ID

38021

Beschrijving

Study of Vitamin D Supplementation Tailored to Vitamin D Deficiency in Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01480869

Link

https://clinicaltrials.gov/show/NCT01480869

Trefwoorden

Versies (1)
  1. 09-09-19 09-09-19 -
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See clinicaltrials.gov

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9 september 2019

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01480869

Engels

Eligibility Breast Cancer NCT01480869

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
breast adenocarcinoma treated by neoadjuvant or adjuvant chemotherapy within 12 months prior to study enrollment
Beschrijving

Neoadjuvant Chemotherapy Breast adenocarcinoma | Adjuvant Chemotherapy Breast adenocarcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
UMLS CUI [1,3]
C0858252
UMLS CUI [2,1]
C0085533
UMLS CUI [2,2]
C0858252
who performance status 0-1
Beschrijving

WHO performance status scale

Datatype

boolean

Alias
UMLS CUI [1]
C1298650
age ≥18 years old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
affiliation to a social security regime or beneficiary of equivalent social protection
Beschrijving

Affiliation Social Security Program | Beneficiary Social Protection Equivalent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1510825
UMLS CUI [1,2]
C0037435
UMLS CUI [2,1]
C1550502
UMLS CUI [2,2]
C0242457
UMLS CUI [2,3]
C0205163
written informed consent provided before any study specific procedures
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
complementary inclusion criterion for randomization
Beschrijving

Randomization

Datatype

boolean

Alias
UMLS CUI [1]
C0034656
proved vitamin d deficiency as defined by serum vitamin d level lower than 30 ng/ml (75 nmol/l).
Beschrijving

Vitamin D Deficiency | Serum vitamin D measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0042870
UMLS CUI [2]
C0428586
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
metastatic disease
Beschrijving

Neoplasm Metastasis

Datatype

boolean

Alias
UMLS CUI [1]
C0027627
history or presence of any other malignancy (except curatively treated nonmelanoma skin cancer or in situ cervix carcinoma) ………….
Beschrijving

Cancer Other | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0851140
traités dans les 5 ans précédents.
Beschrijving

Patient Treated

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1522326
contraindication to calcium or cholecalciferol
Beschrijving

Medical contraindication Calcium | Medical contraindication Cholecalciferol

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0006675
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0008318
known severe hypersensitivity to vitamin d or to calcium supplementation or to one of the excipients.
Beschrijving

Severe allergy Vitamin D | Severe allergy Calcium supplementation | Severe allergy Vitamin D Excipient | Severe allergy Calcium supplementation Excipient

Datatype

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0042866
UMLS CUI [2,1]
C2945656
UMLS CUI [2,2]
C1096745
UMLS CUI [3,1]
C2945656
UMLS CUI [3,2]
C0042866
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C2945656
UMLS CUI [4,2]
C1096745
UMLS CUI [4,3]
C0015237
disease and/or medical conditions accompanied by hypercalcaemia and/or hypercalciuria
Beschrijving

Disease Associated with Hypercalcemia | Medical condition Associated with Hypercalcemia | Disease Associated with Hypercalciuria | Medical condition Associated with Hypercalciuria

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0020437
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0020437
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0020438
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0332281
UMLS CUI [4,3]
C0020438
calcium lithiasis and tissue calcification
Beschrijving

Calcium Lithiasis | Calcinosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006675
UMLS CUI [1,2]
C0023869
UMLS CUI [2]
C0006663
hypervitaminosis d
Beschrijving

Hypervitaminosis D

Datatype

boolean

Alias
UMLS CUI [1]
C1442839
presence of significant comorbidities:
Beschrijving

Comorbidity Significant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0750502
i) uncontrolled endocrine disease ii) known disorders of calcium phophorus laboratory testing iii) proved osteopenia or osteoporosis requiring vitamin d and calcium supplements
Beschrijving

Endocrine System Disease Uncontrolled | Phosphorus and calcium disorders Laboratory testing | Osteopenia Requirement Vitamin D supplement | Osteoporosis Requirement Vitamin D supplement | Osteopenia Requirement Calcium supplements | Osteoporosis Requirement Calcium supplements

Datatype

boolean

Alias
UMLS CUI [1,1]
C0014130
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0564731
UMLS CUI [2,2]
C0022885
UMLS CUI [3,1]
C0029453
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C3541352
UMLS CUI [4,1]
C0029456
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C3541352
UMLS CUI [5,1]
C0029453
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C3540037
UMLS CUI [6,1]
C0029456
UMLS CUI [6,2]
C1514873
UMLS CUI [6,3]
C3540037
concomitant treatment with other experimental products or another vitamin d calcium treatment
Beschrijving

Investigational New Drugs | Calcium + vitamin D

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0719107
pregnancy, breastfeeding or of reproductive potential not using an effective contraceptive method
Beschrijving

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
legal inability or restricted legal ability. medical or psychological conditions not allowing proper study completion or informed consent signature
Beschrijving

Legal capacity Lacking | Legal capacity Restricted | Medical condition Preventing Completion of clinical trial | Mental condition Preventing Completion of clinical trial | Medical condition Preventing Informed Consent | Mental condition Preventing Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0683673
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C0683673
UMLS CUI [2,2]
C0443288
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C2732579
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C2732579
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C1292733
UMLS CUI [5,3]
C0021430
UMLS CUI [6,1]
C3840291
UMLS CUI [6,2]
C1292733
UMLS CUI [6,3]
C0021430
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Similar models

Eligibility Breast Cancer NCT01480869

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Neoadjuvant Chemotherapy Breast adenocarcinoma | Adjuvant Chemotherapy Breast adenocarcinoma
Item
breast adenocarcinoma treated by neoadjuvant or adjuvant chemotherapy within 12 months prior to study enrollment
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C0858252 (UMLS CUI [1,3])
C0085533 (UMLS CUI [2,1])
C0858252 (UMLS CUI [2,2])
WHO performance status scale
Item
who performance status 0-1
boolean
C1298650 (UMLS CUI [1])
Age
Item
age ≥18 years old
boolean
C0001779 (UMLS CUI [1])
Affiliation Social Security Program | Beneficiary Social Protection Equivalent
Item
affiliation to a social security regime or beneficiary of equivalent social protection
boolean
C1510825 (UMLS CUI [1,1])
C0037435 (UMLS CUI [1,2])
C1550502 (UMLS CUI [2,1])
C0242457 (UMLS CUI [2,2])
C0205163 (UMLS CUI [2,3])
Informed Consent
Item
written informed consent provided before any study specific procedures
boolean
C0021430 (UMLS CUI [1])
Randomization
Item
complementary inclusion criterion for randomization
boolean
C0034656 (UMLS CUI [1])
Vitamin D Deficiency | Serum vitamin D measurement
Item
proved vitamin d deficiency as defined by serum vitamin d level lower than 30 ng/ml (75 nmol/l).
boolean
C0042870 (UMLS CUI [1])
C0428586 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis
Item
metastatic disease
boolean
C0027627 (UMLS CUI [1])
Cancer Other | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix
Item
history or presence of any other malignancy (except curatively treated nonmelanoma skin cancer or in situ cervix carcinoma) ………….
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0699893 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
Patient Treated
Item
traités dans les 5 ans précédents.
boolean
C0030705 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
Medical contraindication Calcium | Medical contraindication Cholecalciferol
Item
contraindication to calcium or cholecalciferol
boolean
C1301624 (UMLS CUI [1,1])
C0006675 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0008318 (UMLS CUI [2,2])
Severe allergy Vitamin D | Severe allergy Calcium supplementation | Severe allergy Vitamin D Excipient | Severe allergy Calcium supplementation Excipient
Item
known severe hypersensitivity to vitamin d or to calcium supplementation or to one of the excipients.
boolean
C2945656 (UMLS CUI [1,1])
C0042866 (UMLS CUI [1,2])
C2945656 (UMLS CUI [2,1])
C1096745 (UMLS CUI [2,2])
C2945656 (UMLS CUI [3,1])
C0042866 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C2945656 (UMLS CUI [4,1])
C1096745 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Disease Associated with Hypercalcemia | Medical condition Associated with Hypercalcemia | Disease Associated with Hypercalciuria | Medical condition Associated with Hypercalciuria
Item
disease and/or medical conditions accompanied by hypercalcaemia and/or hypercalciuria
boolean
C0012634 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0020437 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0020437 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0020438 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C0020438 (UMLS CUI [4,3])
Calcium Lithiasis | Calcinosis
Item
calcium lithiasis and tissue calcification
boolean
C0006675 (UMLS CUI [1,1])
C0023869 (UMLS CUI [1,2])
C0006663 (UMLS CUI [2])
Hypervitaminosis D
Item
hypervitaminosis d
boolean
C1442839 (UMLS CUI [1])
Comorbidity Significant
Item
presence of significant comorbidities:
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Endocrine System Disease Uncontrolled | Phosphorus and calcium disorders Laboratory testing | Osteopenia Requirement Vitamin D supplement | Osteoporosis Requirement Vitamin D supplement | Osteopenia Requirement Calcium supplements | Osteoporosis Requirement Calcium supplements
Item
i) uncontrolled endocrine disease ii) known disorders of calcium phophorus laboratory testing iii) proved osteopenia or osteoporosis requiring vitamin d and calcium supplements
boolean
C0014130 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0564731 (UMLS CUI [2,1])
C0022885 (UMLS CUI [2,2])
C0029453 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C3541352 (UMLS CUI [3,3])
C0029456 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C3541352 (UMLS CUI [4,3])
C0029453 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C3540037 (UMLS CUI [5,3])
C0029456 (UMLS CUI [6,1])
C1514873 (UMLS CUI [6,2])
C3540037 (UMLS CUI [6,3])
Investigational New Drugs | Calcium + vitamin D
Item
concomitant treatment with other experimental products or another vitamin d calcium treatment
boolean
C0013230 (UMLS CUI [1])
C0719107 (UMLS CUI [2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
pregnancy, breastfeeding or of reproductive potential not using an effective contraceptive method
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Legal capacity Lacking | Legal capacity Restricted | Medical condition Preventing Completion of clinical trial | Mental condition Preventing Completion of clinical trial | Medical condition Preventing Informed Consent | Mental condition Preventing Informed Consent
Item
legal inability or restricted legal ability. medical or psychological conditions not allowing proper study completion or informed consent signature
boolean
C0683673 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0683673 (UMLS CUI [2,1])
C0443288 (UMLS CUI [2,2])
C3843040 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C2732579 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C1292733 (UMLS CUI [5,2])
C0021430 (UMLS CUI [5,3])
C3840291 (UMLS CUI [6,1])
C1292733 (UMLS CUI [6,2])
C0021430 (UMLS CUI [6,3])
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