ID

37932

Beskrivning

Oral Health and Oral Health-Related Quality of Life in Early Stage Breast Cancer Survivors; ODM derived from: https://clinicaltrials.gov/show/NCT01272570

Länk

https://clinicaltrials.gov/show/NCT01272570

Nyckelord

Versioner (1)
  1. 2019-09-01 2019-09-01 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

1 september 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01272570

Engelsk

Eligibility Breast Cancer NCT01272570

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal as defined by nccn (any of the following)
Beskrivning

Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
prior bilateral oophorectomy
Beskrivning

Bilateral oophorectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0278321
age equal to or greater then 60 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
age less then 60 and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene or ovarian suppression and fsh and estradiol in the postmenopausal range
Beskrivning

Age | Amenorrhea Duration | Chemotherapy Absent | Tamoxifen Absent | Toremifene Absent | Ovarian suppression Absent | FSH measurement in range Postmenopausal state | Estradiol measurement in range Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0449238
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0039286
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0076836
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0677922
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C0202022
UMLS CUI [7,2]
C0460094
UMLS CUI [7,3]
C0232970
UMLS CUI [8,1]
C0337434
UMLS CUI [8,2]
C0460094
UMLS CUI [8,3]
C0232970
if taking tamoxifen or toremifene and age less then 60y, then fsh and plasma estradiol level in postmenopausal ranges71.
Beskrivning

Tamoxifen | Toremifene | Age | FSH measurement in range Postmenopausal state | Plasma estradiol measurement in range Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0039286
UMLS CUI [2]
C0076836
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C0202022
UMLS CUI [4,2]
C0460094
UMLS CUI [4,3]
C0232970
UMLS CUI [5,1]
C1277973
UMLS CUI [5,2]
C0460094
UMLS CUI [5,3]
C0232970
individuals capable of consenting and self administering the survey instrument.
Beskrivning

Capability Informed Consent | Survey instrument Completion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2698977
UMLS CUI [1,2]
C0021430
UMLS CUI [2,1]
C0038951
UMLS CUI [2,2]
C0205197
at least 15 teeth present.
Beskrivning

Teeth Quantity Present

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040426
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0150312
ai users:
Beskrivning

Aromatase Inhibitors Use

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0593802
UMLS CUI [1,2]
C0457083
diagnosis of bca- histologic confirmed diagnosis of bca: stage 0, i, ii, or iii with no evidence of metastatic disease.
Beskrivning

Breast Carcinoma TNM Breast tumor staging | Neoplasm Metastasis Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0332197
treatment- ai as clinically indicated (ai may be anastrozole, exemestane or letrozole). subjects may have had prior tamoxifen or raloxifene. subjects may have had chemotherapy and/or radiation therapy. must be within the first year of consecutive ai therapy. if a subject started ai, discontinued, then restarted, they will be accepted into the study as long as the past therapy did not exceed 12 months and the current therapy has not exceeded 12 months.
Beskrivning

Indication Aromatase Inhibitors | anastrozole | exemestane | letrozole | Tamoxifen | Raloxifene | Chemotherapy | Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0593802
UMLS CUI [2]
C0290883
UMLS CUI [3]
C0851344
UMLS CUI [4]
C0246421
UMLS CUI [5]
C0039286
UMLS CUI [6]
C0244404
UMLS CUI [7]
C0392920
UMLS CUI [8]
C1522449
controls:
Beskrivning

Control Group

Datatyp

boolean

Alias
UMLS CUI [1]
C0009932
no diagnosis of cancer.- patients must not have a diagnosis of any cancer (not including a history of thyroid or skin cancer).
Beskrivning

Malignant Neoplasm Absent | Exception Malignant neoplasm of thyroid | Exception Skin carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007115
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
metastatic bca (ai treated group: fully resected locally recurrent disease is permitted if the patient has been rendered without evidence of disease).
Beskrivning

Secondary malignant neoplasm of female breast

Datatyp

boolean

Alias
UMLS CUI [1]
C0346993
significant psychiatric illness/social situations that would preclude completion of questionnaires
Beskrivning

Mental disorders Exclude Completion Questionnaires | Social situation Excludes Completion Questionnaires

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0205197
UMLS CUI [1,4]
C0034394
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0205197
UMLS CUI [2,4]
C0034394
chronic medications known to affect the periodontal status (calcium antagonist, anti-convulsives, immunosuppressives (> prednisone 7.5mg daily). nsaids and bisphosphonates are permitted.
Beskrivning

Pharmaceutical Preparations chronic Affecting Periodontal Index | Calcium Channel Blockers | Anticonvulsants | Immunosuppressive Agents | Prednisone U/day | NSAIDs allowed | Diphosphonates allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0031092
UMLS CUI [2]
C0006684
UMLS CUI [3]
C0003286
UMLS CUI [4]
C0021081
UMLS CUI [5,1]
C0032952
UMLS CUI [5,2]
C0456683
UMLS CUI [6,1]
C0003211
UMLS CUI [6,2]
C0683607
UMLS CUI [7,1]
C0012544
UMLS CUI [7,2]
C0683607
premedication- conditions that require antibiotic therapy will be evaluated on a case-by-case basis. (patients taking prophylaxis for joint replacements will not be excluded.)
Beskrivning

Premedication Condition Requirement Antibiotic therapy | Evaluation Special

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033045
UMLS CUI [1,2]
C0348080
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0338237
UMLS CUI [2,1]
C1261322
UMLS CUI [2,2]
C0205555
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Similar models

Eligibility Breast Cancer NCT01272570

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state
Item
postmenopausal as defined by nccn (any of the following)
boolean
C0232970 (UMLS CUI [1])
Bilateral oophorectomy
Item
prior bilateral oophorectomy
boolean
C0278321 (UMLS CUI [1])
Age
Item
age equal to or greater then 60 years of age
boolean
C0001779 (UMLS CUI [1])
Age | Amenorrhea Duration | Chemotherapy Absent | Tamoxifen Absent | Toremifene Absent | Ovarian suppression Absent | FSH measurement in range Postmenopausal state | Estradiol measurement in range Postmenopausal state
Item
age less then 60 and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene or ovarian suppression and fsh and estradiol in the postmenopausal range
boolean
C0001779 (UMLS CUI [1])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0039286 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0076836 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0677922 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0202022 (UMLS CUI [7,1])
C0460094 (UMLS CUI [7,2])
C0232970 (UMLS CUI [7,3])
C0337434 (UMLS CUI [8,1])
C0460094 (UMLS CUI [8,2])
C0232970 (UMLS CUI [8,3])
Tamoxifen | Toremifene | Age | FSH measurement in range Postmenopausal state | Plasma estradiol measurement in range Postmenopausal state
Item
if taking tamoxifen or toremifene and age less then 60y, then fsh and plasma estradiol level in postmenopausal ranges71.
boolean
C0039286 (UMLS CUI [1])
C0076836 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0202022 (UMLS CUI [4,1])
C0460094 (UMLS CUI [4,2])
C0232970 (UMLS CUI [4,3])
C1277973 (UMLS CUI [5,1])
C0460094 (UMLS CUI [5,2])
C0232970 (UMLS CUI [5,3])
Capability Informed Consent | Survey instrument Completion
Item
individuals capable of consenting and self administering the survey instrument.
boolean
C2698977 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0038951 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Teeth Quantity Present
Item
at least 15 teeth present.
boolean
C0040426 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,3])
Aromatase Inhibitors Use
Item
ai users:
boolean
C0593802 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
Breast Carcinoma TNM Breast tumor staging | Neoplasm Metastasis Absent
Item
diagnosis of bca- histologic confirmed diagnosis of bca: stage 0, i, ii, or iii with no evidence of metastatic disease.
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Indication Aromatase Inhibitors | anastrozole | exemestane | letrozole | Tamoxifen | Raloxifene | Chemotherapy | Therapeutic radiology procedure
Item
treatment- ai as clinically indicated (ai may be anastrozole, exemestane or letrozole). subjects may have had prior tamoxifen or raloxifene. subjects may have had chemotherapy and/or radiation therapy. must be within the first year of consecutive ai therapy. if a subject started ai, discontinued, then restarted, they will be accepted into the study as long as the past therapy did not exceed 12 months and the current therapy has not exceeded 12 months.
boolean
C3146298 (UMLS CUI [1,1])
C0593802 (UMLS CUI [1,2])
C0290883 (UMLS CUI [2])
C0851344 (UMLS CUI [3])
C0246421 (UMLS CUI [4])
C0039286 (UMLS CUI [5])
C0244404 (UMLS CUI [6])
C0392920 (UMLS CUI [7])
C1522449 (UMLS CUI [8])
Control Group
Item
controls:
boolean
C0009932 (UMLS CUI [1])
Malignant Neoplasm Absent | Exception Malignant neoplasm of thyroid | Exception Skin carcinoma
Item
no diagnosis of cancer.- patients must not have a diagnosis of any cancer (not including a history of thyroid or skin cancer).
boolean
C0006826 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007115 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Secondary malignant neoplasm of female breast
Item
metastatic bca (ai treated group: fully resected locally recurrent disease is permitted if the patient has been rendered without evidence of disease).
boolean
C0346993 (UMLS CUI [1])
Mental disorders Exclude Completion Questionnaires | Social situation Excludes Completion Questionnaires
Item
significant psychiatric illness/social situations that would preclude completion of questionnaires
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0034394 (UMLS CUI [1,4])
C0748872 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C0034394 (UMLS CUI [2,4])
Pharmaceutical Preparations chronic Affecting Periodontal Index | Calcium Channel Blockers | Anticonvulsants | Immunosuppressive Agents | Prednisone U/day | NSAIDs allowed | Diphosphonates allowed
Item
chronic medications known to affect the periodontal status (calcium antagonist, anti-convulsives, immunosuppressives (> prednisone 7.5mg daily). nsaids and bisphosphonates are permitted.
boolean
C0013227 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0031092 (UMLS CUI [1,4])
C0006684 (UMLS CUI [2])
C0003286 (UMLS CUI [3])
C0021081 (UMLS CUI [4])
C0032952 (UMLS CUI [5,1])
C0456683 (UMLS CUI [5,2])
C0003211 (UMLS CUI [6,1])
C0683607 (UMLS CUI [6,2])
C0012544 (UMLS CUI [7,1])
C0683607 (UMLS CUI [7,2])
Premedication Condition Requirement Antibiotic therapy | Evaluation Special
Item
premedication- conditions that require antibiotic therapy will be evaluated on a case-by-case basis. (patients taking prophylaxis for joint replacements will not be excluded.)
boolean
C0033045 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0338237 (UMLS CUI [1,4])
C1261322 (UMLS CUI [2,1])
C0205555 (UMLS CUI [2,2])
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