ID

44126

Description

Vitamin D and Breast Cancer: Does Weight Make a Difference?; ODM derived from: https://clinicaltrials.gov/show/NCT01472445

Link

https://clinicaltrials.gov/show/NCT01472445

Keywords

Versions (2)
  1. 9/8/19 9/8/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01472445

English

Eligibility Breast Cancer NCT01472445

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
3.1.1 women who have undergone a core needle biopsy demonstrating an operable breast cancer whom have not yet had any further therapy.
Description

Gender | Breast Carcinoma Operable Core needle biopsy | Therapeutic procedure further Absent

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0205188
UMLS CUI [2,3]
C1318309
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1524062
UMLS CUI [3,3]
C0332197
3.1.2 no prior therapy for breast cancer.
Description

Prior Therapy Absent Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0678222
3.1.4 age 18 years or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3.1.5 any menopausal status
Description

Menopausal Status Any

Data type

boolean

Alias
UMLS CUI [1,1]
C3829127
UMLS CUI [1,2]
C1552551
3.1.6 planned surgical resection of breast cancer or repeat core biopsy tissue sampling prior to initiation of neoadjuvant systemic chemotherapy.
Description

Excision Breast Carcinoma Planned | Core biopsy Repeated Tissue sampling | Status pre- Neoadjuvant Systemic Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C1318309
UMLS CUI [2,2]
C0205341
UMLS CUI [2,3]
C4266460
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C0600558
UMLS CUI [3,3]
C1883256
3.1.7 availability of tissue blocks from initial core needle biopsy.
Description

Availability of Tissue Block | Tissue Core needle biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0040300
UMLS CUI [1,3]
C1533157
UMLS CUI [2,1]
C0040300
UMLS CUI [2,2]
C1318309
3.1.8 signed informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
3.1.9 willing to discontinue use of all supplements containing vitamin d for the duration of the study, and take only the vitamin d provided by the study.
Description

Discontinuation Vitamin D supplement | Intake Vitamin D Consistent with Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1444662
UMLS CUI [1,2]
C3541352
UMLS CUI [2,1]
C1512806
UMLS CUI [2,2]
C0042866
UMLS CUI [2,3]
C0332290
UMLS CUI [2,4]
C2348563
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
3.2.1 presence of any metastatic lesion.
Description

Metastatic Lesion

Data type

boolean

Alias
UMLS CUI [1]
C1513183
3.2.2 history of parathyroid disease, hypercalcemia, or kidney stones.
Description

Parathyroid Disease | Hypercalcemia | Kidney Calculi

Data type

boolean

Alias
UMLS CUI [1]
C0030517
UMLS CUI [2]
C0020437
UMLS CUI [3]
C0022650
3.2.3 history of serm or aromatase inhibitor therapy.
Description

Selective Estrogen Receptor Modulators | Aromatase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0732611
UMLS CUI [2]
C0593802
3.2.4 taking metformin.
Description

Metformin

Data type

boolean

Alias
UMLS CUI [1]
C0025598
3.2.5 history of renal failure requiring dialysis or kidney transplantation.
Description

Kidney Failure Requirement Dialysis | Kidney Failure Requirement Kidney Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0011946
UMLS CUI [2,1]
C0035078
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0022671
3.2.6 women who are known to be pregnant or who are nursing. (as vitamin d does not have toxicity to the fetus, a negative pregnancy test is not a requirement to participate in the study.)
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3.2.7 patients planned for surgical therapy of their breast cancer or initiation of systemic chemotherapy, that would not allow for at least 7 days of vitamin d intervention
Description

Operative Surgical Procedure Planned Breast Carcinoma | Initiation Systemic Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C1704686
UMLS CUI [2,2]
C1883256
3.2.9 any condition potentially interfering with subjects ability to comply with taking study medication.
Description

Condition Interferes with Compliance Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1321605
UMLS CUI [1,4]
C0013230
3.2.10 any medical condition that would potentially interfere with vitamin d absorption.
Description

Medical condition Interferes with Vitamin D Absorption

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0042866
UMLS CUI [1,4]
C0237442
3.2.11 current participation in another research study that would increase risk to subject, in the opinion of the investigators.
Description

Study Subject Participation Status | Research study | Study Subject Participation Status At risk Patient

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0681814
UMLS CUI [3,1]
C2348568
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0030705
3.2.12 patients currently taking more than 2000 iu of vitamin d.
Description

Intake Vitamin D Amount

Data type

boolean

Alias
UMLS CUI [1,1]
C1512806
UMLS CUI [1,2]
C0042866
UMLS CUI [1,3]
C1265611
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Similar models

Eligibility Breast Cancer NCT01472445

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Breast Carcinoma Operable Core needle biopsy | Therapeutic procedure further Absent
Item
3.1.1 women who have undergone a core needle biopsy demonstrating an operable breast cancer whom have not yet had any further therapy.
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0205188 (UMLS CUI [2,2])
C1318309 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C1524062 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Prior Therapy Absent Breast Carcinoma
Item
3.1.2 no prior therapy for breast cancer.
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Age
Item
3.1.4 age 18 years or older.
boolean
C0001779 (UMLS CUI [1])
Menopausal Status Any
Item
3.1.5 any menopausal status
boolean
C3829127 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
Excision Breast Carcinoma Planned | Core biopsy Repeated Tissue sampling | Status pre- Neoadjuvant Systemic Chemotherapy
Item
3.1.6 planned surgical resection of breast cancer or repeat core biopsy tissue sampling prior to initiation of neoadjuvant systemic chemotherapy.
boolean
C0728940 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C1318309 (UMLS CUI [2,1])
C0205341 (UMLS CUI [2,2])
C4266460 (UMLS CUI [2,3])
C0332152 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C1883256 (UMLS CUI [3,3])
Availability of Tissue Block | Tissue Core needle biopsy
Item
3.1.7 availability of tissue blocks from initial core needle biopsy.
boolean
C0470187 (UMLS CUI [1,1])
C0040300 (UMLS CUI [1,2])
C1533157 (UMLS CUI [1,3])
C0040300 (UMLS CUI [2,1])
C1318309 (UMLS CUI [2,2])
Informed Consent
Item
3.1.8 signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Discontinuation Vitamin D supplement | Intake Vitamin D Consistent with Study Protocol
Item
3.1.9 willing to discontinue use of all supplements containing vitamin d for the duration of the study, and take only the vitamin d provided by the study.
boolean
C1444662 (UMLS CUI [1,1])
C3541352 (UMLS CUI [1,2])
C1512806 (UMLS CUI [2,1])
C0042866 (UMLS CUI [2,2])
C0332290 (UMLS CUI [2,3])
C2348563 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Metastatic Lesion
Item
3.2.1 presence of any metastatic lesion.
boolean
C1513183 (UMLS CUI [1])
Parathyroid Disease | Hypercalcemia | Kidney Calculi
Item
3.2.2 history of parathyroid disease, hypercalcemia, or kidney stones.
boolean
C0030517 (UMLS CUI [1])
C0020437 (UMLS CUI [2])
C0022650 (UMLS CUI [3])
Selective Estrogen Receptor Modulators | Aromatase Inhibitors
Item
3.2.3 history of serm or aromatase inhibitor therapy.
boolean
C0732611 (UMLS CUI [1])
C0593802 (UMLS CUI [2])
Metformin
Item
3.2.4 taking metformin.
boolean
C0025598 (UMLS CUI [1])
Kidney Failure Requirement Dialysis | Kidney Failure Requirement Kidney Transplantation
Item
3.2.5 history of renal failure requiring dialysis or kidney transplantation.
boolean
C0035078 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0011946 (UMLS CUI [1,3])
C0035078 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0022671 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
3.2.6 women who are known to be pregnant or who are nursing. (as vitamin d does not have toxicity to the fetus, a negative pregnancy test is not a requirement to participate in the study.)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Operative Surgical Procedure Planned Breast Carcinoma | Initiation Systemic Chemotherapy
Item
3.2.7 patients planned for surgical therapy of their breast cancer or initiation of systemic chemotherapy, that would not allow for at least 7 days of vitamin d intervention
boolean
C0543467 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C1704686 (UMLS CUI [2,1])
C1883256 (UMLS CUI [2,2])
Condition Interferes with Compliance Investigational New Drugs
Item
3.2.9 any condition potentially interfering with subjects ability to comply with taking study medication.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
Medical condition Interferes with Vitamin D Absorption
Item
3.2.10 any medical condition that would potentially interfere with vitamin d absorption.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0042866 (UMLS CUI [1,3])
C0237442 (UMLS CUI [1,4])
Study Subject Participation Status | Research study | Study Subject Participation Status At risk Patient
Item
3.2.11 current participation in another research study that would increase risk to subject, in the opinion of the investigators.
boolean
C2348568 (UMLS CUI [1])
C0681814 (UMLS CUI [2])
C2348568 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0030705 (UMLS CUI [3,3])
Intake Vitamin D Amount
Item
3.2.12 patients currently taking more than 2000 iu of vitamin d.
boolean
C1512806 (UMLS CUI [1,1])
C0042866 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
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