Eligibility Follicular Lymphoma NCT00774826

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StudyEvent: Eligibility
1. Eligibility Follicular Lymphoma NCT00774826

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Inclusion Criteria

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])

Exclusion Criteria

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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Eligibility Follicular Lymphoma NCT00774826