ID

43774

Descripción

Development of Vitamin D as a Therapy for Breast Cancer - Phase II; ODM derived from: https://clinicaltrials.gov/show/NCT00656019

Link

https://clinicaltrials.gov/show/NCT00656019

Palabras clave

Versiones (2)
  1. 10/9/17 10/9/17 -
  2. 9/20/21 9/20/21 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

September 20, 2021

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00656019

Inglés

Eligibility Breast Cancer NCT00656019

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
women undergoing core needle biopsy for a breast abnormality suspicious for breast cancer. women who have undergone a core needle biopsy demonstrating breast cancer who have not yet had any further therapy are also eligible so long as their core needle biopsy is available for analysis.
Descripción

Gender | Core needle biopsy | Abnormality of the breast Suspicious Breast Carcinoma | Breast Carcinoma Core needle biopsy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C1318309
UMLS CUI [3,1]
C4025829
UMLS CUI [3,2]
C0750493
UMLS CUI [3,3]
C0678222
UMLS CUI [4,1]
C0678222
UMLS CUI [4,2]
C1318309
no prior therapy for breast cancer.
Descripción

Prior Therapy Absent Breast Carcinoma

Tipo de datos

boolean

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

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
ability to understand and the willingness to sign a written informed consent document.
Descripción

Comprehension Informed Consent | Informed Consent Willing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0600109
signed informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of parathyroid disease, hypercalcemia, or kidney stones.
Descripción

Parathyroid Diseases | Hypercalcemia | Kidney Calculi

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030517
UMLS CUI [2]
C0020437
UMLS CUI [3]
C0022650
supplemental vitamin d other than from a standard multiple vitamin or from standard formulations of calcium and vitamin d (e.g. calcium citrate with vitamin d) within the prior 6 months.
Descripción

Vitamin D supplement | Exception Standard Multivitamin preparation | Exception Standard Calcium + vitamin D | Exception Calcium Citrate / Vitamin D

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3541352
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1442989
UMLS CUI [2,3]
C0301532
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1442989
UMLS CUI [3,3]
C0719107
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0719098
history of renal failure requiring dialysis or kidney transplantation.
Descripción

Kidney Failure Requirement Dialysis | Kidney Failure Requirement Kidney Transplantation

Tipo de datos

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
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.)
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
supplemental calcium greater than 600 mg calcium per day during study.
Descripción

Calcium supplement U/day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3540037
UMLS CUI [1,2]
C0456683
patients for who initial treatment of their breast cancer will not be with breast conserving surgery or mastectomy.
Descripción

First line treatment Breast Carcinoma | Breast-Conserving Surgery Absent | Mastectomy Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0917927
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0024881
UMLS CUI [3,2]
C0332197
patients with locally advanced breast cancer
Descripción

Locally advanced breast cancer

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3495949
patients planned for neoadjuvant chemotherapy, hormonal therapy, or other systemic therapy.
Descripción

Chemotherapy Neoadjuvant Planned | Hormone Therapy Planned | Systemic therapy Planned

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0600558
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C1515119
UMLS CUI [3,2]
C1301732
patients planned for preoperative radiation therapy.
Descripción

Therapeutic radiology procedure Preoperative Planned

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0445204
UMLS CUI [1,3]
C1301732
patients with planned surgical therapy of their breast cancer that would not allow for at least 10 days of vitamin d intervention.
Descripción

Operative Surgical Procedure Planned Breast Carcinoma | Vitamin D Intervention Illicit

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C0042866
UMLS CUI [2,2]
C0184661
UMLS CUI [2,3]
C0332266
any condition potentially interfering with subjects ability to comply with taking study medication.
Descripción

Condition Interferes with Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0013230
any medical condition that would potentially interfere with vitamin d absorption, such as celiac sprue, ulcerative colitis.
Descripción

Medical condition Interferes with Vitamin D Absorption | Celiac Disease | Ulcerative Colitis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0042866
UMLS CUI [1,4]
C0237442
UMLS CUI [2]
C0007570
UMLS CUI [3]
C0009324
current participation in another research study that would increase risk to subject, in the opinion of the investigators
Descripción

Risk Increased by Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0205217
UMLS CUI [1,3]
C2348568
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Similar models

Eligibility Breast Cancer NCT00656019

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Core needle biopsy | Abnormality of the breast Suspicious Breast Carcinoma | Breast Carcinoma Core needle biopsy
Item
women undergoing core needle biopsy for a breast abnormality suspicious for breast cancer. women who have undergone a core needle biopsy demonstrating breast cancer who have not yet had any further therapy are also eligible so long as their core needle biopsy is available for analysis.
boolean
C0079399 (UMLS CUI [1])
C1318309 (UMLS CUI [2])
C4025829 (UMLS CUI [3,1])
C0750493 (UMLS CUI [3,2])
C0678222 (UMLS CUI [3,3])
C0678222 (UMLS CUI [4,1])
C1318309 (UMLS CUI [4,2])
Prior Therapy Absent Breast Carcinoma
Item
no prior therapy for breast cancer.
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Age
Item
age 18 years or older.
boolean
C0001779 (UMLS CUI [1])
Comprehension Informed Consent | Informed Consent Willing
Item
ability to understand and the willingness to sign a written informed consent document.
boolean
C0162340 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Parathyroid Diseases | Hypercalcemia | Kidney Calculi
Item
history of parathyroid disease, hypercalcemia, or kidney stones.
boolean
C0030517 (UMLS CUI [1])
C0020437 (UMLS CUI [2])
C0022650 (UMLS CUI [3])
Vitamin D supplement | Exception Standard Multivitamin preparation | Exception Standard Calcium + vitamin D | Exception Calcium Citrate / Vitamin D
Item
supplemental vitamin d other than from a standard multiple vitamin or from standard formulations of calcium and vitamin d (e.g. calcium citrate with vitamin d) within the prior 6 months.
boolean
C3541352 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1442989 (UMLS CUI [2,2])
C0301532 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1442989 (UMLS CUI [3,2])
C0719107 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0719098 (UMLS CUI [4,2])
Kidney Failure Requirement Dialysis | Kidney Failure Requirement Kidney Transplantation
Item
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
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])
Calcium supplement U/day
Item
supplemental calcium greater than 600 mg calcium per day during study.
boolean
C3540037 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
First line treatment Breast Carcinoma | Breast-Conserving Surgery Absent | Mastectomy Absent
Item
patients for who initial treatment of their breast cancer will not be with breast conserving surgery or mastectomy.
boolean
C1708063 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0917927 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0024881 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Locally advanced breast cancer
Item
patients with locally advanced breast cancer
boolean
C3495949 (UMLS CUI [1])
Chemotherapy Neoadjuvant Planned | Hormone Therapy Planned | Systemic therapy Planned
Item
patients planned for neoadjuvant chemotherapy, hormonal therapy, or other systemic therapy.
boolean
C0392920 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0279025 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C1515119 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Therapeutic radiology procedure Preoperative Planned
Item
patients planned for preoperative radiation therapy.
boolean
C1522449 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Operative Surgical Procedure Planned Breast Carcinoma | Vitamin D Intervention Illicit
Item
patients with planned surgical therapy of their breast cancer that would not allow for at least 10 days of vitamin d intervention.
boolean
C0543467 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0042866 (UMLS CUI [2,1])
C0184661 (UMLS CUI [2,2])
C0332266 (UMLS CUI [2,3])
Condition Interferes with Investigational New Drugs
Item
any condition potentially interfering with subjects ability to comply with taking study medication.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Medical condition Interferes with Vitamin D Absorption | Celiac Disease | Ulcerative Colitis
Item
any medical condition that would potentially interfere with vitamin d absorption, such as celiac sprue, ulcerative colitis.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0042866 (UMLS CUI [1,3])
C0237442 (UMLS CUI [1,4])
C0007570 (UMLS CUI [2])
C0009324 (UMLS CUI [3])
Risk Increased by Study Subject Participation Status
Item
current participation in another research study that would increase risk to subject, in the opinion of the investigators
boolean
C0035647 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
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