ID

39324

Beskrivning

Oncoquest-L Vaccine in Patients With Previously Untreated Stage III or IV, Asymptomatic, Non-bulky Follicular Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02194751

Länk

https://clinicaltrials.gov/show/NCT02194751

Nyckelord

Versioner (2)
  1. 2019-12-19 2019-12-19 -
  2. 2019-12-19 2019-12-19 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

19 december 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Follicular Lymphoma NCT02194751

Engelsk

Eligibility Follicular Lymphoma NCT02194751

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. follicular lymphoma (fl) grade 1, 2, or 3a diagnosed within 12 months of study enrollment
Beskrivning

Follicular Lymphoma Grade

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0441800
2. age ≥ 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. previously untreated stage iii or iv fl
Beskrivning

Follicular Lymphoma Untreated Ann Arbor lymphoma staging system

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0332155
UMLS CUI [1,3]
C0432516
4. a single peripheral lymph node of at least 1 x 1 cm in size accessible for excisional biopsy
Beskrivning

Lymph node Peripheral Single | Size of lymph node | Lymph node Suitable Excision biopsy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0205100
UMLS CUI [1,3]
C0205171
UMLS CUI [2]
C1285847
UMLS CUI [3,1]
C0024204
UMLS CUI [3,2]
C3900053
UMLS CUI [3,3]
C0184921
5. measurable or evaluable disease after obtaining tissue for vaccine production
Beskrivning

Measurable Disease | Evaluable Disease | Availability of Tissue specimen Vaccine Production

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
UMLS CUI [3,1]
C0470187
UMLS CUI [3,2]
C1292533
UMLS CUI [3,3]
C1519894
6. performance status (ecog) of 0 or 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
7. asymptomatic disease without b symptoms or severe pruritus
Beskrivning

Asymptomatic Disease | B-Symptoms Absent | Pruritus Severe Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C2936329
UMLS CUI [2,1]
C1706867
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0033774
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0332197
8. low tumor burden as defined by the following criteria:
Beskrivning

Tumor Burden low

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1449699
UMLS CUI [1,2]
C0205251
normal lactic dehydrogenase
Beskrivning

Lactate Dehydrogenase Normal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022917
UMLS CUI [1,2]
C0205307
largest tumor mass < 7 cm
Beskrivning

Tumor Mass Largest

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3273930
UMLS CUI [1,2]
C0443228
involvement of < 3 nodal sites with a diameter ≥ 3 cm
Beskrivning

Involvement Site of lymph node Quantity | Site of lymph node Diameter

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1314939
UMLS CUI [1,2]
C1302572
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1302572
UMLS CUI [2,2]
C1301886
no clinically significant pleural effusion or ascites
Beskrivning

Pleural effusion Absent | Ascites Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032227
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0003962
UMLS CUI [2,2]
C0332197
spleen size of ≤ 16 cm by ct scan
Beskrivning

Spleen Size CT scan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0037993
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0040405
circulating tumor cells < 5.0 x 109/l
Beskrivning

Circulating Tumor Cell Count

Datatyp

boolean

Alias
UMLS CUI [1]
C3272887
no clinically significant organ compression
Beskrivning

Organ Compression Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0728907
UMLS CUI [1,3]
C0332197
9. adequate hematopoietic parameters:
Beskrivning

Parameters Hematopoietic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449381
UMLS CUI [1,2]
C0229601
absolute neutrophil count ≥ 1.5 x 109/l
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
platelet count ≥ 100 x 109/l
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin ≥ 10 g/dl
Beskrivning

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
10. serum creatinine ≤ 2 x upper limit of normal (uln)
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
11. total bilirubin ≤ 2 x uln unless considered secondary to gilbert's syndrome. aspartate aminotransferase (ast), alanine aminotransferase (alt), alkaline phosphatase ≤ 2 x uln
Beskrivning

Serum total bilirubin measurement | Exception Secondary to Gilbert Disease | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C0017551
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201850
12. fertile patients must use effective contraception during and for 12 months after completion of therapy
Beskrivning

Patients Fertile Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0015895
UMLS CUI [1,3]
C0700589
13. for fertile female patients, a negative pregnancy test result at enrollment
Beskrivning

Childbearing Potential Pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. active hiv, hepatitis b, hepatitis c or other active infectious process
Beskrivning

HIV Infection | Hepatitis B | Hepatitis C | INFECTIOUS PROCESS

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
UMLS CUI [4]
C0745283
2. pregnant or nursing women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. patients with previous history of malignancy within the past 2 years except curatively treated squamous or basal cell carcinoma of the skin or curatively treated carcinoma in situ of the cervix.
Beskrivning

Malignant Neoplasms | Exception Curative treatment Squamous cell carcinoma of skin | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0553723
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0851140
4. any medical or psychiatric condition that in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment
Beskrivning

Medical condition compromises Therapeutic procedure | Mental condition compromises Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0087111
5. concurrent treatment with immunosuppressive therapy
Beskrivning

Therapeutic immunosuppression

Datatyp

boolean

Alias
UMLS CUI [1]
C0021079
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Similar models

Eligibility Follicular Lymphoma NCT02194751

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Follicular Lymphoma Grade
Item
1. follicular lymphoma (fl) grade 1, 2, or 3a diagnosed within 12 months of study enrollment
boolean
C0024301 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Age
Item
2. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Follicular Lymphoma Untreated Ann Arbor lymphoma staging system
Item
3. previously untreated stage iii or iv fl
boolean
C0024301 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0432516 (UMLS CUI [1,3])
Lymph node Peripheral Single | Size of lymph node | Lymph node Suitable Excision biopsy
Item
4. a single peripheral lymph node of at least 1 x 1 cm in size accessible for excisional biopsy
boolean
C0024204 (UMLS CUI [1,1])
C0205100 (UMLS CUI [1,2])
C0205171 (UMLS CUI [1,3])
C1285847 (UMLS CUI [2])
C0024204 (UMLS CUI [3,1])
C3900053 (UMLS CUI [3,2])
C0184921 (UMLS CUI [3,3])
Measurable Disease | Evaluable Disease | Availability of Tissue specimen Vaccine Production
Item
5. measurable or evaluable disease after obtaining tissue for vaccine production
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
C0470187 (UMLS CUI [3,1])
C1292533 (UMLS CUI [3,2])
C1519894 (UMLS CUI [3,3])
ECOG performance status
Item
6. performance status (ecog) of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Asymptomatic Disease | B-Symptoms Absent | Pruritus Severe Absent
Item
7. asymptomatic disease without b symptoms or severe pruritus
boolean
C2936329 (UMLS CUI [1])
C1706867 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0033774 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Tumor Burden low
Item
8. low tumor burden as defined by the following criteria:
boolean
C1449699 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
Lactate Dehydrogenase Normal
Item
normal lactic dehydrogenase
boolean
C0022917 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Tumor Mass Largest
Item
largest tumor mass < 7 cm
boolean
C3273930 (UMLS CUI [1,1])
C0443228 (UMLS CUI [1,2])
Involvement Site of lymph node Quantity | Site of lymph node Diameter
Item
involvement of < 3 nodal sites with a diameter ≥ 3 cm
boolean
C1314939 (UMLS CUI [1,1])
C1302572 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1302572 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
Pleural effusion Absent | Ascites Absent
Item
no clinically significant pleural effusion or ascites
boolean
C0032227 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0003962 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Spleen Size CT scan
Item
spleen size of ≤ 16 cm by ct scan
boolean
C0037993 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
Circulating Tumor Cell Count
Item
circulating tumor cells < 5.0 x 109/l
boolean
C3272887 (UMLS CUI [1])
Organ Compression Absent
Item
no clinically significant organ compression
boolean
C0178784 (UMLS CUI [1,1])
C0728907 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Parameters Hematopoietic
Item
9. adequate hematopoietic parameters:
boolean
C0449381 (UMLS CUI [1,1])
C0229601 (UMLS CUI [1,2])
Absolute neutrophil count
Item
absolute neutrophil count ≥ 1.5 x 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥ 100 x 109/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin ≥ 10 g/dl
boolean
C0518015 (UMLS CUI [1])
Creatinine measurement, serum
Item
10. serum creatinine ≤ 2 x upper limit of normal (uln)
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement | Exception Secondary to Gilbert Disease | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
11. total bilirubin ≤ 2 x uln unless considered secondary to gilbert's syndrome. aspartate aminotransferase (ast), alanine aminotransferase (alt), alkaline phosphatase ≤ 2 x uln
boolean
C1278039 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0017551 (UMLS CUI [2,3])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201850 (UMLS CUI [5])
Patients Fertile Contraceptive methods
Item
12. fertile patients must use effective contraception during and for 12 months after completion of therapy
boolean
C0030705 (UMLS CUI [1,1])
C0015895 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Childbearing Potential Pregnancy test negative
Item
13. for fertile female patients, a negative pregnancy test result at enrollment
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
HIV Infection | Hepatitis B | Hepatitis C | INFECTIOUS PROCESS
Item
1. active hiv, hepatitis b, hepatitis c or other active infectious process
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0745283 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
2. pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignant Neoplasms | Exception Curative treatment Squamous cell carcinoma of skin | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix
Item
3. patients with previous history of malignancy within the past 2 years except curatively treated squamous or basal cell carcinoma of the skin or curatively treated carcinoma in situ of the cervix.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0553723 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0007117 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0851140 (UMLS CUI [4,3])
Medical condition compromises Therapeutic procedure | Mental condition compromises Therapeutic procedure
Item
4. any medical or psychiatric condition that in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment
boolean
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Therapeutic immunosuppression
Item
5. concurrent treatment with immunosuppressive therapy
boolean
C0021079 (UMLS CUI [1])
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