ID

37755

Description

Riluzole in Women With Stage I, Stage II, or Stage IIIA Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00903214

Link

https://clinicaltrials.gov/show/NCT00903214

Keywords

Versions (1)
  1. 8/21/19 8/21/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 21, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00903214

English

Eligibility Breast Cancer NCT00903214

1 forms  
Criteria
Description

Criteria

diagnosis of adenocarcinoma of the breast
Description

Breast adenocarcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0858252
stage i (t1c)-iiia disease meeting the following criteria:
Description

Disease TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0474926
large enough (> 1 cm) to undergo additional multiple core needle biopsies preoperatively
Description

Tumor size | Core needle biopsy Multiple Preoperative

Data type

boolean

Alias
UMLS CUI [1]
C0475440
UMLS CUI [2,1]
C1318309
UMLS CUI [2,2]
C0439064
UMLS CUI [2,3]
C0445204
surgically resectable for cure or palliation without first requiring neoadjuvant chemotherapy
Description

Tumor Resectable Curative | Tumor Resectable Palliative | Neoadjuvant Chemotherapy Redundant

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1514888
UMLS CUI [1,3]
C1276305
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1514888
UMLS CUI [2,3]
C1285530
UMLS CUI [3,1]
C0600558
UMLS CUI [3,2]
C0392920
UMLS CUI [3,3]
C1313915
patients who have previously been treated for breast cancer, but are judged to have developed a new primary cancer, rather than a recurrence, are eligible
Description

Prior Therapy Breast Carcinoma | Second Primary Cancer newly present

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0751623
UMLS CUI [2,2]
C0750546
UMLS CUI [2,3]
C0150312
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
ecog performance status 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
anc ≥ 1,000/mm³
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelet count ≥ 50,000/mm³
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
liver function tests ≤ 3 times upper limit of normal (uln)
Description

Liver Function Tests

Data type

boolean

Alias
UMLS CUI [1]
C0023901
total bilirubin ≤ 2 times uln
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
creatinine ≤ 1.5 mg/dl
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
inr ≤ 25% normal limits
Description

International Normalized Ratio

Data type

boolean

Alias
UMLS CUI [1]
C0525032
not pregnant or nursing
Description

Pregnancy Absent | Breast Feeding Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
no known history of hiv or aids
Description

HIV Infection Absent | AIDS Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0001175
UMLS CUI [2,2]
C0332197
no known history of hepatitis b or c
Description

Hepatitis B Absent | Hepatitis C Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0019196
UMLS CUI [2,2]
C0332197
no history of vertigo or ménière's type of disorder
Description

Vertigo Absent | Meniere Disease Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0042571
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0025281
UMLS CUI [2,2]
C0332197
no history of allergic reaction to riluzole or similar compounds
Description

Allergic Reaction Absent Riluzole | Allergic Reaction Absent Compound Similar

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0073379
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C1706082
UMLS CUI [2,4]
C2348205
prior concurrent therapy:
Description

Prior Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514463
no prior estrogen blockers, chemotherapy, radiotherapy, biological therapy, or surgery for the treatment of breast cancer
Description

Estrogen Antagonists Absent Breast Carcinoma | Chemotherapy Absent Breast Carcinoma | Therapeutic radiology procedure Absent Breast Carcinoma | Biological treatment Absent Breast Carcinoma | Operative Surgical Procedures Absent Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0014930
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0678222
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0678222
UMLS CUI [4,1]
C1531518
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0678222
UMLS CUI [5,1]
C0543467
UMLS CUI [5,2]
C0332197
UMLS CUI [5,3]
C0678222
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Similar models

Eligibility Breast Cancer NCT00903214

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Breast adenocarcinoma
Item
diagnosis of adenocarcinoma of the breast
boolean
C0858252 (UMLS CUI [1])
Disease TNM Breast tumor staging
Item
stage i (t1c)-iiia disease meeting the following criteria:
boolean
C0012634 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Tumor size | Core needle biopsy Multiple Preoperative
Item
large enough (> 1 cm) to undergo additional multiple core needle biopsies preoperatively
boolean
C0475440 (UMLS CUI [1])
C1318309 (UMLS CUI [2,1])
C0439064 (UMLS CUI [2,2])
C0445204 (UMLS CUI [2,3])
Tumor Resectable Curative | Tumor Resectable Palliative | Neoadjuvant Chemotherapy Redundant
Item
surgically resectable for cure or palliation without first requiring neoadjuvant chemotherapy
boolean
C0027651 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
C1276305 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C1514888 (UMLS CUI [2,2])
C1285530 (UMLS CUI [2,3])
C0600558 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C1313915 (UMLS CUI [3,3])
Prior Therapy Breast Carcinoma | Second Primary Cancer newly present
Item
patients who have previously been treated for breast cancer, but are judged to have developed a new primary cancer, rather than a recurrence, are eligible
boolean
C1514463 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0751623 (UMLS CUI [2,1])
C0750546 (UMLS CUI [2,2])
C0150312 (UMLS CUI [2,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Absolute neutrophil count
Item
anc ≥ 1,000/mm³
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥ 50,000/mm³
boolean
C0032181 (UMLS CUI [1])
Liver Function Tests
Item
liver function tests ≤ 3 times upper limit of normal (uln)
boolean
C0023901 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin ≤ 2 times uln
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine ≤ 1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
International Normalized Ratio
Item
inr ≤ 25% normal limits
boolean
C0525032 (UMLS CUI [1])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
HIV Infection Absent | AIDS Absent
Item
no known history of hiv or aids
boolean
C0019693 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0001175 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Hepatitis B Absent | Hepatitis C Absent
Item
no known history of hepatitis b or c
boolean
C0019163 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0019196 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Vertigo Absent | Meniere Disease Absent
Item
no history of vertigo or ménière's type of disorder
boolean
C0042571 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0025281 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Allergic Reaction Absent Riluzole | Allergic Reaction Absent Compound Similar
Item
no history of allergic reaction to riluzole or similar compounds
boolean
C1527304 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0073379 (UMLS CUI [1,3])
C1527304 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1706082 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
Prior Therapy
Item
prior concurrent therapy:
boolean
C1514463 (UMLS CUI [1])
Estrogen Antagonists Absent Breast Carcinoma | Chemotherapy Absent Breast Carcinoma | Therapeutic radiology procedure Absent Breast Carcinoma | Biological treatment Absent Breast Carcinoma | Operative Surgical Procedures Absent Breast Carcinoma
Item
no prior estrogen blockers, chemotherapy, radiotherapy, biological therapy, or surgery for the treatment of breast cancer
boolean
C0014930 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0678222 (UMLS CUI [3,3])
C1531518 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0678222 (UMLS CUI [4,3])
C0543467 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0678222 (UMLS CUI [5,3])
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