ID

14872

Description

Vaccination of High Risk Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02229084

Link

https://clinicaltrials.gov/show/NCT02229084

Keywords

Versions (1)
  1. 5/2/16 5/2/16 -
Uploaded on

May 2, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT02229084

English

Eligibility Breast Neoplasms NCT02229084

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
females of all races with clinical stage i, ii, or iii er-positive breast cancer who qualify for standard neoadjuvant treatment
Description

Gender | Racial group | Estrogen receptor positive status [ER+] Breast Carcinoma | Tumor Stage Classification | Neoadjuvant Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0034510
UMLS CUI [3,1]
C1719706
UMLS CUI [3,2]
C0678222
UMLS CUI [4]
C0178759
UMLS CUI [5]
C0600558
age 18 years and older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status 0 or 1.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
white blood cell (wbc) count ≥ 3,000/mm3 within 2 weeks prior to registration.
Description

White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1]
C0023508
platelet count ≥ 100,000/mm3 within 2 weeks prior to registration.
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
serum glutamic-oxaloacetic transaminase (sgot) ≤ 2 x institutional upper limit (iul) of normal obtained within 2 weeks prior to registration.
Description

SGOT - Glutamate oxaloacetate transaminase | Upper Limit of Normal

Data type

boolean

Alias
UMLS CUI [1]
C0242192
UMLS CUI [2]
C1519815
aspartate aminotransferase test (ast) ≤ 2 x institutional upper limit (iul) of normal obtained within 2 weeks prior to registration.
Description

Aspartate aminotransferase measurement | Upper Limit of Normal

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C1519815
bilirubin ≤ 2 x institutional upper limit (iul) of normal obtained within 2 weeks prior to registration.
Description

Bilirubin, total measurement | Upper Limit of Normal

Data type

boolean

Alias
UMLS CUI [1]
C0201913
UMLS CUI [2]
C1519815
serum creatinine ≤ 1.8 mg/dl obtained within 2 weeks prior to registration.
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
must sign an informed consent approved by the uams institutional review board (irb).
Description

Informed Consent Institutional Review Board Approval

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2346499
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active infection requiring treatment with antibiotics.
Description

Communicable Diseases Requirement Antibiotic therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0338237
diagnosis or evidence of organic brain syndrome that might preclude participation in the full protocol.
Description

Organic brain syndrome | Study Subject Participation Status Limited

Data type

boolean

Alias
UMLS CUI [1]
C0029221
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0439801
diagnosis or evidence of significant impairment of basal cognitive function that might preclude participation in the full protocol.
Description

Impaired cognition | Study Subject Participation Status Limited

Data type

boolean

Alias
UMLS CUI [1]
C0338656
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0439801
no other current malignancies. subjects with prior history at any time of any in situ cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or clark i melanoma in situ or basal or squamous skin cancer are eligible, provided they are disease-free at the time of registration. subjects with other malignancies are eligible if they have been continuously disease free for ≥ 5 years prior to the time of registration.
Description

Malignant Neoplasms | In situ cancer | Lobular carcinoma in situ of breast | Carcinoma in situ of uterine cervix | Atypical melanocytic hyperplasia | Clark melanoma level 1 | Basal cell carcinoma | Squamous cell carcinoma of skin

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0851135
UMLS CUI [3]
C0279563
UMLS CUI [4]
C0851140
UMLS CUI [5]
C1265952
UMLS CUI [6]
C0205598
UMLS CUI [7]
C0007117
UMLS CUI [8]
C0553723
autoimmune disorders or conditions of immunosuppression. this includes, but is not limited to being treated with corticosteroids, including oral steroids (i.e. prednisone, dexamethasone [except when used as an antiemetic in standard therapy]), continuous use of topical steroid creams or ointments or any steroid-containing inhalers. subjects who discontinue the use of these classes of medication for at least 6 weeks prior to registration are eligible if, in the judgment of the treating physician, the subject is not likely to require these classes of drugs during the treatment period. replacement doses of steroids for subjects with adrenal insufficiency are allowed.
Description

Autoimmune Diseases | Immune System and Related Disorders | Therapeutic procedure | Adrenal Cortex Hormones | Prednisone | Dexamethasone | Antiemetics | Steroid Cream

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C1334156
UMLS CUI [3]
C0087111
UMLS CUI [4]
C0001617
UMLS CUI [5]
C0032952
UMLS CUI [6]
C0011777
UMLS CUI [7]
C0003297
UMLS CUI [8]
C2985380
pregnancy or breast feeding (due to the unknown effects of peptide/mimotope vaccines on a fetus or infant). women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study drug and must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment and for a period of 18 months after completing or discontinuing treatment. accepted methods of contraception include oral contraceptives, barrier methods, iuds, and abstinence.
Description

Pregnancy | Breast Feeding | Vaccines, Peptide | Childbearing Potential Urine pregnancy test negative Contraceptive methods | Sexual Abstinence | Contraceptives, Oral | Contraception, Barrier | Intrauterine Devices

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0599934
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0430057
UMLS CUI [4,3]
C0700589
UMLS CUI [5]
C0036899
UMLS CUI [6]
C0009905
UMLS CUI [7]
C0004764
UMLS CUI [8]
C0021900
any other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen.
Description

Other medical condition | Mental disorders | Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1]
C3843040
UMLS CUI [2]
C0004936
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0439801
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Similar models

Eligibility Breast Neoplasms NCT02229084

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Racial group | Estrogen receptor positive status [ER+] Breast Carcinoma | Tumor Stage Classification | Neoadjuvant Therapy
Item
females of all races with clinical stage i, ii, or iii er-positive breast cancer who qualify for standard neoadjuvant treatment
boolean
C0079399 (UMLS CUI [1])
C0034510 (UMLS CUI [2])
C1719706 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C0178759 (UMLS CUI [4])
C0600558 (UMLS CUI [5])
Age
Item
age 18 years and older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0 or 1.
boolean
C1520224 (UMLS CUI [1])
White Blood Cell Count procedure
Item
white blood cell (wbc) count ≥ 3,000/mm3 within 2 weeks prior to registration.
boolean
C0023508 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥ 100,000/mm3 within 2 weeks prior to registration.
boolean
C0032181 (UMLS CUI [1])
SGOT - Glutamate oxaloacetate transaminase | Upper Limit of Normal
Item
serum glutamic-oxaloacetic transaminase (sgot) ≤ 2 x institutional upper limit (iul) of normal obtained within 2 weeks prior to registration.
boolean
C0242192 (UMLS CUI [1])
C1519815 (UMLS CUI [2])
Aspartate aminotransferase measurement | Upper Limit of Normal
Item
aspartate aminotransferase test (ast) ≤ 2 x institutional upper limit (iul) of normal obtained within 2 weeks prior to registration.
boolean
C0201899 (UMLS CUI [1])
C1519815 (UMLS CUI [2])
Bilirubin, total measurement | Upper Limit of Normal
Item
bilirubin ≤ 2 x institutional upper limit (iul) of normal obtained within 2 weeks prior to registration.
boolean
C0201913 (UMLS CUI [1])
C1519815 (UMLS CUI [2])
Creatinine measurement, serum
Item
serum creatinine ≤ 1.8 mg/dl obtained within 2 weeks prior to registration.
boolean
C0201976 (UMLS CUI [1])
Informed Consent Institutional Review Board Approval
Item
must sign an informed consent approved by the uams institutional review board (irb).
boolean
C0021430 (UMLS CUI [1,1])
C2346499 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Communicable Diseases Requirement Antibiotic therapy
Item
active infection requiring treatment with antibiotics.
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0338237 (UMLS CUI [1,3])
Organic brain syndrome | Study Subject Participation Status Limited
Item
diagnosis or evidence of organic brain syndrome that might preclude participation in the full protocol.
boolean
C0029221 (UMLS CUI [1])
C2348568 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Impaired cognition | Study Subject Participation Status Limited
Item
diagnosis or evidence of significant impairment of basal cognitive function that might preclude participation in the full protocol.
boolean
C0338656 (UMLS CUI [1])
C2348568 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Malignant Neoplasms | In situ cancer | Lobular carcinoma in situ of breast | Carcinoma in situ of uterine cervix | Atypical melanocytic hyperplasia | Clark melanoma level 1 | Basal cell carcinoma | Squamous cell carcinoma of skin
Item
no other current malignancies. subjects with prior history at any time of any in situ cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or clark i melanoma in situ or basal or squamous skin cancer are eligible, provided they are disease-free at the time of registration. subjects with other malignancies are eligible if they have been continuously disease free for ≥ 5 years prior to the time of registration.
boolean
C0006826 (UMLS CUI [1])
C0851135 (UMLS CUI [2])
C0279563 (UMLS CUI [3])
C0851140 (UMLS CUI [4])
C1265952 (UMLS CUI [5])
C0205598 (UMLS CUI [6])
C0007117 (UMLS CUI [7])
C0553723 (UMLS CUI [8])
Autoimmune Diseases | Immune System and Related Disorders | Therapeutic procedure | Adrenal Cortex Hormones | Prednisone | Dexamethasone | Antiemetics | Steroid Cream
Item
autoimmune disorders or conditions of immunosuppression. this includes, but is not limited to being treated with corticosteroids, including oral steroids (i.e. prednisone, dexamethasone [except when used as an antiemetic in standard therapy]), continuous use of topical steroid creams or ointments or any steroid-containing inhalers. subjects who discontinue the use of these classes of medication for at least 6 weeks prior to registration are eligible if, in the judgment of the treating physician, the subject is not likely to require these classes of drugs during the treatment period. replacement doses of steroids for subjects with adrenal insufficiency are allowed.
boolean
C0004364 (UMLS CUI [1])
C1334156 (UMLS CUI [2])
C0087111 (UMLS CUI [3])
C0001617 (UMLS CUI [4])
C0032952 (UMLS CUI [5])
C0011777 (UMLS CUI [6])
C0003297 (UMLS CUI [7])
C2985380 (UMLS CUI [8])
Pregnancy | Breast Feeding | Vaccines, Peptide | Childbearing Potential Urine pregnancy test negative Contraceptive methods | Sexual Abstinence | Contraceptives, Oral | Contraception, Barrier | Intrauterine Devices
Item
pregnancy or breast feeding (due to the unknown effects of peptide/mimotope vaccines on a fetus or infant). women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study drug and must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment and for a period of 18 months after completing or discontinuing treatment. accepted methods of contraception include oral contraceptives, barrier methods, iuds, and abstinence.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0599934 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0430057 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
C0036899 (UMLS CUI [5])
C0009905 (UMLS CUI [6])
C0004764 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
Other medical condition | Mental disorders | Compliance behavior Limited
Item
any other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen.
boolean
C3843040 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C1321605 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
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