ID

26220

Beskrivning

Rheumatological Evaluation of Anastrozole and Letrozole as Adjuvant Treatment in Post-menopausal Women With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00688909

Länk

https://clinicaltrials.gov/show/NCT00688909

Nyckelord

Versioner (1)
  1. 2017-10-11 2017-10-11 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

11 oktober 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00688909

Engelsk

Eligibility Breast Cancer NCT00688909

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. postmenopausal women with hr+ early stage breast cancer at the time of initial diagnosis. for study purposes, postmenopausal is defined as:
Beskrivning

Postmenopausal state | Early-Stage Breast Carcinoma Hormone Receptor Positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C2986665
UMLS CUI [2,2]
C0019929
UMLS CUI [2,3]
C1514241
age ≥ 50 y and amenorrheic for 12 or more months.
Beskrivning

Age | Amenorrhea Duration

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0449238
age ≥ 50 y and amenorrheic for 3 or more months after receiving adjuvant chemotherapy.
Beskrivning

Age | Amenorrhea Duration | Status post Adjuvant Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0449238
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0085533
age < 50 y and amenorrheic for 12 or more months.
Beskrivning

Age | Amenorrhea Duration

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0449238
prior bilateral oophorectomy.
Beskrivning

Bilateral oophorectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0278321
prior hysterectomy and has postmenopausal levels of fsh, lh, and estradiol as per local institutional standards.
Beskrivning

Hysterectomy | Follicle stimulating hormone measurement Postmenopausal state | Luteinizing hormone measurement Postmenopausal state | Estradiol measurement Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0020699
UMLS CUI [2,1]
C0202022
UMLS CUI [2,2]
C0232970
UMLS CUI [3,1]
C0202123
UMLS CUI [3,2]
C0232970
UMLS CUI [4,1]
C0337434
UMLS CUI [4,2]
C0232970
age > 55 y and prior hysterectomy.
Beskrivning

Age | Hysterectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0020699
2. patients who are intolerant and discontinue anastrozole 2-3 weeks prior to study entry when given as adjuvant treatment for hr+ early stage breast cancer due to grade 2-3 (nci-ctcae v3) arthralgia-myalgia.
Beskrivning

Intolerance to Anastrozole | Anastrozole Discontinue | Adjuvant therapy Early-Stage Breast Carcinoma Hormone Receptor Positive | Arthralgia CTCAE Grades | Myalgia CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0290883
UMLS CUI [2,1]
C0290883
UMLS CUI [2,2]
C1444662
UMLS CUI [3,1]
C0677850
UMLS CUI [3,2]
C2986665
UMLS CUI [3,3]
C0019929
UMLS CUI [3,4]
C1514241
UMLS CUI [4,1]
C0003862
UMLS CUI [4,2]
C1516728
UMLS CUI [5,1]
C0231528
UMLS CUI [5,2]
C1516728
3. hormone receptor-positive tumors as defined by institutional standards.
Beskrivning

Hormone receptor positive tumor

Datatyp

boolean

Alias
UMLS CUI [1]
C1563119
4. ecog performance status of 0, 1, or 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
5. consent to participate in the trial. -
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. postmenopausal women with hr+ metastatic or locally relapsed breast cancer excluding chest wall recurrence with no evidence of systemic disease.
Beskrivning

Postmenopausal state | Secondary malignant neoplasm of female breast Hormone Receptor Positive | Breast cancer recurrent Locally | Exception Chest wall Disease recurrence | Systemic disease Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C0346993
UMLS CUI [2,2]
C0019929
UMLS CUI [2,3]
C1514241
UMLS CUI [3,1]
C0278493
UMLS CUI [3,2]
C1517927
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0205076
UMLS CUI [4,3]
C0679254
UMLS CUI [5,1]
C0442893
UMLS CUI [5,2]
C0332197
2. recent history of pain associated with non-traumatic bone fracture.
Beskrivning

Pain Associated with Bone Fracture

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0016658
3. pain requiring chronic use of analgesics (due to any reason).
Beskrivning

Pain Requirement Analgesics chronic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0002771
UMLS CUI [1,4]
C0205191
4. history of rheumatological disease except osteoarthritis.
Beskrivning

Collagen Disease | Exception Osteoarthritis

Datatyp

boolean

Alias
UMLS CUI [1]
C0009326
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0029408
5. prior hormonal therapy with ais other than anastrozole.
Beskrivning

Hormone Therapy | Aromatase Inhibitors | Exception Anastrozole

Datatyp

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2]
C0593802
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0290883
6. systemic hormone replacement therapy (hrt) less than 4 weeks before study entry other than estring®, vagifem® or low dose estrogen vaginal cream.
Beskrivning

Hormone replacement therapy Systemic | Exception Estring | Exception Vagifem | Exception Vaginal estrogens Low dose

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0282402
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0591465
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0592238
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1875126
UMLS CUI [4,3]
C0445550
7. concomitant disease which significantly affects quality of life.
Beskrivning

Comorbidity Affecting Quality of life

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0034380
8. patient unable to complete self administered questionnaire.
Beskrivning

Questionnaire Self-Administered Completion Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C1519231
UMLS CUI [1,3]
C0205197
UMLS CUI [1,4]
C1299582
9. patients unable to sign consent form.
Beskrivning

Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
other protocol-defined inclusion/exclusion criteria may apply
Beskrivning

Clinical Trial Eligibility Criteria Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Breast Cancer NCT00688909

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state | Early-Stage Breast Carcinoma Hormone Receptor Positive
Item
1. postmenopausal women with hr+ early stage breast cancer at the time of initial diagnosis. for study purposes, postmenopausal is defined as:
boolean
C0232970 (UMLS CUI [1])
C2986665 (UMLS CUI [2,1])
C0019929 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
Age | Amenorrhea Duration
Item
age ≥ 50 y and amenorrheic for 12 or more months.
boolean
C0001779 (UMLS CUI [1])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Age | Amenorrhea Duration | Status post Adjuvant Chemotherapy
Item
age ≥ 50 y and amenorrheic for 3 or more months after receiving adjuvant chemotherapy.
boolean
C0001779 (UMLS CUI [1])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0085533 (UMLS CUI [3,2])
Age | Amenorrhea Duration
Item
age < 50 y and amenorrheic for 12 or more months.
boolean
C0001779 (UMLS CUI [1])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Bilateral oophorectomy
Item
prior bilateral oophorectomy.
boolean
C0278321 (UMLS CUI [1])
Hysterectomy | Follicle stimulating hormone measurement Postmenopausal state | Luteinizing hormone measurement Postmenopausal state | Estradiol measurement Postmenopausal state
Item
prior hysterectomy and has postmenopausal levels of fsh, lh, and estradiol as per local institutional standards.
boolean
C0020699 (UMLS CUI [1])
C0202022 (UMLS CUI [2,1])
C0232970 (UMLS CUI [2,2])
C0202123 (UMLS CUI [3,1])
C0232970 (UMLS CUI [3,2])
C0337434 (UMLS CUI [4,1])
C0232970 (UMLS CUI [4,2])
Age | Hysterectomy
Item
age > 55 y and prior hysterectomy.
boolean
C0001779 (UMLS CUI [1])
C0020699 (UMLS CUI [2])
Intolerance to Anastrozole | Anastrozole Discontinue | Adjuvant therapy Early-Stage Breast Carcinoma Hormone Receptor Positive | Arthralgia CTCAE Grades | Myalgia CTCAE Grades
Item
2. patients who are intolerant and discontinue anastrozole 2-3 weeks prior to study entry when given as adjuvant treatment for hr+ early stage breast cancer due to grade 2-3 (nci-ctcae v3) arthralgia-myalgia.
boolean
C1744706 (UMLS CUI [1,1])
C0290883 (UMLS CUI [1,2])
C0290883 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0677850 (UMLS CUI [3,1])
C2986665 (UMLS CUI [3,2])
C0019929 (UMLS CUI [3,3])
C1514241 (UMLS CUI [3,4])
C0003862 (UMLS CUI [4,1])
C1516728 (UMLS CUI [4,2])
C0231528 (UMLS CUI [5,1])
C1516728 (UMLS CUI [5,2])
Hormone receptor positive tumor
Item
3. hormone receptor-positive tumors as defined by institutional standards.
boolean
C1563119 (UMLS CUI [1])
ECOG performance status
Item
4. ecog performance status of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
5. consent to participate in the trial. -
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Postmenopausal state | Secondary malignant neoplasm of female breast Hormone Receptor Positive | Breast cancer recurrent Locally | Exception Chest wall Disease recurrence | Systemic disease Absent
Item
1. postmenopausal women with hr+ metastatic or locally relapsed breast cancer excluding chest wall recurrence with no evidence of systemic disease.
boolean
C0232970 (UMLS CUI [1])
C0346993 (UMLS CUI [2,1])
C0019929 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
C0278493 (UMLS CUI [3,1])
C1517927 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0205076 (UMLS CUI [4,2])
C0679254 (UMLS CUI [4,3])
C0442893 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Pain Associated with Bone Fracture
Item
2. recent history of pain associated with non-traumatic bone fracture.
boolean
C0030193 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0016658 (UMLS CUI [1,3])
Pain Requirement Analgesics chronic
Item
3. pain requiring chronic use of analgesics (due to any reason).
boolean
C0030193 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0002771 (UMLS CUI [1,3])
C0205191 (UMLS CUI [1,4])
Collagen Disease | Exception Osteoarthritis
Item
4. history of rheumatological disease except osteoarthritis.
boolean
C0009326 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0029408 (UMLS CUI [2,2])
Hormone Therapy | Aromatase Inhibitors | Exception Anastrozole
Item
5. prior hormonal therapy with ais other than anastrozole.
boolean
C0279025 (UMLS CUI [1])
C0593802 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0290883 (UMLS CUI [3,2])
Hormone replacement therapy Systemic | Exception Estring | Exception Vagifem | Exception Vaginal estrogens Low dose
Item
6. systemic hormone replacement therapy (hrt) less than 4 weeks before study entry other than estring®, vagifem® or low dose estrogen vaginal cream.
boolean
C0282402 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0591465 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0592238 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1875126 (UMLS CUI [4,2])
C0445550 (UMLS CUI [4,3])
Comorbidity Affecting Quality of life
Item
7. concomitant disease which significantly affects quality of life.
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0034380 (UMLS CUI [1,3])
Questionnaire Self-Administered Completion Unable
Item
8. patient unable to complete self administered questionnaire.
boolean
C0034394 (UMLS CUI [1,1])
C1519231 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Informed Consent Unable
Item
9. patients unable to sign consent form.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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