Inglês

Eligibility Criteria

6 Formulários  
  1. StudyEvent: SEV1
    1. Eligibility Criteria
    2. Subject ID, consent group, subject source, and subject source ID of participants with primary breast cancer and involved in the "Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial (SUCCESS-Trial)" project.
    3. Subject ID, family ID, father and mother IDs, and sex of participants with primary breast cancer and involved in the "Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial (SUCCESS-Trial)" project.
    4. Sample ID, subject ID, sample source, sample source ID, and sample use variables obtained from participants with primary breast cancer and involved in the "Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial (SUCCESS-Trial)" project.
    5. Subject ID, age, height, weight, tumor grade, tumor stage, histology of tumor, tumor ER, HER2, and PR status, menopause status, tumor progression and death of participants with primary breast cancer and involved in the "Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial (SUCCESS-Trial)" project.
    6. Sample ID, body site where sample was collected, analyte type of samples, tumor status, and histological type of samples obtained from participants with primary breast cancer and involved in the "Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial (SUCCESS-Trial)" project.
Inclusion and exclusion criteria
Descrição

Inclusion and exclusion criteria

Patients may be *included* in the study only if they meet *all* the following criteria:
Descrição

Patients may be *included* in the study only if they meet *all* the following criteria:

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1512693
Primary epithelial invasive carcinoma of the breast pT1-4, pM0
Descrição

Primary epithelial invasive carcinoma of the breast pT1-4, pM0

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C4076461
Histopathological proof of axillary lymph node metastases (pN1-3) *or* high risk pN0/NX, defined as: pT ≥ 2 **or** histopathological grade 3 **or** age ≤ 35 **or** negative hormone receptor status
Descrição

Histopathological proof of axillary lymph node metastases (pN1-3) *or* high risk pN0/NX, defined as: pT ≥ 2 **or** histopathological grade 3 **or** age ≤ 35 **or** negative hormone receptor status

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C4687952
UMLS CUI [1,3]
C0686619
UMLS CUI [1,4]
C0729594
UMLS CUI [1,5]
C0332392
UMLS CUI [1,6]
C0332393
UMLS CUI [1,7]
C0332394
UMLS CUI [1,8]
C0475753
UMLS CUI [1,9]
C4272834
UMLS CUI [1,10]
C0001779
Complete resection the primary tumor with margins of resection free of invasive carcinoma not more than 6 weeks ago
Descrição

Complete resection the primary tumor with margins of resection free of invasive carcinoma not more than 6 weeks ago

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0728940
UMLS CUI [1,3]
C0475288
UMLS CUI [1,4]
C0332185
Females ≥ 18 years of age
Descrição

Females ≥ 18 years of age

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0001779
Performance Status ≤ 2 on ECOG-Scale
Descrição

Performance Status ≤ 2 on ECOG-Scale

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1520224
Adequate bone marrow reserve: leucocytes ≥ 3.0 x 109/l and platelets ≥ 100 x109/l
Descrição

Adequate bone marrow reserve: leucocytes ≥ 3.0 x 109/l and platelets ≥ 100 x109/l

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0032181
UMLS CUI [1,4]
C0023508
Bilirubin within one fold of the reference laboratory normal range, ASAT (SGOT), ALAT (SGPT) and AP within 1,5 fold of the reference laboratory normal range for patients t
Descrição

Bilirubin within one fold of the reference laboratory normal range, ASAT (SGOT), ALAT (SGPT) and AP within 1,5 fold of the reference laboratory normal range for patients t

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0201913
UMLS CUI [1,3]
C0201899
UMLS CUI [1,4]
C0201836
UMLS CUI [1,5]
C0201850
Intention of regular follow-up visits for the duration of the study
Descrição

Intention of regular follow-up visits for the duration of the study

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0162425
UMLS CUI [1,3]
C1522577
UMLS CUI [1,4]
C1512346
Ability to understand the nature of the study and to give written informed Consent <ol start="10">
Descrição

Ability to understand the nature of the study and to give written informed Consent <ol start="10">

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0021430
Patients will be *excluded* from the study for *any* of the following reasons:Inflammatory breast cancer
Descrição

Patients will be *excluded* from the study for *any* of the following reasons:Inflammatory breast cancer

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
Previous or concomitant cytotoxic or other systemic antineoplastic treatment which is not part of or allowed within this study
Descrição

Previous or concomitant cytotoxic or other systemic antineoplastic treatment which is not part of or allowed within this study

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0920425
UMLS CUI [1,3]
C0003392
UMLS CUI [1,4]
C0205156
UMLS CUI [1,5]
C0521115
History of treatment or disease affecting bone metabolism (e.g. Paget disease, primary hyperparathyroidism)
Descrição

History of treatment or disease affecting bone metabolism (e.g. Paget disease, primary hyperparathyroidism)

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1513041
UMLS CUI [1,4]
C0392760
UMLS CUI [1,5]
C0596204
Prior treatment with bisphosphonates within the last 6 months
Descrição

Prior treatment with bisphosphonates within the last 6 months

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0012544
UMLS CUI [1,4]
C3828652
Severe renal insufficiency as evidenced by creatinine clearance < 30 ml/min as calculated using the Cockcroft-Gault formula:
Descrição

Severe renal insufficiency as evidenced by creatinine clearance < 30 ml/min as calculated using the Cockcroft-Gault formula:

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1565489
UMLS CUI [1,3]
C0205082
UMLS CUI [1,4]
C2711451
Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
Descrição

Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0751623
UMLS CUI [1,3]
C1705847
UMLS CUI [1,4]
C0007117
UMLS CUI [1,5]
C0851140
UMLS CUI [1,6]
C0087111
Cardiomyopathy with impaired ventricular function (NYHA > II), cardiac arrythmias influencing LVEF and requiring medication, history of myocardial infarction or angina pectoris within the last 6 months, or arterial hypertension not being controlled by medication
Descrição

Cardiomyopathy with impaired ventricular function (NYHA > II), cardiac arrythmias influencing LVEF and requiring medication, history of myocardial infarction or angina pectoris within the last 6 months, or arterial hypertension not being controlled by medication

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0878544
UMLS CUI [1,3]
C4280733
UMLS CUI [1,4]
C0003811
UMLS CUI [1,5]
C3837267
UMLS CUI [1,6]
C0278961
UMLS CUI [1,7]
C1275835
UMLS CUI [1,8]
C0455530
UMLS CUI [1,9]
C3828652
UMLS CUI [1,10]
C0857354
infarction or angina pectoris within the last 6 months, or arterial hypertension not being controlled by medication
Descrição

infarction or angina pectoris within the last 6 months, or arterial hypertension not being controlled by medication

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0027051
UMLS CUI [1,3]
C0002962
UMLS CUI [1,4]
C3828652
UMLS CUI [1,5]
C0857354
Use of any investigational agent within 3 weeks prior to inclusion
Descrição

Use of any investigational agent within 3 weeks prior to inclusion

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0013230
UMLS CUI [1,4]
C1442462
UMLS CUI [1,5]
C0332152
UMLS CUI [1,6]
C1516879
Patients in pregnancy or breast feeding (in premenopausal women anticonception has to be assured: intra uterine devices, surgical methods of sterilization, or, in hormone unsensitive tumors only, oral, subcutaneous or transvaginal hormonal, non estrogen containing contraceptives)
Descrição

Patients in pregnancy or breast feeding (in premenopausal women anticonception has to be assured: intra uterine devices, surgical methods of sterilization, or, in hormone unsensitive tumors only, oral, subcutaneous or transvaginal hormonal, non estrogen containing contraceptives)

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0032961
UMLS CUI [1,3]
C0006147
UMLS CUI [2,1]
C0279752
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C4318577
Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
Descrição

Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C4518294
UMLS CUI [1,3]
C2168547
UMLS CUI [1,4]
C1301685
UMLS CUI [1,5]
C2711248
UMLS CUI [1,6]
C5200936
UMLS CUI [1,7]
C0011331
Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
Descrição

Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0204324
UMLS CUI [1,3]
C0407713
UMLS CUI [1,4]
C0332185
UMLS CUI [1,5]
C1301732
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Similar models

Eligibility Criteria

6 Formulários
  1. StudyEvent: SEV1
    1. Eligibility Criteria
    2. Subject ID, consent group, subject source, and subject source ID of participants with primary breast cancer and involved in the "Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial (SUCCESS-Trial)" project.
    3. Subject ID, family ID, father and mother IDs, and sex of participants with primary breast cancer and involved in the "Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial (SUCCESS-Trial)" project.
    4. Sample ID, subject ID, sample source, sample source ID, and sample use variables obtained from participants with primary breast cancer and involved in the "Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial (SUCCESS-Trial)" project.
    5. Subject ID, age, height, weight, tumor grade, tumor stage, histology of tumor, tumor ER, HER2, and PR status, menopause status, tumor progression and death of participants with primary breast cancer and involved in the "Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial (SUCCESS-Trial)" project.
    6. Sample ID, body site where sample was collected, analyte type of samples, tumor status, and histological type of samples obtained from participants with primary breast cancer and involved in the "Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial (SUCCESS-Trial)" project.
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Inclusion and exclusion criteria
Patients may be *included* in the study only if they meet *all* the following criteria:
Item
Patients may be *included* in the study only if they meet *all* the following criteria:
boolean
C1512693 (UMLS CUI [1,1])
Primary epithelial invasive carcinoma of the breast pT1-4, pM0
Item
Primary epithelial invasive carcinoma of the breast pT1-4, pM0
boolean
C1512693 (UMLS CUI [1,1])
C4076461 (UMLS CUI [1,2])
Histopathological proof of axillary lymph node metastases (pN1-3) *or* high risk pN0/NX, defined as: pT ≥ 2 **or** histopathological grade 3 **or** age ≤ 35 **or** negative hormone receptor status
Item
Histopathological proof of axillary lymph node metastases (pN1-3) *or* high risk pN0/NX, defined as: pT ≥ 2 **or** histopathological grade 3 **or** age ≤ 35 **or** negative hormone receptor status
boolean
C1512693 (UMLS CUI [1,1])
C4687952 (UMLS CUI [1,2])
C0686619 (UMLS CUI [1,3])
C0729594 (UMLS CUI [1,4])
C0332392 (UMLS CUI [1,5])
C0332393 (UMLS CUI [1,6])
C0332394 (UMLS CUI [1,7])
C0475753 (UMLS CUI [1,8])
C4272834 (UMLS CUI [1,9])
C0001779 (UMLS CUI [1,10])
Complete resection the primary tumor with margins of resection free of invasive carcinoma not more than 6 weeks ago
Item
Complete resection the primary tumor with margins of resection free of invasive carcinoma not more than 6 weeks ago
boolean
C1512693 (UMLS CUI [1,1])
C0728940 (UMLS CUI [1,2])
C0475288 (UMLS CUI [1,3])
C0332185 (UMLS CUI [1,4])
Females ≥ 18 years of age
Item
Females ≥ 18 years of age
boolean
C1512693 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
Performance Status ≤ 2 on ECOG-Scale
Item
Performance Status ≤ 2 on ECOG-Scale
boolean
C1512693 (UMLS CUI [1,1])
C1520224 (UMLS CUI [1,2])
Adequate bone marrow reserve: leucocytes ≥ 3.0 x 109/l and platelets ≥ 100 x109/l
Item
Adequate bone marrow reserve: leucocytes ≥ 3.0 x 109/l and platelets ≥ 100 x109/l
boolean
C1512693 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0032181 (UMLS CUI [1,3])
C0023508 (UMLS CUI [1,4])
Bilirubin within one fold of the reference laboratory normal range, ASAT (SGOT), ALAT (SGPT) and AP within 1,5 fold of the reference laboratory normal range for patients t
Item
Bilirubin within one fold of the reference laboratory normal range, ASAT (SGOT), ALAT (SGPT) and AP within 1,5 fold of the reference laboratory normal range for patients t
boolean
C1512693 (UMLS CUI [1,1])
C0201913 (UMLS CUI [1,2])
C0201899 (UMLS CUI [1,3])
C0201836 (UMLS CUI [1,4])
C0201850 (UMLS CUI [1,5])
Intention of regular follow-up visits for the duration of the study
Item
Intention of regular follow-up visits for the duration of the study
boolean
C1512693 (UMLS CUI [1,1])
C0162425 (UMLS CUI [1,2])
C1522577 (UMLS CUI [1,3])
C1512346 (UMLS CUI [1,4])
Ability to understand the nature of the study and to give written informed Consent <ol start="10">
Item
Ability to understand the nature of the study and to give written informed Consent <ol start="10">
boolean
C1512693 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Patients will be *excluded* from the study for *any* of the following reasons:Inflammatory breast cancer
Item
Patients will be *excluded* from the study for *any* of the following reasons:Inflammatory breast cancer
boolean
C0680251 (UMLS CUI [1,1])
Previous or concomitant cytotoxic or other systemic antineoplastic treatment which is not part of or allowed within this study
Item
Previous or concomitant cytotoxic or other systemic antineoplastic treatment which is not part of or allowed within this study
boolean
C0680251 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0003392 (UMLS CUI [1,3])
C0205156 (UMLS CUI [1,4])
C0521115 (UMLS CUI [1,5])
History of treatment or disease affecting bone metabolism (e.g. Paget disease, primary hyperparathyroidism)
Item
History of treatment or disease affecting bone metabolism (e.g. Paget disease, primary hyperparathyroidism)
boolean
C0680251 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1513041 (UMLS CUI [1,3])
C0392760 (UMLS CUI [1,4])
C0596204 (UMLS CUI [1,5])
Prior treatment with bisphosphonates within the last 6 months
Item
Prior treatment with bisphosphonates within the last 6 months
boolean
C0680251 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0012544 (UMLS CUI [1,3])
C3828652 (UMLS CUI [1,4])
Severe renal insufficiency as evidenced by creatinine clearance < 30 ml/min as calculated using the Cockcroft-Gault formula:
Item
Severe renal insufficiency as evidenced by creatinine clearance < 30 ml/min as calculated using the Cockcroft-Gault formula:
boolean
C0680251 (UMLS CUI [1,1])
C1565489 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C2711451 (UMLS CUI [1,4])
Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
Item
Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
boolean
C0680251 (UMLS CUI [1,1])
C0751623 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0007117 (UMLS CUI [1,4])
C0851140 (UMLS CUI [1,5])
C0087111 (UMLS CUI [1,6])
Cardiomyopathy with impaired ventricular function (NYHA > II), cardiac arrythmias influencing LVEF and requiring medication, history of myocardial infarction or angina pectoris within the last 6 months, or arterial hypertension not being controlled by medication
Item
Cardiomyopathy with impaired ventricular function (NYHA > II), cardiac arrythmias influencing LVEF and requiring medication, history of myocardial infarction or angina pectoris within the last 6 months, or arterial hypertension not being controlled by medication
boolean
C0680251 (UMLS CUI [1,1])
C0878544 (UMLS CUI [1,2])
C4280733 (UMLS CUI [1,3])
C0003811 (UMLS CUI [1,4])
C3837267 (UMLS CUI [1,5])
C0278961 (UMLS CUI [1,6])
C1275835 (UMLS CUI [1,7])
C0455530 (UMLS CUI [1,8])
C3828652 (UMLS CUI [1,9])
C0857354 (UMLS CUI [1,10])
infarction or angina pectoris within the last 6 months, or arterial hypertension not being controlled by medication
Item
infarction or angina pectoris within the last 6 months, or arterial hypertension not being controlled by medication
boolean
C0680251 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
C0002962 (UMLS CUI [1,3])
C3828652 (UMLS CUI [1,4])
C0857354 (UMLS CUI [1,5])
Use of any investigational agent within 3 weeks prior to inclusion
Item
Use of any investigational agent within 3 weeks prior to inclusion
boolean
C0680251 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C1442462 (UMLS CUI [1,4])
C0332152 (UMLS CUI [1,5])
C1516879 (UMLS CUI [1,6])
Patients in pregnancy or breast feeding (in premenopausal women anticonception has to be assured: intra uterine devices, surgical methods of sterilization, or, in hormone unsensitive tumors only, oral, subcutaneous or transvaginal hormonal, non estrogen containing contraceptives)
Item
Patients in pregnancy or breast feeding (in premenopausal women anticonception has to be assured: intra uterine devices, surgical methods of sterilization, or, in hormone unsensitive tumors only, oral, subcutaneous or transvaginal hormonal, non estrogen containing contraceptives)
boolean
C0680251 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,3])
C0279752 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C4318577 (UMLS CUI [2,3])
Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
Item
Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
boolean
C0680251 (UMLS CUI [1,1])
C4518294 (UMLS CUI [1,2])
C2168547 (UMLS CUI [1,3])
C1301685 (UMLS CUI [1,4])
C2711248 (UMLS CUI [1,5])
C5200936 (UMLS CUI [1,6])
C0011331 (UMLS CUI [1,7])
Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
Item
Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
boolean
C0680251 (UMLS CUI [1,1])
C0204324 (UMLS CUI [1,2])
C0407713 (UMLS CUI [1,3])
C0332185 (UMLS CUI [1,4])
C1301732 (UMLS CUI [1,5])
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