ID

34967

Description

HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer Post Neoadjuvant Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT02061423

Link

https://clinicaltrials.gov/show/NCT02061423

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 NCT02061423

English

Eligibility Breast Cancer NCT02061423

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women ≥ 18 years.
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
subjects with her-2 expressing stage i - iii breast cancer with residual disease in the breast or axillary nodes post-neoadjuvant chemotherapy.
Description

HER2-positive carcinoma of breast TNM Breast tumor staging | Residual Tumor Breast | Residual Tumor Axillary lymph nodes | Status post Chemotherapy Neoadjuvant

Data type

boolean

Alias
UMLS CUI [1,1]
C1960398
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0543478
UMLS CUI [2,2]
C0006141
UMLS CUI [3,1]
C0543478
UMLS CUI [3,2]
C0729594
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0392920
UMLS CUI [4,3]
C0600558
women of childbearing age with a negative pregnancy serum test documented prior to enrollment.
Description

Childbearing Potential Serum pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
subjects with ecog performance status score of 0 or 1.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
women of childbearing potential must agree to use a medically acceptable form of birth control (medically accepted methods: birth control pills, condoms and spermicidal lubricants, intrauterine device, and diaphragm) during their participation in the study.
Description

Childbearing Potential Contraceptive methods | Contraceptives, Oral | Female Condoms | Lubricants Spermicidal | Intrauterine Devices | Vaginal contraceptive diaphragm

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0009905
UMLS CUI [3]
C0221829
UMLS CUI [4,1]
C0282222
UMLS CUI [4,2]
C0419533
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0042241
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 self 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 <75,000, inr > 1.5 and partial thromboplastin time > 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 muga < 50% ef.
Description

Cardiac ejection fraction MUGA

Data type

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
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 NCT02061423

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women ≥ 18 years.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
HER2-positive carcinoma of breast TNM Breast tumor staging | Residual Tumor Breast | Residual Tumor Axillary lymph nodes | Status post Chemotherapy Neoadjuvant
Item
subjects with her-2 expressing stage i - iii breast cancer with residual disease in the breast or axillary nodes post-neoadjuvant chemotherapy.
boolean
C1960398 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0543478 (UMLS CUI [2,1])
C0006141 (UMLS CUI [2,2])
C0543478 (UMLS CUI [3,1])
C0729594 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0392920 (UMLS CUI [4,2])
C0600558 (UMLS CUI [4,3])
Childbearing Potential Serum pregnancy test negative
Item
women of childbearing age with a negative pregnancy serum test documented prior to enrollment.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
ECOG performance status
Item
subjects with ecog performance status score of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Contraceptives, Oral | Female Condoms | Lubricants Spermicidal | Intrauterine Devices | Vaginal contraceptive diaphragm
Item
women of childbearing potential must agree to use a medically acceptable form of birth control (medically accepted methods: birth control pills, condoms and spermicidal lubricants, intrauterine device, and diaphragm) during their participation in the study.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0009905 (UMLS CUI [2])
C0221829 (UMLS CUI [3])
C0282222 (UMLS CUI [4,1])
C0419533 (UMLS CUI [4,2])
C0021900 (UMLS CUI [5])
C0042241 (UMLS CUI [6])
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 self 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 <75,000, inr > 1.5 and partial thromboplastin time > 50 sec.
boolean
C0005779 (UMLS CUI [1])
C0040034 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0525032 (UMLS CUI [4])
C1531697 (UMLS CUI [5])
Cardiac ejection fraction MUGA
Item
subjects with muga < 50% ef.
boolean
C0232174 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
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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