Primary testicular lymphoma | Diffuse Large B-Cell Lymphoma WHO tumor classification
Item
1. patients with primary testicular lymphoma at diagnosis. histological subtype included into the study is only diffuse large b cell lymphoma (attachment 2: who classification of lymphoma).
boolean
C0349644 (UMLS CUI [1])
C0079744 (UMLS CUI [2,1])
C1301142 (UMLS CUI [2,2])
Orchiectomy mandatory
Item
2. orchiectomy is mandatory, before enrolment of the patient into the study.
boolean
C0029189 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Orchiectomy Recently
Item
3. orchiectomy should be performed within 2 months before study entry.
boolean
C0029189 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Age
Item
4. age 18-80
boolean
C0001779 (UMLS CUI [1])
Patients untreated
Item
5. untreated patients
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Ann Arbor lymphoma staging system | Testicular Involvement Bilateral
Item
6. ann arbor stage ie and iie. bilateral testicular involvement at presentation will not be considered stage iv. these patients may be included into the study and the final ann arbor stage (i or ii) will be determined by the extent of nodal disease.
boolean
C0432516 (UMLS CUI [1])
C4053942 (UMLS CUI [2,1])
C0238767 (UMLS CUI [2,2])
Measurable Disease 2-Dimensional | Evaluable Disease | Excision Disease All
Item
7. bidimensionally measurable or evaluable disease. patients who have had all disease removed by surgery are eligible.
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C1516986 (UMLS CUI [2])
C0728940 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0444868 (UMLS CUI [3,3])
Hematologic function | Absolute neutrophil count | Platelet Count measurement
Item
8. adequate haematological counts: anc > 1.0 x 109/l and plts count > 75 x 109/l
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Cardiac ejection fraction MUGA scan | Cardiac ejection fraction Echocardiography
Item
9. cardiac ejection fraction ≥ 45% by muga scan or echocardiography
boolean
C0232174 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Neuropathy | Exception Peripheral Neuropathy | Non-Neoplastic Central Nervous System Disorder
Item
10. non peripheral neuropathy or any active non-neoplastic cns disease.
boolean
C0442874 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0031117 (UMLS CUI [2,2])
C1335000 (UMLS CUI [3])
Life threatening illness Absent | Life threatening illness Excludes Chemotherapy
Item
11. no other major life-threatening illnesses that may preclude chemotherapy
boolean
C3846017 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3846017 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
Serum conjugated bilirubin measurement
Item
12. conjugated bilirubin ≤ 2 x uln.
boolean
C1278038 (UMLS CUI [1])
Alkaline phosphatase measurement | Transaminase Assay
Item
13. alkaline phosphatase and transaminases ≤ 2 x uln.
boolean
C0201850 (UMLS CUI [1])
C0919834 (UMLS CUI [2])
Creatinine clearance measurement
Item
14. creatinine clearances ≥ 45 ml/min.
boolean
C0373595 (UMLS CUI [1])
HIV negative
Item
15. hiv negativity
boolean
C0481430 (UMLS CUI [1])
Hepatitis B Virus Negative | HBcAb Positive | Hepatitis B surface antigen negative | Hepatitis B Virus Surface Antibody Positive | Hepatitis B Virus Surface Antibody Negative | Hbv DNA Test Negative
Item
16. hbv negativity or patients with hbvcab +, hbsag -, hbs ab+/- with hbv-dna negative
boolean
C0019169 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C3702086 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0919711 (UMLS CUI [3])
C0369334 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C0369334 (UMLS CUI [5,1])
C1513916 (UMLS CUI [5,2])
C1256114 (UMLS CUI [6,1])
C1513916 (UMLS CUI [6,2])
Hepatitis C virus Negative | Exception Absence Signs Chronic Hepatitis
Item
17. hcv negativity with the exception of patients with no signs of active chronic hepatitis histologically confirmed
boolean
C0220847 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0311392 (UMLS CUI [2,3])
C0019189 (UMLS CUI [2,4])
Life Expectancy
Item
18. life expectancy > 6 months.
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
19. performance status < 2 according to ecog scale.
boolean
C1520224 (UMLS CUI [1])
Mental disorders Absent
Item
20. no psychiatric illness that precludes understanding concepts of the trial or signing informed consent
boolean
C0004936 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Informed Consent
Item
21. written informed consent
boolean
C0021430 (UMLS CUI [1])
Hypersensitivity Rituximab | Intolerance to Rituximab | Hypersensitivity Suspected Rituximab | Intolerance Suspected Rituximab
Item
1. has known or suspected hypersensitivity or intolerance to rituximab
boolean
C0020517 (UMLS CUI [1,1])
C0393022 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0393022 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0393022 (UMLS CUI [3,3])
C1744706 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0393022 (UMLS CUI [4,3])
Hepatic Insufficiency | Renal Insufficiency | Heart Diseases | Vascular Diseases | Lung diseases | Gastrointestinal Diseases | Endocrine System Diseases | Nervous system disorder | Rheumatism | Hematological Disease | Mental disorders | Metabolic Diseases
Item
2. history of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
boolean
C1306571 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
C0042373 (UMLS CUI [4])
C0024115 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0014130 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0035435 (UMLS CUI [9])
C0018939 (UMLS CUI [10])
C0004936 (UMLS CUI [11])
C0025517 (UMLS CUI [12])
Diabetic - poor control | Antidiabetics Dose Stable
Item
3. uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug)
boolean
C0421258 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe | Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Disorder of pericardium | Cardiac amyloidosis
Item
4. uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, new york heart association (nyha) class iii or iv heart failure (attachment 5, nyha classification of cardiac disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0018801 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
C0002962 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0265122 (UMLS CUI [6])
C0268407 (UMLS CUI [7])
Hypotension
Item
5. history of clinically relevant hypotension
boolean
C0020649 (UMLS CUI [1])
Central Nervous System Involvement | Meninges Involvement with Lymphoma | Brain Involvement with Lymphoma
Item
6. cns involvement (meningeal and/or brain involvement by lymphoma)
boolean
C4050309 (UMLS CUI [1])
C0025285 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0024299 (UMLS CUI [2,3])
C0006104 (UMLS CUI [3,1])
C1314939 (UMLS CUI [3,2])
C0024299 (UMLS CUI [3,3])
Malignant Neoplasms Evolving | Exception Skin carcinoma Localized
Item
7. evolving malignancy within 3 years with the exception of localized non-melanomatous skin cancer
boolean
C0006826 (UMLS CUI [1,1])
C0332253 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C0392752 (UMLS CUI [2,3])
HIV Seropositivity
Item
8. hiv positivity
boolean
C0019699 (UMLS CUI [1])
Hepatitis B virus test positive | Exception HBcAb Positive | Exception Hepatitis B surface antigen negative | Exception Hepatitis B Virus Surface Antibody Positive | Exception Hepatitis B Virus Surface Antibody Negative | Exception Hbv DNA Test Negative
Item
9. hbv positivity with the exception of patients with hbvcab +, hbsag -, hbs ab+/- with hbv-dna negative
boolean
C2748184 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C3702086 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0919711 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0369334 (UMLS CUI [4,2])
C1514241 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0369334 (UMLS CUI [5,2])
C1513916 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C1256114 (UMLS CUI [6,2])
C1513916 (UMLS CUI [6,3])
Hepatitis C Virus Positive | Exception Absence Signs Chronic Hepatitis
Item
10. hcv positivity with the exception of patients with no signs of active chronic hepatitis histologically confirmed
boolean
C4330254 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0311392 (UMLS CUI [2,3])
C0019189 (UMLS CUI [2,4])
Opportunistic Infections
Item
11. active opportunistic infection
boolean
C0029118 (UMLS CUI [1])
Therapeutic radiology procedure Extensive | Systemic Chemotherapy | Cancer treatment
Item
12. receipt of extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy
boolean
C1522449 (UMLS CUI [1,1])
C0205231 (UMLS CUI [1,2])
C1883256 (UMLS CUI [2])
C0920425 (UMLS CUI [3])
Exposure to Rituximab
Item
13. exposure to rituximab prior study entry
boolean
C0332157 (UMLS CUI [1,1])
C0393022 (UMLS CUI [1,2])
Investigational New Drugs | Investigational Medical Device
Item
14. have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study.
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
Comorbidity Study Subject Participation Status Excluded | Comorbidity compromises Informed Consent | Mental condition Study Subject Participation Status Excluded | Mental condition compromises Informed Consent
Item
15. any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C0021430 (UMLS CUI [4,3])