ID

38006

Description

Study of the Response to a Neoadjuvant Chemotherapy Based on the Antitumor Immune Response in Localized Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01440413

Link

https://clinicaltrials.gov/show/NCT01440413

Keywords

Versions (1)
  1. 9/7/19 9/7/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 7, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01440413

English

Eligibility Breast Cancer NCT01440413

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven localized breast cancer required anthracycline chemotherapy +/-
Description

Breast Carcinoma Localized | Requirement Anthracycline Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0392752
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0282564
UMLS CUI [2,3]
C3665472
trastuzumab before surgery
Description

Requirement Anthracycline In addition to Trastuzumab

Data type

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0282564
UMLS CUI [1,3]
C0332287
UMLS CUI [1,4]
C0728747
age > 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
chemotherapy with 3 anthracycline cycles to begin (doxorubicin or epirubicin)
Description

Anthracycline Chemotherapy cycle Quantity | Doxorubicin | Epirubicin

Data type

boolean

Alias
UMLS CUI [1,1]
C0282564
UMLS CUI [1,2]
C1302181
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0013089
UMLS CUI [3]
C0014582
any previous treatment for this cancer
Description

Prior Therapy Malignant Neoplasm Current

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C0521116
performance status <= 1
Description

Performance status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
agreement for the conservation of biological samples
Description

Agreement Conservation Biospecimen

Data type

boolean

Alias
UMLS CUI [1,1]
C0680240
UMLS CUI [1,2]
C2347858
UMLS CUI [1,3]
C2347026
covered by an medical insurance
Description

Insurance Coverage Medical

Data type

boolean

Alias
UMLS CUI [1,1]
C0376629
UMLS CUI [1,2]
C0205476
signed written informed consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
availability of tumoral sample collected at diagnosis
Description

Availability of Tumor tissue sample

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous surgery for the breast cancer
Description

Operative Surgical Procedure Previous Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0678222
already under chemotherapy before the first blood sample
Description

Chemotherapy Pre-existing

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C2347662
previous antitumoral treatment
Description

Cancer treatment Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
under immunosuppressive treatment
Description

Therapeutic immunosuppression

Data type

boolean

Alias
UMLS CUI [1]
C0021079
under corticoids during the 15 days before enrollment
Description

Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1]
C0001617
history of concomitant cancer except if it has been cured for at least 5 years
Description

Cancer Other | Exception Cancer Other Cured

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1707251
UMLS CUI [2,3]
C1880198
history of lymphoma or breast sarcoma
Description

Lymphoma | Sarcoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C0024299
UMLS CUI [2]
C0349667
history of chronic inflammatory disease or autoimmune disease, hepatitis b or c or immune dysfunction disease (including hiv-positive stage aids) known
Description

Chronic inflammatory disorder | Autoimmune Disease | Hepatitis B | Hepatitis C | Immune System Disease | HIV Seropositivity Stage AIDS

Data type

boolean

Alias
UMLS CUI [1]
C1290886
UMLS CUI [2]
C0004364
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
UMLS CUI [5]
C0021053
UMLS CUI [6,1]
C0019699
UMLS CUI [6,2]
C1306673
UMLS CUI [6,3]
C0001175
history of other disease which is discrepant with this study
Description

Disease Other | Discrepancy Clinical Trial Current

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C1290905
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0521116
deprived of liberty by court or administrative decision
Description

Patient Deprivation Freedom

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0871712
UMLS CUI [1,3]
C0016694
pregnant or breastfeeding women or with no use of effective birth control methods for women of childbearing potential
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
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Similar models

Eligibility Breast Cancer NCT01440413

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma Localized | Requirement Anthracycline Chemotherapy
Item
histologically proven localized breast cancer required anthracycline chemotherapy +/-
boolean
C0678222 (UMLS CUI [1,1])
C0392752 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0282564 (UMLS CUI [2,2])
C3665472 (UMLS CUI [2,3])
Requirement Anthracycline In addition to Trastuzumab
Item
trastuzumab before surgery
boolean
C1514873 (UMLS CUI [1,1])
C0282564 (UMLS CUI [1,2])
C0332287 (UMLS CUI [1,3])
C0728747 (UMLS CUI [1,4])
Age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
Anthracycline Chemotherapy cycle Quantity | Doxorubicin | Epirubicin
Item
chemotherapy with 3 anthracycline cycles to begin (doxorubicin or epirubicin)
boolean
C0282564 (UMLS CUI [1,1])
C1302181 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0013089 (UMLS CUI [2])
C0014582 (UMLS CUI [3])
Prior Therapy Malignant Neoplasm Current
Item
any previous treatment for this cancer
boolean
C1514463 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
Performance status
Item
performance status <= 1
boolean
C1518965 (UMLS CUI [1])
Agreement Conservation Biospecimen
Item
agreement for the conservation of biological samples
boolean
C0680240 (UMLS CUI [1,1])
C2347858 (UMLS CUI [1,2])
C2347026 (UMLS CUI [1,3])
Insurance Coverage Medical
Item
covered by an medical insurance
boolean
C0376629 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
Informed Consent
Item
signed written informed consent form
boolean
C0021430 (UMLS CUI [1])
Availability of Tumor tissue sample
Item
availability of tumoral sample collected at diagnosis
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Operative Surgical Procedure Previous Breast Carcinoma
Item
previous surgery for the breast cancer
boolean
C0543467 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Chemotherapy Pre-existing
Item
already under chemotherapy before the first blood sample
boolean
C0392920 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Cancer treatment Previous
Item
previous antitumoral treatment
boolean
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Therapeutic immunosuppression
Item
under immunosuppressive treatment
boolean
C0021079 (UMLS CUI [1])
Adrenal Cortex Hormones
Item
under corticoids during the 15 days before enrollment
boolean
C0001617 (UMLS CUI [1])
Cancer Other | Exception Cancer Other Cured
Item
history of concomitant cancer except if it has been cured for at least 5 years
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1707251 (UMLS CUI [2,2])
C1880198 (UMLS CUI [2,3])
Lymphoma | Sarcoma of breast
Item
history of lymphoma or breast sarcoma
boolean
C0024299 (UMLS CUI [1])
C0349667 (UMLS CUI [2])
Chronic inflammatory disorder | Autoimmune Disease | Hepatitis B | Hepatitis C | Immune System Disease | HIV Seropositivity Stage AIDS
Item
history of chronic inflammatory disease or autoimmune disease, hepatitis b or c or immune dysfunction disease (including hiv-positive stage aids) known
boolean
C1290886 (UMLS CUI [1])
C0004364 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
C0021053 (UMLS CUI [5])
C0019699 (UMLS CUI [6,1])
C1306673 (UMLS CUI [6,2])
C0001175 (UMLS CUI [6,3])
Disease Other | Discrepancy Clinical Trial Current
Item
history of other disease which is discrepant with this study
boolean
C0012634 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1290905 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0521116 (UMLS CUI [2,3])
Patient Deprivation Freedom
Item
deprived of liberty by court or administrative decision
boolean
C0030705 (UMLS CUI [1,1])
C0871712 (UMLS CUI [1,2])
C0016694 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
pregnant or breastfeeding women or with no use of effective birth control methods for women of childbearing potential
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
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