ID

39592

Beskrivning

Phase II Cancer Vaccine Trial for Patients With Follicular Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01926639

Länk

https://clinicaltrials.gov/show/NCT01926639

Nyckelord

Versioner (1)
  1. 2020-02-01 2020-02-01 -
Rättsinnehavare

See clinicaltrials.gov

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1 februari 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Follicular Lymphoma NCT01926639

Engelsk

Eligibility Follicular Lymphoma NCT01926639

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 18 years and older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. histologically confirmed (by who classification) untreated and relapsed indolent non-hodgkin's b-cell lymphoma of low-grade follicular, marginal zone, lymphoplasmocytic or small lymphocytic subtypes.
Beskrivning

Recurrent Indolent Adult Non-Hodgkin Lymphoma Untreated WHO classification | Follicular Lymphoma low grade | Marginal Zone B-Cell Lymphoma | Lymphoplasmacytic lymphoma | Small Lymphocytic Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677723
UMLS CUI [1,2]
C0332155
UMLS CUI [1,3]
C4267671
UMLS CUI [2,1]
C0024301
UMLS CUI [2,2]
C1282907
UMLS CUI [3]
C1367654
UMLS CUI [4]
C0024419
UMLS CUI [5]
C0855095
3. stage iii/iv
Beskrivning

Ann Arbor lymphoma staging system

Datatyp

boolean

Alias
UMLS CUI [1]
C0432516
4. adequate bone marrow function (leukocyte count>2,0, neutrophil count>1.0, platelets>50)
Beskrivning

Bone Marrow function | White Blood Cell Count procedure | Neutrophil count | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0200633
UMLS CUI [4]
C0032181
5. two or more separate lymph nodes > 1,5 cm available for biopsy or treatment.
Beskrivning

Lymph nodes Quantity Biopsy | Lymph nodes Quantity Therapeutic procedure | Size of lymph node

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0005558
UMLS CUI [2,1]
C0024204
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0087111
UMLS CUI [3]
C1285847
6. measurable disease present other than biopsy site and injection site(s).
Beskrivning

Measurable Disease | Exception Biopsy Site | Exception Injection Site

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0005558
UMLS CUI [2,3]
C1515974
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1533685
UMLS CUI [3,3]
C1515974
7. required wash-out period after previous treatment: chemotherapy - 8 weeks, radiotherapy - 4 weeks, rituximab - 12 weeks
Beskrivning

Washout Period Required | Status post Prior Therapy | Chemotherapy | Therapeutic radiology procedure | rituximab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1710661
UMLS CUI [1,2]
C1514873
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1514463
UMLS CUI [3]
C0392920
UMLS CUI [4]
C1522449
UMLS CUI [5]
C0393022
8. who status 0-1
Beskrivning

WHO performance status scale

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
9. life expectancy of more than 6 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
10. written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
11. able to comply with the treatment protocol -
Beskrivning

Treatment Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C4319828
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with progressive lymphoma in need of systemic therapy or standard dose irradiation.
Beskrivning

Lymphoma Progressive | Patient need for Systemic therapy | Patient need for Irradiation Standard Dose

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0205329
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C1515119
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C1522449
UMLS CUI [3,3]
C1442989
UMLS CUI [3,4]
C0178602
2. chronic bacterial, viral or fungal infection
Beskrivning

Bacterial Infection chronic | Virus Disease chronic | Mycoses chronic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0042769
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0026946
UMLS CUI [3,2]
C0205191
3. pre-existing autoimmune or antibody mediated disease including: systemic lupus, erythematosus, rheumatoid arthritis, multiple sclerosis, sjogren's syndrome, autoimmune thrombocytopenia, but excluding controlled thyroid disease, or the presence of autoantibodies without clinical autoimmune disease.
Beskrivning

Autoimmune Disease Pre-existing | Disease Due to Antibodies | Lupus Erythematosus, Systemic | Rheumatoid Arthritis | Multiple Sclerosis | Sjogren's Syndrome | Autoimmune thrombocytopenia | Exception Thyroid Disease Controlled | Exception Autoantibodies Without Autoimmune Diseases

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0003241
UMLS CUI [3]
C0024141
UMLS CUI [4]
C0003873
UMLS CUI [5]
C0026769
UMLS CUI [6]
C1527336
UMLS CUI [7]
C0242584
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0040128
UMLS CUI [8,3]
C2911690
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0004358
UMLS CUI [9,3]
C0332288
UMLS CUI [9,4]
C0004364
4. known history of hiv
Beskrivning

HIV Infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
5. central nervous system involvement of lymphoma
Beskrivning

Central Nervous System Involvement Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0024299
6. current anticoagulant therapy which can not safely be paused during treatment injections (asa < 325 mg/day allowed)
Beskrivning

Anticoagulant therapy Discontinuation Unsuccessful | Aspirin U/day allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0150457
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1272705
UMLS CUI [2,1]
C0004057
UMLS CUI [2,2]
C0456683
UMLS CUI [2,3]
C0683607
7. pregnancy -
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Follicular Lymphoma NCT01926639

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age 18 years and older
boolean
C0001779 (UMLS CUI [1])
Recurrent Indolent Adult Non-Hodgkin Lymphoma Untreated WHO classification | Follicular Lymphoma low grade | Marginal Zone B-Cell Lymphoma | Lymphoplasmacytic lymphoma | Small Lymphocytic Lymphoma
Item
2. histologically confirmed (by who classification) untreated and relapsed indolent non-hodgkin's b-cell lymphoma of low-grade follicular, marginal zone, lymphoplasmocytic or small lymphocytic subtypes.
boolean
C0677723 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C4267671 (UMLS CUI [1,3])
C0024301 (UMLS CUI [2,1])
C1282907 (UMLS CUI [2,2])
C1367654 (UMLS CUI [3])
C0024419 (UMLS CUI [4])
C0855095 (UMLS CUI [5])
Ann Arbor lymphoma staging system
Item
3. stage iii/iv
boolean
C0432516 (UMLS CUI [1])
Bone Marrow function | White Blood Cell Count procedure | Neutrophil count | Platelet Count measurement
Item
4. adequate bone marrow function (leukocyte count>2,0, neutrophil count>1.0, platelets>50)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0023508 (UMLS CUI [2])
C0200633 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Lymph nodes Quantity Biopsy | Lymph nodes Quantity Therapeutic procedure | Size of lymph node
Item
5. two or more separate lymph nodes > 1,5 cm available for biopsy or treatment.
boolean
C0024204 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
C0024204 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1285847 (UMLS CUI [3])
Measurable Disease | Exception Biopsy Site | Exception Injection Site
Item
6. measurable disease present other than biopsy site and injection site(s).
boolean
C1513041 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C1515974 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1533685 (UMLS CUI [3,2])
C1515974 (UMLS CUI [3,3])
Washout Period Required | Status post Prior Therapy | Chemotherapy | Therapeutic radiology procedure | rituximab
Item
7. required wash-out period after previous treatment: chemotherapy - 8 weeks, radiotherapy - 4 weeks, rituximab - 12 weeks
boolean
C1710661 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0393022 (UMLS CUI [5])
WHO performance status scale
Item
8. who status 0-1
boolean
C1298650 (UMLS CUI [1])
Life Expectancy
Item
9. life expectancy of more than 6 months
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
10. written informed consent
boolean
C0021430 (UMLS CUI [1])
Treatment Compliance
Item
11. able to comply with the treatment protocol -
boolean
C4319828 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Lymphoma Progressive | Patient need for Systemic therapy | Patient need for Irradiation Standard Dose
Item
1. patients with progressive lymphoma in need of systemic therapy or standard dose irradiation.
boolean
C0024299 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C1515119 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C1442989 (UMLS CUI [3,3])
C0178602 (UMLS CUI [3,4])
Bacterial Infection chronic | Virus Disease chronic | Mycoses chronic
Item
2. chronic bacterial, viral or fungal infection
boolean
C0004623 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0042769 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0026946 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
Autoimmune Disease Pre-existing | Disease Due to Antibodies | Lupus Erythematosus, Systemic | Rheumatoid Arthritis | Multiple Sclerosis | Sjogren's Syndrome | Autoimmune thrombocytopenia | Exception Thyroid Disease Controlled | Exception Autoantibodies Without Autoimmune Diseases
Item
3. pre-existing autoimmune or antibody mediated disease including: systemic lupus, erythematosus, rheumatoid arthritis, multiple sclerosis, sjogren's syndrome, autoimmune thrombocytopenia, but excluding controlled thyroid disease, or the presence of autoantibodies without clinical autoimmune disease.
boolean
C0004364 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0003241 (UMLS CUI [2,3])
C0024141 (UMLS CUI [3])
C0003873 (UMLS CUI [4])
C0026769 (UMLS CUI [5])
C1527336 (UMLS CUI [6])
C0242584 (UMLS CUI [7])
C1705847 (UMLS CUI [8,1])
C0040128 (UMLS CUI [8,2])
C2911690 (UMLS CUI [8,3])
C1705847 (UMLS CUI [9,1])
C0004358 (UMLS CUI [9,2])
C0332288 (UMLS CUI [9,3])
C0004364 (UMLS CUI [9,4])
HIV Infection
Item
4. known history of hiv
boolean
C0019693 (UMLS CUI [1])
Central Nervous System Involvement Lymphoma
Item
5. central nervous system involvement of lymphoma
boolean
C4050309 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
Anticoagulant therapy Discontinuation Unsuccessful | Aspirin U/day allowed
Item
6. current anticoagulant therapy which can not safely be paused during treatment injections (asa < 325 mg/day allowed)
boolean
C0150457 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
C0004057 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Pregnancy
Item
7. pregnancy -
boolean
C0032961 (UMLS CUI [1])
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