0010828 (UMLS CUI [1])
Splenomegaly
Item
splenomegaly
boolean
C0038002 (UMLS CUI [1])
leukemia
Item
leukemia
boolean
C0023418 (UMLS CUI [1])
Serous effusion
Item
serous effusion
boolean
C0302149 (UMLS CUI [1])
Vitamin E Succinate
Item
ves > 20 mm/h
boolean
C0078375 (UMLS CUI [1])
Increased serum lactate dehydrogenase (LDH)
Item
ldh > normal value
boolean
C1848823 (UMLS CUI [1])
Nodal mass size | Mass Extranodal size
Item
nodale or extranodal mass > 7 cm
boolean
C0746921 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C3273930 (UMLS CUI [2,1])
C1517067 (UMLS CUI [2,2])
C0456389 (UMLS CUI [2,3])
Site of lymph node Size Quantity
Item
3 or more nodal sites > 3 cm
boolean
C1302572 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Adenopathy Syndrome
Item
adenopatic syndrome
boolean
C0497156 (UMLS CUI [1,1])
C0039082 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
7. lvef > 50%
boolean
C0428772 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Renal function | Creatinine measurement, serum | Lymphoma
Item
8. normal hepatic (bilirubin < 1.5 mg/dl) and renal functionality (creatinin < 2 mg/dl). if there is a lymphoma it's allow values of bilirubin > 1.5 mg/dl and of creatinin > 2mg/dl
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0024299 (UMLS CUI [5])
Therapeutic procedure Follicular Lymphoma | Involved-Field Radiation Therapy Follicular Lymphoma
Item
9. no previous treatment for follicolar lymphoma unless rt−if
boolean
C0087111 (UMLS CUI [1,1])
C0024301 (UMLS CUI [1,2])
C3826993 (UMLS CUI [2,1])
C0024301 (UMLS CUI [2,2])
Life Expectancy
Item
10. lifetime > 6 mounth
boolean
C0023671 (UMLS CUI [1])
Hepatitis B Surface Antigens Absent | Hepatitis C virus Absent | Hepatitis B Virus Absent
Item
11. absence of hbsag, hcv e hiv
boolean
C0019168 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0220847 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0019169 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Coombs test negative
Item
12. negative coombs test
boolean
C0877268 (UMLS CUI [1])
Pregnancy test negative
Item
13. negative pregnant test
boolean
C0427780 (UMLS CUI [1])
Contraceptive methods
Item
14. cotracceptive method during the treatment and the follow three months
boolean
C0700589 (UMLS CUI [1])
Informed Consent
Item
15. formal written consent
boolean
C0021430 (UMLS CUI [1])
Clinical Study Follow-up Patient Available
Item
16. ability to follow the patients after the treatment for follow up
boolean
C3274571 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Lymphoma Type All | Lymphoma, Follicular | Lymphoma CD20 | Follicular Lymphoma Ann Arbor lymphoma staging system | Lymphoma Degree High
Item
1. histological diagnosis of all type of lymphoma unless follicularlymphoma, cd20 lymphoma, stage iiib of follicular lymphoma and high degree lymphoma
boolean
C0024299 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0444868 (UMLS CUI [1,3])
C0024301 (UMLS CUI [2])
C0024299 (UMLS CUI [3,1])
C0054946 (UMLS CUI [3,2])
C0024301 (UMLS CUI [4,1])
C0432516 (UMLS CUI [4,2])
C0024299 (UMLS CUI [5,1])
C0441889 (UMLS CUI [5,2])
C0205250 (UMLS CUI [5,3])
Ann Arbor lymphoma staging system
Item
2. stage i of ann arbor scale
boolean
C0432516 (UMLS CUI [1])
Central Nervous System Involvement
Item
3. central nervous system involvement
boolean
C4050309 (UMLS CUI [1])
HIV Seropositivity | Hepatitis B virus test positive | Hepatitis C virus test positive
Item
4. hiv, hbv or hcv positivity
boolean
C0019699 (UMLS CUI [1])
C2748184 (UMLS CUI [2])
C2748185 (UMLS CUI [3])
Heart Disease
Item
5. cardiac pathology
boolean
C0018799 (UMLS CUI [1])
Coombs test positive
Item
6. positive coombs test
boolean
C0239113 (UMLS CUI [1])
Chemotherapy
Item
7. previous chemotherapeutic treatment
boolean
C0392920 (UMLS CUI [1])
Hypersensitivity Antibodies | Hypersensitivity murine protein
Item
8. hypersensitivity to antibodyes or other murine proteins
boolean
C0020517 (UMLS CUI [1,1])
C0003241 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1699668 (UMLS CUI [2,2])
Malignant Neoplasms | Carcinoma in situ of uterine cervix | Carcinoma
Item
9. previous cancer pathology unless in situ cervix and epithelial carcinomas
boolean
C0006826 (UMLS CUI [1])
C0851140 (UMLS CUI [2])
C0007097 (UMLS CUI [3])
Communicable Disease Type
Item
10. other type of infections
boolean
C0009450 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
11. pregnant and nursing woman
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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