ID

16364

Description

A Study of Women With an Early Diagnosis of Breast Cancer, Taking Celecoxib Between the Biopsy and Lumpectomy/Mastectomy; ODM derived from: https://clinicaltrials.gov/show/NCT00328432

Link

https://clinicaltrials.gov/show/NCT00328432

Keywords

Versions (2)
  1. 7/12/16 7/12/16 -
  2. 7/12/16 7/12/16 -
Uploaded on

July 12, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00328432

English

Eligibility Breast Cancer NCT00328432

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women with a recent diagnosis of t1 or t2 non-invasive breast cancer by large core needle or excisional biopsy
Description

Gender | Invasive carcinoma of breast | Core needle biopsy | Excision biopsy | TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0853879
UMLS CUI [3]
C1318309
UMLS CUI [4]
C0184921
UMLS CUI [5]
C3258246
confirmation that tissue was processed in methods acceptable to protocol and sufficient tissue remains post-diagnostic analyses to perform research assessments
Description

tissue analysis Acceptable | Breast tissue sample; Sufficient; Evaluation Research

Data type

boolean

Alias
UMLS CUI [1,1]
C3161513
UMLS CUI [1,2]
C1879533
UMLS CUI [2,1]
C0444070
UMLS CUI [2,2]
C0205410
UMLS CUI [2,3]
C0015195
reexcision planned within 10 days to 6 weeks from study start
Description

Reexcision Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0184913
UMLS CUI [1,2]
C1301732
if on prevention tamoxifen or raloxifene, must have begun administration at least six weeks prior to initial biopsy and continue through reexcision
Description

Tamoxifen | Raloxifene | Administration Duration

Data type

boolean

Alias
UMLS CUI [1]
C0039286
UMLS CUI [2]
C0244404
UMLS CUI [3,1]
C1533734
UMLS CUI [3,2]
C0449238
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
no hormone replacement therapy within the 90 days prior to biopsy
Description

Hormone replacement therapy Before Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0282402
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0005558
if on prevention tamoxifen or raloxifene, must have begun administration at least six weeks prior to initial biopsy and continue through reexcision
Description

Tamoxifen | Raloxifene | Administration Duration

Data type

boolean

Alias
UMLS CUI [1]
C0039286
UMLS CUI [2]
C0244404
UMLS CUI [3,1]
C1533734
UMLS CUI [3,2]
C0449238
no evidence of metastatic malignancy of any kind
Description

Metastatic Neoplasm Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C2939420
UMLS CUI [1,2]
C0332120
no history of asthma, allergy asa, nsaids, celecoxib or other cox-2 inhibitors for a chronic non-oncological condition with the excision of low dose asa (160 mg daily) during 4 weeks prior to biopsy and for the duration of the study.
Description

Asthma | Hypersensitivity Aspirin | Anti-Inflammatory Agents, Non-Steroidal | celecoxib | Cyclooxygenase 2 Inhibitors | Condition Non-Malignant chronic | Low Dose ASA

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0004057
UMLS CUI [3]
C0003211
UMLS CUI [4]
C0538927
UMLS CUI [5]
C1257954
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C1518371
UMLS CUI [6,3]
C0205191
UMLS CUI [7]
C0721444
no celecoxib or rofecoxib use within one month of biopsy
Description

celecoxib Use of | rofecoxib Use of

Data type

boolean

Alias
UMLS CUI [1,1]
C0538927
UMLS CUI [1,2]
C1524063
UMLS CUI [2,1]
C0762662
UMLS CUI [2,2]
C1524063
no history of gastrointestinal ulcer or ulcerative colitis requiring treatment
Description

Gastrointestinal ulcer Requirement Therapeutic procedure | Ulcerative Colitis Requirement Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0237938
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0009324
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0087111
no current anticoagulants
Description

Anticoagulants

Data type

boolean

Alias
UMLS CUI [1]
C0003280
no neoadjuvant antihormone or chemotherapy as treatment following biopsy prior to study entry or concurrently with participation on study
Description

Antihormone Therapy Neoadjuvant | Chemotherapy Neoadjuvant

Data type

boolean

Alias
UMLS CUI [1,1]
C2986607
UMLS CUI [1,2]
C0600558
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0600558
no aromatase inhibitor in the six months prior to participation
Description

Aromatase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0593802
no concomitant lithium
Description

Lithium

Data type

boolean

Alias
UMLS CUI [1]
C0023870
no known significant bleeding disorder
Description

Blood Coagulation Disorder Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C0750502
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Similar models

Eligibility Breast Cancer NCT00328432

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Invasive carcinoma of breast | Core needle biopsy | Excision biopsy | TNM clinical staging
Item
women with a recent diagnosis of t1 or t2 non-invasive breast cancer by large core needle or excisional biopsy
boolean
C0079399 (UMLS CUI [1])
C0853879 (UMLS CUI [2])
C1318309 (UMLS CUI [3])
C0184921 (UMLS CUI [4])
C3258246 (UMLS CUI [5])
tissue analysis Acceptable | Breast tissue sample; Sufficient; Evaluation Research
Item
confirmation that tissue was processed in methods acceptable to protocol and sufficient tissue remains post-diagnostic analyses to perform research assessments
boolean
C3161513 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C0444070 (UMLS CUI [2,1])
C0205410 (UMLS CUI [2,2])
C0015195 (UMLS CUI [2,3])
Reexcision Planned
Item
reexcision planned within 10 days to 6 weeks from study start
boolean
C0184913 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Tamoxifen | Raloxifene | Administration Duration
Item
if on prevention tamoxifen or raloxifene, must have begun administration at least six weeks prior to initial biopsy and continue through reexcision
boolean
C0039286 (UMLS CUI [1])
C0244404 (UMLS CUI [2])
C1533734 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Hormone replacement therapy Before Biopsy
Item
no hormone replacement therapy within the 90 days prior to biopsy
boolean
C0282402 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
Tamoxifen | Raloxifene | Administration Duration
Item
if on prevention tamoxifen or raloxifene, must have begun administration at least six weeks prior to initial biopsy and continue through reexcision
boolean
C0039286 (UMLS CUI [1])
C0244404 (UMLS CUI [2])
C1533734 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
Metastatic Neoplasm Evidence of
Item
no evidence of metastatic malignancy of any kind
boolean
C2939420 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Asthma | Hypersensitivity Aspirin | Anti-Inflammatory Agents, Non-Steroidal | celecoxib | Cyclooxygenase 2 Inhibitors | Condition Non-Malignant chronic | Low Dose ASA
Item
no history of asthma, allergy asa, nsaids, celecoxib or other cox-2 inhibitors for a chronic non-oncological condition with the excision of low dose asa (160 mg daily) during 4 weeks prior to biopsy and for the duration of the study.
boolean
C0004096 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0004057 (UMLS CUI [2,2])
C0003211 (UMLS CUI [3])
C0538927 (UMLS CUI [4])
C1257954 (UMLS CUI [5])
C0348080 (UMLS CUI [6,1])
C1518371 (UMLS CUI [6,2])
C0205191 (UMLS CUI [6,3])
C0721444 (UMLS CUI [7])
celecoxib Use of | rofecoxib Use of
Item
no celecoxib or rofecoxib use within one month of biopsy
boolean
C0538927 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0762662 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
Gastrointestinal ulcer Requirement Therapeutic procedure | Ulcerative Colitis Requirement Therapeutic procedure
Item
no history of gastrointestinal ulcer or ulcerative colitis requiring treatment
boolean
C0237938 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0009324 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Anticoagulants
Item
no current anticoagulants
boolean
C0003280 (UMLS CUI [1])
Antihormone Therapy Neoadjuvant | Chemotherapy Neoadjuvant
Item
no neoadjuvant antihormone or chemotherapy as treatment following biopsy prior to study entry or concurrently with participation on study
boolean
C2986607 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
Aromatase Inhibitors
Item
no aromatase inhibitor in the six months prior to participation
boolean
C0593802 (UMLS CUI [1])
Lithium
Item
no concomitant lithium
boolean
C0023870 (UMLS CUI [1])
Blood Coagulation Disorder Significant
Item
no known significant bleeding disorder
boolean
C0005779 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
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