ID

39598

Description

A Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS); ODM derived from: https://clinicaltrials.gov/show/NCT01824836

Link

https://clinicaltrials.gov/show/NCT01824836

Keywords

Versions (1)
  1. 2/2/20 2/2/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 2, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Estrogen Receptor-positive Breast Cancer NCT01824836

English

Eligibility Estrogen Receptor-positive Breast Cancer NCT01824836

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must be post-menopausal; post-menopausal will be defined as women meeting any of the following criteria:
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
>= 60 years of age; or
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
< 60 years of age and amenorrheic for >= 12 months prior to day 1 if uterus/ovaries are intact; or
Description

Age | Amenorrhea Duration | Uterus Intact | Both ovaries Intact

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0449238
UMLS CUI [3,1]
C0042149
UMLS CUI [3,2]
C0205266
UMLS CUI [4,1]
C0227898
UMLS CUI [4,2]
C0205266
< 60 years of age, and the last menstrual period 6-12 months prior to day 1, if intact uterus/ovaries and meets biochemical criteria for menopause (follicle-stimulating hormone [fsh] and estradiol within institutional standard for postmenopausal status); or
Description

Age | Last menstrual period Recent | Uterus Intact | Both ovaries Intact | Criteria Fulfill Menopause | Follicle stimulating hormone measurement Postmenopausal state | Estradiol measurement Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0425932
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C0042149
UMLS CUI [3,2]
C0205266
UMLS CUI [4,1]
C0227898
UMLS CUI [4,2]
C0205266
UMLS CUI [5,1]
C0243161
UMLS CUI [5,2]
C1550543
UMLS CUI [5,3]
C0025320
UMLS CUI [6,1]
C0202022
UMLS CUI [6,2]
C0232970
UMLS CUI [7,1]
C0337434
UMLS CUI [7,2]
C0232970
< 60 years of age, without a uterus, and meets biochemical criteria for menopause (fsh and estradiol within institutional standards for postmenopausal status); or
Description

Age | Uterus Absent | Criteria Fulfill Menopause | Follicle stimulating hormone measurement Postmenopausal state | Estradiol measurement Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0042149
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0243161
UMLS CUI [3,2]
C1550543
UMLS CUI [3,3]
C0025320
UMLS CUI [4,1]
C0202022
UMLS CUI [4,2]
C0232970
UMLS CUI [5,1]
C0337434
UMLS CUI [5,2]
C0232970
< 60 years of age and history of bilateral oophorectomy; surgery must have been completed at least 4 weeks prior to day 1; or
Description

Age | Bilateral oophorectomy

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0278321
prior radiation castration with amenorrhea for at least 6 months
Description

Radiation castration | Amenorrhea Duration

Data type

boolean

Alias
UMLS CUI [1]
C0877129
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0449238
patients must have estrogen and/or progesterone receptor positive histologically confirmed stage i-iii adenocarcinoma of the breast
Description

Breast adenocarcinoma Estrogen receptor positive TNM Breast tumor staging | Breast adenocarcinoma Progesterone receptor positive TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0279754
UMLS CUI [1,3]
C0474926
UMLS CUI [2,1]
C0858252
UMLS CUI [2,2]
C0279759
UMLS CUI [2,3]
C0474926
patients must have completed recommended local therapy and adjuvant chemotherapy for breast cancer
Description

Local Therapy Completed Breast Carcinoma | Adjuvant Chemotherapy Completed Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1517925
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C0085533
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C0678222
patients must not have received prior ai therapy with exemestane, letrozole, or anastrozole as adjuvant therapy or for prevention of breast cancer; prior tamoxifen as adjuvant therapy or for prevention is allowed
Description

Aromatase Inhibitors Absent Breast Carcinoma | Exemestane Absent | Letrozole Absent | Anastrozole Absent | Tamoxifen allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0593802
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C0851344
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0246421
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0290883
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0039286
UMLS CUI [5,2]
C0683607
plan to treat with anastrozole for at least 12 months
Description

Anastrozole Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0290883
UMLS CUI [1,2]
C1301732
eastern cooperative oncology group (ecog) performance status between 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patients must not be currently taking (or have taken in the past 6 months) ongoing, daily analgesic medication for active, chronic conditions (i.e., rheumatoid arthritis, carpal tunnel syndrome, tenosynovitis, systemic lupus erythematosus, gout, fibromyalgia, or severe osteoarthritis involving the hands, wrists, hips, knees, feet or ankles); (note: patients taking daily low dose aspirin are allowed to participate in this trial)
Description

Analgesics Absent Chronic condition | Rheumatoid Arthritis | Carpal Tunnel Syndrome | Tenosynovitis | Lupus Erythematosus, Systemic | Gout | Fibromyalgia | Osteoarthritis of the hand Severe | Osteoarthritis of wrist Severe | Osteoarthritis of hip Severe | Knee Osteoarthritis Severe | Primary osteoarthritis of foot Severe | Osteoarthritis of ankle Severe | Aspirin Low Dose allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C4315615
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0007286
UMLS CUI [4]
C0039520
UMLS CUI [5]
C0024141
UMLS CUI [6]
C0018099
UMLS CUI [7]
C0016053
UMLS CUI [8,1]
C0263746
UMLS CUI [8,2]
C0205082
UMLS CUI [9,1]
C0409955
UMLS CUI [9,2]
C0205082
UMLS CUI [10,1]
C0029410
UMLS CUI [10,2]
C0205082
UMLS CUI [11,1]
C0409959
UMLS CUI [11,2]
C0205082
UMLS CUI [12,1]
C3862550
UMLS CUI [12,2]
C0205082
UMLS CUI [13,1]
C0409931
UMLS CUI [13,2]
C0205082
UMLS CUI [14,1]
C2608320
UMLS CUI [14,2]
C0683607
patients must not have a prior history of deep vein thrombosis (dvt) or pulmonary embolism in the past 5 years
Description

Deep Vein Thrombosis Absent | Pulmonary Embolism Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0149871
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0034065
UMLS CUI [2,2]
C0332197
patients must have worst pain rated as less than 4 out of 10 on the following question: "in the past week, how much pain have you had on a scale of 0 to 10, where 0 equals no pain and 10 means the worst pain you can imagine; " note: this question regarding patient's pain should be completed within one week prior to registration; this pain item may be completed orally prior to consent up to 7 days prior to registration; it is not necessary to complete this pain item via the promis website
Description

Pain at its Worst Numeric Pain Scale

Data type

boolean

Alias
UMLS CUI [1,1]
C3642228
UMLS CUI [1,2]
C1518471
patients must have adequate hepatic, hematologic and renal functioning to be able to be administered anastrozole at the discretion of the treating physician
Description

Liver function | Hematologic function | Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0221130
UMLS CUI [3]
C0232804
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Similar models

Eligibility Estrogen Receptor-positive Breast Cancer NCT01824836

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state
Item
patients must be post-menopausal; post-menopausal will be defined as women meeting any of the following criteria:
boolean
C0232970 (UMLS CUI [1])
Age
Item
>= 60 years of age; or
boolean
C0001779 (UMLS CUI [1])
Age | Amenorrhea Duration | Uterus Intact | Both ovaries Intact
Item
< 60 years of age and amenorrheic for >= 12 months prior to day 1 if uterus/ovaries are intact; or
boolean
C0001779 (UMLS CUI [1])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0042149 (UMLS CUI [3,1])
C0205266 (UMLS CUI [3,2])
C0227898 (UMLS CUI [4,1])
C0205266 (UMLS CUI [4,2])
Age | Last menstrual period Recent | Uterus Intact | Both ovaries Intact | Criteria Fulfill Menopause | Follicle stimulating hormone measurement Postmenopausal state | Estradiol measurement Postmenopausal state
Item
< 60 years of age, and the last menstrual period 6-12 months prior to day 1, if intact uterus/ovaries and meets biochemical criteria for menopause (follicle-stimulating hormone [fsh] and estradiol within institutional standard for postmenopausal status); or
boolean
C0001779 (UMLS CUI [1])
C0425932 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0042149 (UMLS CUI [3,1])
C0205266 (UMLS CUI [3,2])
C0227898 (UMLS CUI [4,1])
C0205266 (UMLS CUI [4,2])
C0243161 (UMLS CUI [5,1])
C1550543 (UMLS CUI [5,2])
C0025320 (UMLS CUI [5,3])
C0202022 (UMLS CUI [6,1])
C0232970 (UMLS CUI [6,2])
C0337434 (UMLS CUI [7,1])
C0232970 (UMLS CUI [7,2])
Age | Uterus Absent | Criteria Fulfill Menopause | Follicle stimulating hormone measurement Postmenopausal state | Estradiol measurement Postmenopausal state
Item
< 60 years of age, without a uterus, and meets biochemical criteria for menopause (fsh and estradiol within institutional standards for postmenopausal status); or
boolean
C0001779 (UMLS CUI [1])
C0042149 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0243161 (UMLS CUI [3,1])
C1550543 (UMLS CUI [3,2])
C0025320 (UMLS CUI [3,3])
C0202022 (UMLS CUI [4,1])
C0232970 (UMLS CUI [4,2])
C0337434 (UMLS CUI [5,1])
C0232970 (UMLS CUI [5,2])
Age | Bilateral oophorectomy
Item
< 60 years of age and history of bilateral oophorectomy; surgery must have been completed at least 4 weeks prior to day 1; or
boolean
C0001779 (UMLS CUI [1])
C0278321 (UMLS CUI [2])
Radiation castration | Amenorrhea Duration
Item
prior radiation castration with amenorrhea for at least 6 months
boolean
C0877129 (UMLS CUI [1])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Breast adenocarcinoma Estrogen receptor positive TNM Breast tumor staging | Breast adenocarcinoma Progesterone receptor positive TNM Breast tumor staging
Item
patients must have estrogen and/or progesterone receptor positive histologically confirmed stage i-iii adenocarcinoma of the breast
boolean
C0858252 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
C0858252 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
C0474926 (UMLS CUI [2,3])
Local Therapy Completed Breast Carcinoma | Adjuvant Chemotherapy Completed Breast Carcinoma
Item
patients must have completed recommended local therapy and adjuvant chemotherapy for breast cancer
boolean
C1517925 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0085533 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
Aromatase Inhibitors Absent Breast Carcinoma | Exemestane Absent | Letrozole Absent | Anastrozole Absent | Tamoxifen allowed
Item
patients must not have received prior ai therapy with exemestane, letrozole, or anastrozole as adjuvant therapy or for prevention of breast cancer; prior tamoxifen as adjuvant therapy or for prevention is allowed
boolean
C0593802 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0851344 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0246421 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0290883 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0039286 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
Anastrozole Planned
Item
plan to treat with anastrozole for at least 12 months
boolean
C0290883 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status between 0-2
boolean
C1520224 (UMLS CUI [1])
Analgesics Absent Chronic condition | Rheumatoid Arthritis | Carpal Tunnel Syndrome | Tenosynovitis | Lupus Erythematosus, Systemic | Gout | Fibromyalgia | Osteoarthritis of the hand Severe | Osteoarthritis of wrist Severe | Osteoarthritis of hip Severe | Knee Osteoarthritis Severe | Primary osteoarthritis of foot Severe | Osteoarthritis of ankle Severe | Aspirin Low Dose allowed
Item
patients must not be currently taking (or have taken in the past 6 months) ongoing, daily analgesic medication for active, chronic conditions (i.e., rheumatoid arthritis, carpal tunnel syndrome, tenosynovitis, systemic lupus erythematosus, gout, fibromyalgia, or severe osteoarthritis involving the hands, wrists, hips, knees, feet or ankles); (note: patients taking daily low dose aspirin are allowed to participate in this trial)
boolean
C0002771 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C4315615 (UMLS CUI [1,3])
C0003873 (UMLS CUI [2])
C0007286 (UMLS CUI [3])
C0039520 (UMLS CUI [4])
C0024141 (UMLS CUI [5])
C0018099 (UMLS CUI [6])
C0016053 (UMLS CUI [7])
C0263746 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0409955 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C0029410 (UMLS CUI [10,1])
C0205082 (UMLS CUI [10,2])
C0409959 (UMLS CUI [11,1])
C0205082 (UMLS CUI [11,2])
C3862550 (UMLS CUI [12,1])
C0205082 (UMLS CUI [12,2])
C0409931 (UMLS CUI [13,1])
C0205082 (UMLS CUI [13,2])
C2608320 (UMLS CUI [14,1])
C0683607 (UMLS CUI [14,2])
Deep Vein Thrombosis Absent | Pulmonary Embolism Absent
Item
patients must not have a prior history of deep vein thrombosis (dvt) or pulmonary embolism in the past 5 years
boolean
C0149871 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0034065 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Pain at its Worst Numeric Pain Scale
Item
patients must have worst pain rated as less than 4 out of 10 on the following question: "in the past week, how much pain have you had on a scale of 0 to 10, where 0 equals no pain and 10 means the worst pain you can imagine; " note: this question regarding patient's pain should be completed within one week prior to registration; this pain item may be completed orally prior to consent up to 7 days prior to registration; it is not necessary to complete this pain item via the promis website
boolean
C3642228 (UMLS CUI [1,1])
C1518471 (UMLS CUI [1,2])
Liver function | Hematologic function | Renal function
Item
patients must have adequate hepatic, hematologic and renal functioning to be able to be administered anastrozole at the discretion of the treating physician
boolean
C0232741 (UMLS CUI [1])
C0221130 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
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