ID

21433

Description

Adenovirus Encoding Rat HER-2 in Patients With Metastatic Breast Cancer (AdHER2.1); ODM derived from: https://clinicaltrials.gov/show/NCT00307229

Link

https://clinicaltrials.gov/show/NCT00307229

Keywords

Versions (1)
  1. 4/21/17 4/21/17 -
Uploaded on

April 21, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00307229

English

Eligibility Metastatic Breast Cancer NCT00307229

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. metastatic or locally recurrent breast cancer,
Description

Metastatic or locally recurrent breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0278488
UMLS CUI [2,1]
C2986682
UMLS CUI [2,2]
C0678222
2. 18 years of age or older,
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. her-2/neu positive (3+ by immunohistochemistry or fish +),
Description

her-2/neu status

Data type

boolean

Alias
UMLS CUI [1]
C1512413
4. one of the following
Description

Inclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C1512693
1. currently receiving hormonal therapy or are candidates for such or,
Description

Hormone therapy

Data type

boolean

Alias
UMLS CUI [1]
C0279025
2. being considered for trastuzumab or,
Description

Trastuzumab

Data type

boolean

Alias
UMLS CUI [1]
C0338204
3. their cancer has progressed on trastuzumab
Description

Cancer progression on trastuzumab

Data type

boolean

Alias
UMLS CUI [1,1]
C1947901
UMLS CUI [1,2]
C0338204
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant or lactating women.
Description

Gynaecological status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. prior or concurrent malignancies except treated basal cell or squamous carcinoma of the skin or in situ cancer of the cervix or any other cancer treated and presumed cured more than five years prior to study entry.
Description

Prior malignancy

Data type

boolean

Alias
UMLS CUI [1]
C2735088
3. currently receiving chemotherapy, immunotherapy, adenoviral gene therapy or biological cancer therapy. [note: concurrent hormonal therapy (tamoxifen,aromatase inhibitors, or megace) is permitted.].
Description

Currently receiving chemotherapy, immunotherapy, adenoviral gene therapy or biological cancer therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0392920
UMLS CUI [2,1]
C0521116
UMLS CUI [2,2]
C0021083
UMLS CUI [3,1]
C0521116
UMLS CUI [3,2]
C0860404
UMLS CUI [4,1]
C0521116
UMLS CUI [4,2]
C1531518
4. treatment with trastuzumab within 4 weeks prior to first dose of vaccine therapy.
Description

Date of trastuzumab treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0338204
5. hemoglobin < 80 g/l or granulocytes < 1.5 x 109 /l or lymphocytes < 1.0 x 109 /l or platelets < 100 x 109 /l.
Description

Hemoglobin measurement, granulocyte count, lymphocyte count, platelets

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0857490
UMLS CUI [3]
C0200635
UMLS CUI [4]
C0005821
6. baseline liver enzymes (ast or alt) greater than 3 times upper limit of normal or greater than 5 times upper limit of normal if liver metastases present and/or bilirubin greater than 50 mmol.
Description

Liver enzymes, liver metastases

Data type

boolean

Alias
UMLS CUI [1]
C1287351
UMLS CUI [2]
C0494165
UMLS CUI [3]
C1278039
7. cd4 cells < 0.5 x 109 /l
Description

CD4 cell count

Data type

boolean

Alias
UMLS CUI [1]
C0519835
8. patients with documented brain metastases.
Description

Brain metastases

Data type

boolean

Alias
UMLS CUI [1]
C0220650
9. patients with any acute illness that would interfere with vaccination
Description

Acute Illness affecting vaccination

Data type

boolean

Alias
UMLS CUI [1,1]
C4061114
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0042196
10. any patients requiring concurrent immunosuppressive therapy (e.g. corticosteroids).
Description

Immunosuppression

Data type

boolean

Alias
UMLS CUI [1]
C0021079
11. eastern cooperative oncology group (ecog) performance status of > 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
12. patients with a life expectancy of less than 6 months.
Description

Life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
13. geographic inaccessibility which would preclude follow-up. patients registered on the trial must be treated and followed at the jewish general hospital.
Description

Residency

Data type

boolean

Alias
UMLS CUI [1]
C0035182
14. failure to give written informed consent.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
15. baseline left ventricular ejection fraction (lvef) < 55% by echocardiography or muga scan.
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
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Similar models

Eligibility Metastatic Breast Cancer NCT00307229

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Metastatic or locally recurrent breast cancer
Item
1. metastatic or locally recurrent breast cancer,
boolean
C0278488 (UMLS CUI [1])
C2986682 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Age
Item
2. 18 years of age or older,
boolean
C0001779 (UMLS CUI [1])
her-2/neu status
Item
3. her-2/neu positive (3+ by immunohistochemistry or fish +),
boolean
C1512413 (UMLS CUI [1])
Inclusion Criteria
Item
4. one of the following
boolean
C1512693 (UMLS CUI [1])
Hormone therapy
Item
1. currently receiving hormonal therapy or are candidates for such or,
boolean
C0279025 (UMLS CUI [1])
Trastuzumab
Item
2. being considered for trastuzumab or,
boolean
C0338204 (UMLS CUI [1])
Cancer progression on trastuzumab
Item
3. their cancer has progressed on trastuzumab
boolean
C1947901 (UMLS CUI [1,1])
C0338204 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Gynaecological status
Item
1. pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Prior malignancy
Item
2. prior or concurrent malignancies except treated basal cell or squamous carcinoma of the skin or in situ cancer of the cervix or any other cancer treated and presumed cured more than five years prior to study entry.
boolean
C2735088 (UMLS CUI [1])
Currently receiving chemotherapy, immunotherapy, adenoviral gene therapy or biological cancer therapy
Item
3. currently receiving chemotherapy, immunotherapy, adenoviral gene therapy or biological cancer therapy. [note: concurrent hormonal therapy (tamoxifen,aromatase inhibitors, or megace) is permitted.].
boolean
C0521116 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0521116 (UMLS CUI [2,1])
C0021083 (UMLS CUI [2,2])
C0521116 (UMLS CUI [3,1])
C0860404 (UMLS CUI [3,2])
C0521116 (UMLS CUI [4,1])
C1531518 (UMLS CUI [4,2])
Date of trastuzumab treatment
Item
4. treatment with trastuzumab within 4 weeks prior to first dose of vaccine therapy.
boolean
C0011008 (UMLS CUI [1,1])
C0338204 (UMLS CUI [1,2])
Hemoglobin measurement, granulocyte count, lymphocyte count, platelets
Item
5. hemoglobin < 80 g/l or granulocytes < 1.5 x 109 /l or lymphocytes < 1.0 x 109 /l or platelets < 100 x 109 /l.
boolean
C0518015 (UMLS CUI [1])
C0857490 (UMLS CUI [2])
C0200635 (UMLS CUI [3])
C0005821 (UMLS CUI [4])
Liver enzymes, liver metastases
Item
6. baseline liver enzymes (ast or alt) greater than 3 times upper limit of normal or greater than 5 times upper limit of normal if liver metastases present and/or bilirubin greater than 50 mmol.
boolean
C1287351 (UMLS CUI [1])
C0494165 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
CD4 cell count
Item
7. cd4 cells < 0.5 x 109 /l
boolean
C0519835 (UMLS CUI [1])
Brain metastases
Item
8. patients with documented brain metastases.
boolean
C0220650 (UMLS CUI [1])
Acute Illness affecting vaccination
Item
9. patients with any acute illness that would interfere with vaccination
boolean
C4061114 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Immunosuppression
Item
10. any patients requiring concurrent immunosuppressive therapy (e.g. corticosteroids).
boolean
C0021079 (UMLS CUI [1])
ECOG performance status
Item
11. eastern cooperative oncology group (ecog) performance status of > 2.
boolean
C1520224 (UMLS CUI [1])
Life expectancy
Item
12. patients with a life expectancy of less than 6 months.
boolean
C0023671 (UMLS CUI [1])
Residency
Item
13. geographic inaccessibility which would preclude follow-up. patients registered on the trial must be treated and followed at the jewish general hospital.
boolean
C0035182 (UMLS CUI [1])
Informed consent
Item
14. failure to give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Left ventricular ejection fraction
Item
15. baseline left ventricular ejection fraction (lvef) < 55% by echocardiography or muga scan.
boolean
C0428772 (UMLS CUI [1])
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