ID

12918

Beskrivning

Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype; ODM derived from: https://clinicaltrials.gov/show/NCT00001572

Länk

https://clinicaltrials.gov/show/NCT00001572

Nyckelord

Versioner (1)
  1. 2016-01-06 2016-01-06 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

6 januari 2016

DOI

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Licens

Creative Commons BY-NC 3.0
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Eligibility B Cell Lymphoma NCT00001572

Engelsk

Eligibility B Cell Lymphoma NCT00001572

1 Formulär  
Criteria
Beskrivning

Criteria

sex distribution: male and female.
Beskrivning

sex

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
age: patients must be greater than or equal to 18 years old.
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
patients must meet all of the following eligibility criteria:
Beskrivning

eligibility criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C1512693
tissue diagnosis of: follicular small cleaved cell or follicular mixed lymphoma with surface igm, iga, or igg phenotype with a monoclonal heavy and light chain. pathology slides must be submitted to the nih pathology department for review.
Beskrivning

lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0024299
stage iii or iv lymphoma.
Beskrivning

tumor stage

Datatyp

boolean

Alias
UMLS CUI [1]
C1300072
a single peripheral lymph node of at least 2x2 to 3x3 cm size and accessible for biopsy/harvest.
Beskrivning

lymph node

Datatyp

boolean

Alias
UMLS CUI [1]
C0024204
karnofsky status greater than or equal to 70%.
Beskrivning

karnofsky status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
life expectancy of greater than 1 year.
Beskrivning

life expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
serum creatinine less than or equal to 1.5 mg/dl unless felt to be secondary to lymphoma.
Beskrivning

serum creatinine

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
bilirubin less than or equal to 1.5 mg/dl unless felt to be secondary to lymphoma or gilbert's disease. sgot/sgpt less than or equal to 3.5 x upper limit of normal.
Beskrivning

Bilirubin, SGOT/SGPT

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
ability to give informed consent. ability to return to clinic for adequate follow-up for the period that the protocol requires.
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
the presence of any exclusion criteria (listed below) will prohibit entry onto study:
Beskrivning

the presence of any exclusion criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
prior total body irradiation.
Beskrivning

irradiation

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
presence of antibodies to hiv or hepatitis b surface antigen or other active infectious process.
Beskrivning

infectious process

Datatyp

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0019163
pregnant or lactation. fertile men and women must plan to use an effective contraception. a beta-hcg level will be obtained in women of child-bearing potential.
Beskrivning

pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0700589
patients with previous or concomitant malignancy, regardless of site, except curatively treated squamous or basal cell carcinoma of the skin, or effectively treated carcinoma in situ of the cervix.
Beskrivning

malignancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
patient unwilling to give informed consent.
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
any medical or psychiatric condition that in the opinion of the protocol chairman would compromise the patient's ability to tolerate this treatment.
Beskrivning

any medical or psychiatric condition that in the opinion of the protocol chairman would compromise the patient's ability to tolerate this treatment.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
patients with cns lymphoma (current or previously treated) will not be eligible.
Beskrivning

cns lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0280803
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Similar models

Eligibility B Cell Lymphoma NCT00001572

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
sex
Item
sex distribution: male and female.
boolean
C0079399 (UMLS CUI [1])
age
Item
age: patients must be greater than or equal to 18 years old.
boolean
C0001779 (UMLS CUI [1])
eligibility criteria
Item
patients must meet all of the following eligibility criteria:
boolean
C1512693 (UMLS CUI [1])
lymphoma
Item
tissue diagnosis of: follicular small cleaved cell or follicular mixed lymphoma with surface igm, iga, or igg phenotype with a monoclonal heavy and light chain. pathology slides must be submitted to the nih pathology department for review.
boolean
C0024299 (UMLS CUI [1])
tumor stage
Item
stage iii or iv lymphoma.
boolean
C1300072 (UMLS CUI [1])
lymph node
Item
a single peripheral lymph node of at least 2x2 to 3x3 cm size and accessible for biopsy/harvest.
boolean
C0024204 (UMLS CUI [1])
karnofsky status
Item
karnofsky status greater than or equal to 70%.
boolean
C0206065 (UMLS CUI [1])
life expectancy
Item
life expectancy of greater than 1 year.
boolean
C0023671 (UMLS CUI [1])
serum creatinine
Item
serum creatinine less than or equal to 1.5 mg/dl unless felt to be secondary to lymphoma.
boolean
C0201976 (UMLS CUI [1])
Bilirubin, SGOT/SGPT
Item
bilirubin less than or equal to 1.5 mg/dl unless felt to be secondary to lymphoma or gilbert's disease. sgot/sgpt less than or equal to 3.5 x upper limit of normal.
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
informed consent
Item
ability to give informed consent. ability to return to clinic for adequate follow-up for the period that the protocol requires.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
the presence of any exclusion criteria
Item
the presence of any exclusion criteria (listed below) will prohibit entry onto study:
boolean
C0680251 (UMLS CUI [1])
irradiation
Item
prior total body irradiation.
boolean
C1522449 (UMLS CUI [1])
infectious process
Item
presence of antibodies to hiv or hepatitis b surface antigen or other active infectious process.
boolean
C0019682 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
pregnancy
Item
pregnant or lactation. fertile men and women must plan to use an effective contraception. a beta-hcg level will be obtained in women of child-bearing potential.
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
malignancy
Item
patients with previous or concomitant malignancy, regardless of site, except curatively treated squamous or basal cell carcinoma of the skin, or effectively treated carcinoma in situ of the cervix.
boolean
C0006826 (UMLS CUI [1])
informed consent
Item
patient unwilling to give informed consent.
boolean
C0021430 (UMLS CUI [1])
any medical or psychiatric condition that in the opinion of the protocol chairman would compromise the patient's ability to tolerate this treatment.
Item
any medical or psychiatric condition that in the opinion of the protocol chairman would compromise the patient's ability to tolerate this treatment.
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
cns lymphoma
Item
patients with cns lymphoma (current or previously treated) will not be eligible.
boolean
C0280803 (UMLS CUI [1])
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