ID

38106

Beskrivning

A Phase III Trial of Carboplatin as Adjuvant Chemotherapy in Triple Negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01752686

Länk

https://clinicaltrials.gov/show/NCT01752686

Nyckelord

Versioner (1)
  1. 2019-09-17 2019-09-17 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

17 september 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01752686

Engelsk

Eligibility Breast Cancer NCT01752686

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of breast cancer
Beskrivning

Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0678222
1. female patients
Beskrivning

Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
2. histologically confirmed invasive breast cancer
Beskrivning

Invasive carcinoma of breast

Datatyp

boolean

Alias
UMLS CUI [1]
C0853879
1. primary tumor greater than 2cm diameter, measured by mammography and sonography
Beskrivning

Primary tumor Diameter Mammography | Primary tumor Diameter Ultrasonography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0024671
UMLS CUI [2,1]
C0677930
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0041618
2. any n
Beskrivning

Lymph nodes TNM Breast tumor staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0474926
3. er (estrogen receptor)/ pr (progesterone receptor) / her2 (negative/ negative/
Beskrivning

Estrogen receptor negative Immunohistochemistry | Progesterone receptor negative Immunohistochemistry | HER2 Negative Immunohistochemistry | Estrogen receptor negative FISH | Progesterone receptor negative FISH | HER2 Negative FISH

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279756
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C0279766
UMLS CUI [2,2]
C0021044
UMLS CUI [3,1]
C2348908
UMLS CUI [3,2]
C0021044
UMLS CUI [4,1]
C0279756
UMLS CUI [4,2]
C0162789
UMLS CUI [5,1]
C0279766
UMLS CUI [5,2]
C0162789
UMLS CUI [6,1]
C2348908
UMLS CUI [6,2]
C0162789
negative)(er <1%, pr<1%, ihc 0, 1+ or fish - in case of ihc (immuno-histochemistry) 2+)
Beskrivning

ID.7

Datatyp

boolean

4. no evidence of metastasis (m0)
Beskrivning

Neoplasm Metastasis Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332197
5. no prior hormonal, chemotherapy or radiotherapy is allowed.
Beskrivning

Hormone Therapy Absent | Chemotherapy Absent | Therapeutic radiology procedure Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0332197
6. no breast operation other than biopsy to make diagnosis is allowed.
Beskrivning

Operation on breast Absent | Exception Biopsy of breast

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3714726
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0405352
7. age: 20-years and older, not pregnant pre-, and postmenopausal women with good performance status (ecog 0-1)
Beskrivning

Age | Pregnancy Absent | Postmenopausal state | ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0232970
UMLS CUI [4]
C1520224
8. adequate hematopoietic function: absolute granulocyte count 1500/mm3, platelet 100,000/mm3, hemoglobin 10 g/mm3
Beskrivning

Hematologic function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
9. adequate renal function: serum creatinine 1.5 mg/dl
Beskrivning

Renal function | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
10. adequate hepatic function: total bilirubin: 1.5 mg/dl, ast(aspartate aminotransferase)/alt (alanine transaminase): 2 times normal, alkaline phosphatase:2 times normal
Beskrivning

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase increased | Alanine aminotransferase increased | Alkaline phosphatase raised

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151905
UMLS CUI [5]
C0151849
11. written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
12. normal mental function to understand and sign the consent
Beskrivning

Cognitive functions Normal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392335
UMLS CUI [1,2]
C0205307
13. cardiac function: normal or nonspecific ekg taken within 1 mo of enrollment.
Beskrivning

Cardiac function | ECG normal

Datatyp

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0522054
14. lvef (left ventricular ejection fraction)50% by muga (multiple gated acquisition scan) or echocardiogram taken within 1 mo of enrollment
Beskrivning

Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0521317
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0013516
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who received hormonal, chemotherapy or radiotherapy for breast cancer
Beskrivning

Hormone Therapy Breast Carcinoma | Chemotherapy Breast Carcinoma | Therapeutic radiology procedure Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0678222
2. patients who underwent surgery for breast cancer
Beskrivning

Operative Surgical Procedure Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0678222
3. patients with a history of uncompensated congestive heart failure
Beskrivning

Congestive heart failure Uncompensated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0205433
4. patients with inflammatory breast cancer (t4d)
Beskrivning

Inflammatory Breast Carcinoma TNM Breast tumor staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0278601
UMLS CUI [1,2]
C0474926
5. patients without primary tumor (t0)
Beskrivning

Primary tumor Absent TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C3258246
6. patients who have history of cancer other than in situ uterine cervix cancer or non-melanotic skin cancer
Beskrivning

Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
7. known hypersensitivity to any of the study drugs
Beskrivning

Hypersensitivity Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
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Similar models

Eligibility Breast Cancer NCT01752686

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma
Item
clinical diagnosis of breast cancer
boolean
C0678222 (UMLS CUI [1])
Gender
Item
1. female patients
boolean
C0079399 (UMLS CUI [1])
Invasive carcinoma of breast
Item
2. histologically confirmed invasive breast cancer
boolean
C0853879 (UMLS CUI [1])
Primary tumor Diameter Mammography | Primary tumor Diameter Ultrasonography
Item
1. primary tumor greater than 2cm diameter, measured by mammography and sonography
boolean
C0677930 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0024671 (UMLS CUI [1,3])
C0677930 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0041618 (UMLS CUI [2,3])
Lymph nodes TNM Breast tumor staging
Item
2. any n
boolean
C0024204 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Estrogen receptor negative Immunohistochemistry | Progesterone receptor negative Immunohistochemistry | HER2 Negative Immunohistochemistry | Estrogen receptor negative FISH | Progesterone receptor negative FISH | HER2 Negative FISH
Item
3. er (estrogen receptor)/ pr (progesterone receptor) / her2 (negative/ negative/
boolean
C0279756 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0279766 (UMLS CUI [2,1])
C0021044 (UMLS CUI [2,2])
C2348908 (UMLS CUI [3,1])
C0021044 (UMLS CUI [3,2])
C0279756 (UMLS CUI [4,1])
C0162789 (UMLS CUI [4,2])
C0279766 (UMLS CUI [5,1])
C0162789 (UMLS CUI [5,2])
C2348908 (UMLS CUI [6,1])
C0162789 (UMLS CUI [6,2])
ID.7
Item
negative)(er <1%, pr<1%, ihc 0, 1+ or fish - in case of ihc (immuno-histochemistry) 2+)
boolean
Neoplasm Metastasis Absent
Item
4. no evidence of metastasis (m0)
boolean
C0027627 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Hormone Therapy Absent | Chemotherapy Absent | Therapeutic radiology procedure Absent
Item
5. no prior hormonal, chemotherapy or radiotherapy is allowed.
boolean
C0279025 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Operation on breast Absent | Exception Biopsy of breast
Item
6. no breast operation other than biopsy to make diagnosis is allowed.
boolean
C3714726 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0405352 (UMLS CUI [2,2])
Age | Pregnancy Absent | Postmenopausal state | ECOG performance status
Item
7. age: 20-years and older, not pregnant pre-, and postmenopausal women with good performance status (ecog 0-1)
boolean
C0001779 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0232970 (UMLS CUI [3])
C1520224 (UMLS CUI [4])
Hematologic function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
8. adequate hematopoietic function: absolute granulocyte count 1500/mm3, platelet 100,000/mm3, hemoglobin 10 g/mm3
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Renal function | Creatinine measurement, serum
Item
9. adequate renal function: serum creatinine 1.5 mg/dl
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase increased | Alanine aminotransferase increased | Alkaline phosphatase raised
Item
10. adequate hepatic function: total bilirubin: 1.5 mg/dl, ast(aspartate aminotransferase)/alt (alanine transaminase): 2 times normal, alkaline phosphatase:2 times normal
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
C0151849 (UMLS CUI [5])
Informed Consent
Item
11. written informed consent
boolean
C0021430 (UMLS CUI [1])
Cognitive functions Normal
Item
12. normal mental function to understand and sign the consent
boolean
C0392335 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Cardiac function | ECG normal
Item
13. cardiac function: normal or nonspecific ekg taken within 1 mo of enrollment.
boolean
C0232164 (UMLS CUI [1])
C0522054 (UMLS CUI [2])
Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography
Item
14. lvef (left ventricular ejection fraction)50% by muga (multiple gated acquisition scan) or echocardiogram taken within 1 mo of enrollment
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Hormone Therapy Breast Carcinoma | Chemotherapy Breast Carcinoma | Therapeutic radiology procedure Breast Carcinoma
Item
1. patients who received hormonal, chemotherapy or radiotherapy for breast cancer
boolean
C0279025 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
Operative Surgical Procedure Breast Carcinoma
Item
2. patients who underwent surgery for breast cancer
boolean
C0543467 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Congestive heart failure Uncompensated
Item
3. patients with a history of uncompensated congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C0205433 (UMLS CUI [1,2])
Inflammatory Breast Carcinoma TNM Breast tumor staging
Item
4. patients with inflammatory breast cancer (t4d)
boolean
C0278601 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Primary tumor Absent TNM clinical staging
Item
5. patients without primary tumor (t0)
boolean
C0677930 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma
Item
6. patients who have history of cancer other than in situ uterine cervix cancer or non-melanotic skin cancer
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
Hypersensitivity Investigational New Drugs
Item
7. known hypersensitivity to any of the study drugs
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
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