ID

38301

Beskrivning

Study of Short-term Fasting on Neoadjuvant Chemotherapy in Patients With Newly Diagnosed Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02379585

Länk

https://clinicaltrials.gov/show/NCT02379585

Nyckelord

Versioner (1)
  1. 2019-10-09 2019-10-09 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

9 oktober 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02379585

Engelsk

Eligibility Breast Cancer NCT02379585

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients ≥ 18 years of age with histologically, and radiographically confirmed non-metastatic breast cancer with minimal tumor size over 1 cm (≥t1c lesion) to receive neoadjuvant chemotherapy recommended by the treating physician
Beskrivning

Age | Breast Carcinoma | Exception Neoplasm Metastasis | Tumor size Minimum | Lesion TNM clinical staging | Neoadjuvant Chemotherapy Recommended

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0678222
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0027627
UMLS CUI [4,1]
C0475440
UMLS CUI [4,2]
C1524031
UMLS CUI [5,1]
C0221198
UMLS CUI [5,2]
C3258246
UMLS CUI [6,1]
C0600558
UMLS CUI [6,2]
C3665472
UMLS CUI [6,3]
C0034866
for estrogen receptor (er) strongly positive, human epithelial receptor (her2) negative breast cancer, oncotype dx study is required. patients with low recurrence score will be excluded in the study.
Beskrivning

Oestrogen receptor positive breast cancer | Human epidermal growth factor 2 negative carcinoma of breast

Datatyp

boolean

Alias
UMLS CUI [1]
C2938924
UMLS CUI [2]
C2316304
eastern cooperative oncology group (ecog) performance status score < 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
absolute neutrophil count > 1500 mm3, platelet count ≥ 100×109 l, hemoglobin ≥ 8.5 g/dl
Beskrivning

Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
serum creatinine ≤1.5 times the upper limit of the normal range, total bilirubin ≤
Beskrivning

Serum creatinine raised | Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0700225
UMLS CUI [2]
C1278039
1.5 x uln (≤ 3 mg/dl if clinically diagnosed with gilbert syndrome) ast/alt ≤ 2.5 x uln (ast/alt ≤ 5x uln if clinically diagnosed with gilbert syndrome)
Beskrivning

Gilbert Disease | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0017551
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
willing to provide blood samples for correlative research purposes
Beskrivning

Collection of blood specimen for laboratory procedure Correlative Study

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1511524
women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial.
Beskrivning

Childbearing Potential Contraceptive methods | Premenopausal state | Female Sterilization Absent | Sexual Abstinence | Contraceptives, Oral | Barrier Contraception Double | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0232969
UMLS CUI [3,1]
C0015787
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0036899
UMLS CUI [5]
C0009905
UMLS CUI [6,1]
C0004764
UMLS CUI [6,2]
C0205173
UMLS CUI [7,1]
C3831118
UMLS CUI [7,2]
C0430057
UMLS CUI [8,1]
C3831118
UMLS CUI [8,2]
C0430061
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. uncontrolled cardiac disease, such as angina, hypertension or significant arrhythmias, congestive heart failure (nyha grade 2 or more or lvef < 40% on any prior assessment). note: assessment of lvef is done before and after anthracycline-based or trastuzumab-based chemotherapy as standard of care
Beskrivning

Heart Disease Uncontrolled | Angina Pectoris | Hypertensive disease | Cardiac Arrhythmia | Congestive heart failure New York Heart Association Classification | Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0020538
UMLS CUI [4]
C0003811
UMLS CUI [5,1]
C0018802
UMLS CUI [5,2]
C1275491
UMLS CUI [6]
C0428772
2. pregnant or lactating females
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. known history of diabetes mellitus. if screening fasting glucose is ≥126 mg/dl, an hba1c must be < 6.5%.
Beskrivning

Diabetes Mellitus | Glucose measurement, fasting | Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0202045
UMLS CUI [3]
C0474680
4. history of syncope with calorie restriction in the past
Beskrivning

Syncope | Low-Calorie Diet

Datatyp

boolean

Alias
UMLS CUI [1]
C0039070
UMLS CUI [2]
C2930544
5. body mass index (bmi) < 19 kg/m2
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
6. clinical signs or symptoms of gi obstruction and/or requirement for parenteral hydration or nutrition
Beskrivning

Sign or Symptom Gastrointestinal obstruction | Requirement Parenteral fluids for hydration | Requirement Parenteral Nutrition

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0236124
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C1514873
UMLS CUI [3]
C2034480
UMLS CUI [4]
C0030547
7. inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
Beskrivning

Informed Consent Unable | Protocol Compliance Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
8. concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements
Beskrivning

Comorbidity Severe | Communicable Disease | Mental disorder Limiting Safety | Social situation Limiting Safety | Mental disorder Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0009450
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0439801
UMLS CUI [3,3]
C0036043
UMLS CUI [4,1]
C0748872
UMLS CUI [4,2]
C0439801
UMLS CUI [4,3]
C0036043
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0439801
UMLS CUI [5,3]
C0525058
UMLS CUI [6,1]
C0748872
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0525058
9. any other medical comorbidity that requires daily medication(s) that may not be safely taken without food.
Beskrivning

Comorbidity Requirement Pharmaceutical Preparations Daily

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C0332173
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Similar models

Eligibility Breast Cancer NCT02379585

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Breast Carcinoma | Exception Neoplasm Metastasis | Tumor size Minimum | Lesion TNM clinical staging | Neoadjuvant Chemotherapy Recommended
Item
patients ≥ 18 years of age with histologically, and radiographically confirmed non-metastatic breast cancer with minimal tumor size over 1 cm (≥t1c lesion) to receive neoadjuvant chemotherapy recommended by the treating physician
boolean
C0001779 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C0475440 (UMLS CUI [4,1])
C1524031 (UMLS CUI [4,2])
C0221198 (UMLS CUI [5,1])
C3258246 (UMLS CUI [5,2])
C0600558 (UMLS CUI [6,1])
C3665472 (UMLS CUI [6,2])
C0034866 (UMLS CUI [6,3])
Oestrogen receptor positive breast cancer | Human epidermal growth factor 2 negative carcinoma of breast
Item
for estrogen receptor (er) strongly positive, human epithelial receptor (her2) negative breast cancer, oncotype dx study is required. patients with low recurrence score will be excluded in the study.
boolean
C2938924 (UMLS CUI [1])
C2316304 (UMLS CUI [2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status score < 1
boolean
C1520224 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
absolute neutrophil count > 1500 mm3, platelet count ≥ 100×109 l, hemoglobin ≥ 8.5 g/dl
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Serum creatinine raised | Serum total bilirubin measurement
Item
serum creatinine ≤1.5 times the upper limit of the normal range, total bilirubin ≤
boolean
C0700225 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
Gilbert Disease | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
1.5 x uln (≤ 3 mg/dl if clinically diagnosed with gilbert syndrome) ast/alt ≤ 2.5 x uln (ast/alt ≤ 5x uln if clinically diagnosed with gilbert syndrome)
boolean
C0017551 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Collection of blood specimen for laboratory procedure Correlative Study
Item
willing to provide blood samples for correlative research purposes
boolean
C0005834 (UMLS CUI [1,1])
C1511524 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods | Premenopausal state | Female Sterilization Absent | Sexual Abstinence | Contraceptives, Oral | Barrier Contraception Double | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative
Item
women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0232969 (UMLS CUI [2])
C0015787 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0036899 (UMLS CUI [4])
C0009905 (UMLS CUI [5])
C0004764 (UMLS CUI [6,1])
C0205173 (UMLS CUI [6,2])
C3831118 (UMLS CUI [7,1])
C0430057 (UMLS CUI [7,2])
C3831118 (UMLS CUI [8,1])
C0430061 (UMLS CUI [8,2])
Item Group
C0680251 (UMLS CUI)
Heart Disease Uncontrolled | Angina Pectoris | Hypertensive disease | Cardiac Arrhythmia | Congestive heart failure New York Heart Association Classification | Left ventricular ejection fraction
Item
1. uncontrolled cardiac disease, such as angina, hypertension or significant arrhythmias, congestive heart failure (nyha grade 2 or more or lvef < 40% on any prior assessment). note: assessment of lvef is done before and after anthracycline-based or trastuzumab-based chemotherapy as standard of care
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2])
C0020538 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
C0018802 (UMLS CUI [5,1])
C1275491 (UMLS CUI [5,2])
C0428772 (UMLS CUI [6])
Pregnancy | Breast Feeding
Item
2. pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Diabetes Mellitus | Glucose measurement, fasting | Hemoglobin A1c measurement
Item
3. known history of diabetes mellitus. if screening fasting glucose is ≥126 mg/dl, an hba1c must be < 6.5%.
boolean
C0011849 (UMLS CUI [1])
C0202045 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
Syncope | Low-Calorie Diet
Item
4. history of syncope with calorie restriction in the past
boolean
C0039070 (UMLS CUI [1])
C2930544 (UMLS CUI [2])
Body mass index
Item
5. body mass index (bmi) < 19 kg/m2
boolean
C1305855 (UMLS CUI [1])
Sign or Symptom Gastrointestinal obstruction | Requirement Parenteral fluids for hydration | Requirement Parenteral Nutrition
Item
6. clinical signs or symptoms of gi obstruction and/or requirement for parenteral hydration or nutrition
boolean
C3540840 (UMLS CUI [1,1])
C0236124 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C2034480 (UMLS CUI [3])
C0030547 (UMLS CUI [4])
Informed Consent Unable | Protocol Compliance Unable
Item
7. inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Comorbidity Severe | Communicable Disease | Mental disorder Limiting Safety | Social situation Limiting Safety | Mental disorder Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
8. concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0004936 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0036043 (UMLS CUI [3,3])
C0748872 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0036043 (UMLS CUI [4,3])
C0004936 (UMLS CUI [5,1])
C0439801 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0748872 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
Comorbidity Requirement Pharmaceutical Preparations Daily
Item
9. any other medical comorbidity that requires daily medication(s) that may not be safely taken without food.
boolean
C0009488 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0332173 (UMLS CUI [1,4])
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