ID

37847

Description

Biomarkers in Blood Samples From Older Breast Cancer Survivors; ODM derived from: https://clinicaltrials.gov/show/NCT01138345

Link

https://clinicaltrials.gov/show/NCT01138345

Keywords

Versions (1)
  1. 8/27/19 8/27/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 27, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01138345

English

Eligibility Breast Cancer NCT01138345

1 forms  
Criteria
Description

Criteria

histologically confirmed breast cancer
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
stage i-iii disease
Description

Disease TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0474926
breast cancer survivors meeting 1 of the following criteria:
Description

Breast Carcinoma Survivors | Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0206194
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
prior surgery with or without (±) radiotherapy (rt) (cohort 1)
Description

Operative Surgical Procedures Previous | Therapeutic radiology procedure | Therapeutic radiology procedure Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C1522449
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0332197
prior surgery ± rt, followed by prior or concurrent hormonal (endocrine) therapy (cohort 2)
Description

Operative Surgical Procedures Previous | Therapeutic radiology procedure | Therapeutic radiology procedure Absent | Followed by Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C1522449
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0332283
UMLS CUI [4,2]
C0279025
must have received or be on endocrine therapy for ≥ 3 months
Description

Hormone Therapy Duration Required

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C1514873
prior surgery ± rt, followed by prior chemotherapy ± endocrine therapy (cohort 3)
Description

Operative Surgical Procedures Previous | Therapeutic radiology procedure | Therapeutic radiology procedure Absent | Followed by Prior Chemotherapy | Hormone Therapy | Hormone Therapy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C1522449
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0332283
UMLS CUI [4,2]
C1514457
UMLS CUI [5]
C0279025
UMLS CUI [6,1]
C0279025
UMLS CUI [6,2]
C0332197
no recurrent disease
Description

Recurrent disease Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0332197
no history of clonal bone marrow disorder (i.e., myelodysplastic or myeloproliferative disorder, acute or chronic leukemia)
Description

Bone Marrow Disease Clonal Absent | MYELODYSPLASTIC SYNDROME Absent | Myeloproliferative disease Absent | Acute leukemia Absent | Chronic leukemia Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0005956
UMLS CUI [1,2]
C1522642
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3463824
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0027022
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0085669
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C1279296
UMLS CUI [5,2]
C0332197
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
life expectancy > 12 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
absolute lymphocyte count > 500/μl
Description

Absolute lymphocyte count

Data type

boolean

Alias
UMLS CUI [1]
C3544087
no acute or active infection
Description

Communicable Disease Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0332197
no other co-morbid illness that would impair ability to participate in the study
Description

Absence Comorbidity Impairing Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0009488
UMLS CUI [1,3]
C0221099
UMLS CUI [1,4]
C2348568
prior concurrent therapy:
Description

Prior Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514463
see disease characteristics
Description

ID.16

Data type

boolean

at least 3 months since prior surgery with or without radiotherapy
Description

Operative Surgical Procedures Previous | Therapeutic radiology procedure | Therapeutic radiology procedure Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C1522449
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0332197
at least 3 months since prior chemotherapy (cohort 3)
Description

Prior Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
no concurrent radiotherapy, chemotherapy, or experimental therapy
Description

Therapeutic radiology procedure Concurrent Absent | Chemotherapy Concurrent Absent | Investigational Therapy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205420
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0205420
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0949266
UMLS CUI [3,2]
C0332197
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Similar models

Eligibility Breast Cancer NCT01138345

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Breast Carcinoma
Item
histologically confirmed breast cancer
boolean
C0678222 (UMLS CUI [1])
Disease TNM Breast tumor staging
Item
stage i-iii disease
boolean
C0012634 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Breast Carcinoma Survivors | Criteria Fulfill
Item
breast cancer survivors meeting 1 of the following criteria:
boolean
C0678222 (UMLS CUI [1,1])
C0206194 (UMLS CUI [1,2])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Operative Surgical Procedures Previous | Therapeutic radiology procedure | Therapeutic radiology procedure Absent
Item
prior surgery with or without (±) radiotherapy (rt) (cohort 1)
boolean
C0543467 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Operative Surgical Procedures Previous | Therapeutic radiology procedure | Therapeutic radiology procedure Absent | Followed by Hormone Therapy
Item
prior surgery ± rt, followed by prior or concurrent hormonal (endocrine) therapy (cohort 2)
boolean
C0543467 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0332283 (UMLS CUI [4,1])
C0279025 (UMLS CUI [4,2])
Hormone Therapy Duration Required
Item
must have received or be on endocrine therapy for ≥ 3 months
boolean
C0279025 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
Operative Surgical Procedures Previous | Therapeutic radiology procedure | Therapeutic radiology procedure Absent | Followed by Prior Chemotherapy | Hormone Therapy | Hormone Therapy Absent
Item
prior surgery ± rt, followed by prior chemotherapy ± endocrine therapy (cohort 3)
boolean
C0543467 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0332283 (UMLS CUI [4,1])
C1514457 (UMLS CUI [4,2])
C0279025 (UMLS CUI [5])
C0279025 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Recurrent disease Absent
Item
no recurrent disease
boolean
C0277556 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Bone Marrow Disease Clonal Absent | MYELODYSPLASTIC SYNDROME Absent | Myeloproliferative disease Absent | Acute leukemia Absent | Chronic leukemia Absent
Item
no history of clonal bone marrow disorder (i.e., myelodysplastic or myeloproliferative disorder, acute or chronic leukemia)
boolean
C0005956 (UMLS CUI [1,1])
C1522642 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3463824 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0027022 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0085669 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1279296 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 12 months
boolean
C0023671 (UMLS CUI [1])
Absolute lymphocyte count
Item
absolute lymphocyte count > 500/μl
boolean
C3544087 (UMLS CUI [1])
Communicable Disease Absent
Item
no acute or active infection
boolean
C0009450 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Absence Comorbidity Impairing Study Subject Participation Status
Item
no other co-morbid illness that would impair ability to participate in the study
boolean
C0332197 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0221099 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
Prior Therapy
Item
prior concurrent therapy:
boolean
C1514463 (UMLS CUI [1])
ID.16
Item
see disease characteristics
boolean
Operative Surgical Procedures Previous | Therapeutic radiology procedure | Therapeutic radiology procedure Absent
Item
at least 3 months since prior surgery with or without radiotherapy
boolean
C0543467 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Prior Chemotherapy
Item
at least 3 months since prior chemotherapy (cohort 3)
boolean
C1514457 (UMLS CUI [1])
Therapeutic radiology procedure Concurrent Absent | Chemotherapy Concurrent Absent | Investigational Therapy Absent
Item
no concurrent radiotherapy, chemotherapy, or experimental therapy
boolean
C1522449 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0205420 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0949266 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
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