ID

34974

Description

HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02063724

Link

https://clinicaltrials.gov/show/NCT02063724

Keywords

Versions (1)
  1. 2/6/19 2/6/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 6, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02063724

English

Eligibility Breast Cancer NCT02063724

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women over age 18 years.
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
subjects with invasive breast cancer at least stage iiia greater than or equal to n2 (4 positive nodes) or have recurrent metastatic breast cancer rendered ned by any means that are classic her-2 3+ 30%, 2+ ihc and fish positive or her-2 2+ fish negative verified by the department of pathology at the hospital of the university of pennsylvania that have completed chemotherapy and/or trastuzumab and are within 1 year from there last treatment and have no evidence of disease.
Description

Invasive carcinoma of breast TNM Breast tumor staging | BREAST CANCER METASTATIC RECURRENT | HER2 Status Immunohistochemistry | HER2 Status FISH | Chemotherapy Completed | trastuzumab

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0474926
UMLS CUI [2]
C0741681
UMLS CUI [3,1]
C1512413
UMLS CUI [3,2]
C0021044
UMLS CUI [4,1]
C1512413
UMLS CUI [4,2]
C0162789
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C0205197
UMLS CUI [6]
C0728747
patients deemed to require anti-estrogen therapy for treatment of their breast cancer can continue anti-estrogen therapy during vaccinations
Description

Antioestrogen therapy Breast Carcinoma | Vaccination

Data type

boolean

Alias
UMLS CUI [1,1]
C0854638
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C0042196
women of childbearing age with a negative pregnancy test documented prior to enrollment.
Description

Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
subjects with ecog performance status score of 0 or 1 (appendix d).
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
subjects willing to use birth control if necessary
Description

Contraceptive methods Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0600109
subjects who have voluntarily signed a written informed consent in accordance with institutional policies after its contents have been fully explained to them.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating females.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subjects with positive hiv or hepatitis c at baseline by report.
Description

HIV Seropositivity | Hepatitis C positive

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C1112419
subjects with coagulopathies, including thrombocytopenia with platelet count less than 75,000, inr greater than 1.5 and partial thromboplastin time greater than 50 sec
Description

Blood Coagulation Disorders | Thrombocytopenia | Platelet Count measurement | International Normalized Ratio | Partial thromboplastin time finding

Data type

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0040034
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0525032
UMLS CUI [5]
C1531697
subjects with major cardiac illness muga less than 50% ef.
Description

Heart Disease Major | Cardiac ejection fraction MUGA

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0521317
subjects with pre-existing medical illnesses or medications which might interfere with the study as determined by pi.
Description

Pre-existing condition Interferes with Clinical Trial | Pharmaceutical Preparations Interfere with Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0521987
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0008976
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Similar models

Eligibility Breast Cancer NCT02063724

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women over age 18 years.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Invasive carcinoma of breast TNM Breast tumor staging | BREAST CANCER METASTATIC RECURRENT | HER2 Status Immunohistochemistry | HER2 Status FISH | Chemotherapy Completed | trastuzumab
Item
subjects with invasive breast cancer at least stage iiia greater than or equal to n2 (4 positive nodes) or have recurrent metastatic breast cancer rendered ned by any means that are classic her-2 3+ 30%, 2+ ihc and fish positive or her-2 2+ fish negative verified by the department of pathology at the hospital of the university of pennsylvania that have completed chemotherapy and/or trastuzumab and are within 1 year from there last treatment and have no evidence of disease.
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0741681 (UMLS CUI [2])
C1512413 (UMLS CUI [3,1])
C0021044 (UMLS CUI [3,2])
C1512413 (UMLS CUI [4,1])
C0162789 (UMLS CUI [4,2])
C0392920 (UMLS CUI [5,1])
C0205197 (UMLS CUI [5,2])
C0728747 (UMLS CUI [6])
Antioestrogen therapy Breast Carcinoma | Vaccination
Item
patients deemed to require anti-estrogen therapy for treatment of their breast cancer can continue anti-estrogen therapy during vaccinations
boolean
C0854638 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0042196 (UMLS CUI [2])
Childbearing Potential Pregnancy test negative
Item
women of childbearing age with a negative pregnancy test documented prior to enrollment.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
ECOG performance status
Item
subjects with ecog performance status score of 0 or 1 (appendix d).
boolean
C1520224 (UMLS CUI [1])
Contraceptive methods Willing
Item
subjects willing to use birth control if necessary
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Informed Consent
Item
subjects who have voluntarily signed a written informed consent in accordance with institutional policies after its contents have been fully explained to them.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or lactating females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity | Hepatitis C positive
Item
subjects with positive hiv or hepatitis c at baseline by report.
boolean
C0019699 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
Blood Coagulation Disorders | Thrombocytopenia | Platelet Count measurement | International Normalized Ratio | Partial thromboplastin time finding
Item
subjects with coagulopathies, including thrombocytopenia with platelet count less than 75,000, inr greater than 1.5 and partial thromboplastin time greater than 50 sec
boolean
C0005779 (UMLS CUI [1])
C0040034 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0525032 (UMLS CUI [4])
C1531697 (UMLS CUI [5])
Heart Disease Major | Cardiac ejection fraction MUGA
Item
subjects with major cardiac illness muga less than 50% ef.
boolean
C0018799 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Pre-existing condition Interferes with Clinical Trial | Pharmaceutical Preparations Interfere with Clinical Trial
Item
subjects with pre-existing medical illnesses or medications which might interfere with the study as determined by pi.
boolean
C0521987 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
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