Eligibility Locally Advanced Breast Cancer NCT00437879

1 Formulários

StudyEvent: Eligibility
1. Eligibility Locally Advanced Breast Cancer NCT00437879

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Study Subject Participation Status | Criteria Fulfill

Item

the following criteria are necessary for study participation:

boolean

C2348568 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])

Locally advanced breast cancer | First line treatment Absent | Chemotherapy Neoadjuvant | Chemoradiotherapy Neoadjuvant

Item

1. histologically or cytologically confirmed locally advanced breast carcinoma which has not been treated with any first-line therapy and will be treated with neoadjuvant chemotherapy or neoadjuvant combined chemo-radiotherapy

boolean

C3495949 (UMLS CUI [1])
C1708063 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C0436307 (UMLS CUI [4,1])
C0600558 (UMLS CUI [4,2])

Measurable Disease Ultrasonography | Measurable Disease MRI

Item

2. measurable disease by ultrasound, or mri performed within 28 days prior to treatment

boolean

C1513041 (UMLS CUI [1,1])
C0041618 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])

ECOG performance status

Item

3. eastern co-operative oncology group (ecog) performance status of 0 or 1.

boolean

C1520224 (UMLS CUI [1])

Life Expectancy

Item

4. life expectancy of at least 6 months

boolean

C0023671 (UMLS CUI [1])

Bone Marrow function | Liver function | Renal function

Item

5. adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to dosing:

boolean

C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])

Hemoglobin measurement

Item

hemoglobin >90 mg/dl

boolean

C0518015 (UMLS CUI [1])

White Blood Cell Count procedure

Item

leukocytes >3,000/ml

boolean

C0023508 (UMLS CUI [1])

Absolute neutrophil count

Item

absolute neutrophil count >1,500/ml

boolean

C0948762 (UMLS CUI [1])

Platelet Count measurement

Item

platelets >100,000/ml

boolean

C0032181 (UMLS CUI [1])

Bilirubin total normal

Item

total bilirubin within normal institutional limits

boolean

C0860928 (UMLS CUI [1])

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Item

ast(sgot)/alt(sgpt) <2.5 x institutional upper limit of normal

boolean

C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])

Serum creatinine normal | Creatinine clearance measurement | Serum creatinine raised

Item

creatinine within normal institutional limits or creatinine clearance >60 ml/min/1.73 m2 for patients with creatinine levels above institutional upper limit of normal

boolean

C0438244 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
C0700225 (UMLS CUI [3])

Informed Consent

Item

6. patients should have the ability to understand and the willingness to sign a written informed consent document. signed informed consent must be obtained prior to any study specific procedures

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Gender | Exclusion Criteria

Item

the following conditions will exclude women from participation:

boolean

C0079399 (UMLS CUI [1])
C0680251 (UMLS CUI [2])

Chemotherapy | Therapeutic radiology procedure | Major surgery | Adverse event Due to Pharmaceutical Preparations | Patient Recovery Lacking

Item

1. chemotherapy, radiotherapy, or major surgery within 4 prior to registering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to registration

boolean

C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0679637 (UMLS CUI [3])
C0877248 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0030705 (UMLS CUI [5,1])
C2004454 (UMLS CUI [5,2])
C0332268 (UMLS CUI [5,3])

Investigational New Drugs

Item

2. receiving any other investigational agents

boolean

C0013230 (UMLS CUI [1])

Metastatic malignant neoplasm to brain

Item

3. known brain metastases

boolean

C0220650 (UMLS CUI [1])

Allergic Reaction Compound Chemical Structure Similar

Item

4. history of allergic reactions attributed to compounds of similar chemical or biologic composition

boolean

C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0220807 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])

Medical contraindication Therapeutic radiology procedure

Item

5. contraindications to radiotherapy such as but not limited to:

boolean

C1301624 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])

Prior radiation therapy Area Involved

Item

previous radiotherapy to an involved area

boolean

C0279134 (UMLS CUI [1,1])
C0005902 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])

Collagen-vascular disease

Item

active collagen vascular disease

boolean

C0262428 (UMLS CUI [1])

Hereditary Diseases Associated with Sensitivity to radiation

Item

genetic diseases associated with hyper-radiosensitivity

boolean

C0019247 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0520903 (UMLS CUI [1,3])

Communicable Diseases Serious | Requirement Anti-Bacterial Agents Systemic | Requirement Antifungal Agents Systemic | Requirement Antiviral Agents Systemic

Item

6. any clinically serious infections requiring systemic anti-bacterial, antifungal or antiviral therapy

boolean

C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0279516 (UMLS CUI [2,2])
C0205373 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C0003308 (UMLS CUI [3,2])
C0205373 (UMLS CUI [3,3])
C1514873 (UMLS CUI [4,1])
C0003451 (UMLS CUI [4,2])
C0205373 (UMLS CUI [4,3])

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia

Item

7. uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia

boolean

C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])

Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Item

8. psychiatric illness/social situations that would limit compliance with study requirements

boolean

C0004936 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])

Epilepsy

Item

9. history of active ongoing seizure disorder

boolean

C0014544 (UMLS CUI [1])

Substance Use Disorders Interfere with Study Subject Participation Status | Substance Use Disorders Interfere with Evaluation Research results | Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Evaluation Research results | Mental condition Interferes with Study Subject Participation Status | Mental condition Interferes with Evaluation Research results | Social Conditions Interfere with Study Subject Participation Status | Social Conditions Interfere with Evaluation Research results

Item

10. substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results

boolean

C0038586 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0038586 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1261322 (UMLS CUI [4,3])
C0683954 (UMLS CUI [4,4])
C3840291 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2348568 (UMLS CUI [5,3])
C3840291 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C1261322 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
C0037403 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C2348568 (UMLS CUI [7,3])
C0037403 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C1261322 (UMLS CUI [8,3])
C0683954 (UMLS CUI [8,4])

Patient's condition unstable | Condition compromises Patient safety | Condition compromises Protocol Compliance

Item

11. any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.

boolean

C0438114 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])

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Eligibility Locally Advanced Breast Cancer NCT00437879