Informações:
Falhas:
ID
44483
Descrição
Caloric Restriction in Treating Patients With Stage 0-I Breast Cancer Undergoing Surgery and Radiation Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01819233
Link
https://clinicaltrials.gov/show/NCT01819233
Palavras-chave
Versões (2)
- 20/01/2018 20/01/2018 -
- 27/09/2021 27/09/2021 -
Titular dos direitos
https://clinicaltrials.gov/show/NCT01819233
Transferido a
27 de setembro de 2021
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Ductal Breast Carcinoma in Situ NCT01819233
Eligibility Ductal Breast Carcinoma in Situ NCT01819233
- StudyEvent: Eligibility
Similar models
Eligibility Ductal Breast Carcinoma in Situ NCT01819233
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
breast cancer or ductal carcinoma in situ
Item
1. pathologically proven diagnosis of ductal carcinoma in situ (dcis) or invasive breast cancer
boolean
C0007124 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
C0678222 (UMLS CUI [2])
breast cancer conservation therapy
Item
2. ability to have breast conservation as determined by the judgment of the radiation oncologist, for which the radiation oncologist has determined that he or she will only treat the whole breast and not regional lymph nodes
boolean
C0678222 (UMLS CUI [1])
C0917927 (UMLS CUI [2])
C0917927 (UMLS CUI [2])
gender
Item
3. the patient must be female
boolean
C0079399 (UMLS CUI [1])
age
Item
4. age >= 18
boolean
C0001779 (UMLS CUI [1])
multifocal breast cancer
Item
5. if multifocal breast cancer, then it must be able to be resected through a single lumpectomy incision
boolean
C0678222 (UMLS CUI [1,1])
C0205292 (UMLS CUI [1,2])
C0024885 (UMLS CUI [2])
C0205292 (UMLS CUI [1,2])
C0024885 (UMLS CUI [2])
breast cancer stage and metastases
Item
6. appropriate stage for protocol entry, including no clinical evidence for distant metastases, based upon the following minimum diagnostic workup:
boolean
C0678222 (UMLS CUI [1,1])
C1300072 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
C1300072 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
physical examination with breast exam, weight and karnofsky performance status
Item
1. history/physical examination, including breast exam and documentation of weight and karnofsky performance status of 80-100 for at least 60 days prior to study entry
boolean
C0031809 (UMLS CUI [1,1])
C2347781 (UMLS CUI [1,2])
C0005910 (UMLS CUI [1,3])
C0206065 (UMLS CUI [2])
C2347781 (UMLS CUI [1,2])
C0005910 (UMLS CUI [1,3])
C0206065 (UMLS CUI [2])
mammography
Item
2. ipsilateral mammogram within 6 months prior to study entry
boolean
C0024671 (UMLS CUI [1])
pregnancy
Item
7. women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry
boolean
C0032961 (UMLS CUI [1,1])
C0205160 (UMLS CUI [1,2])
C0205160 (UMLS CUI [1,2])
pregnancy, breastfeeding and contraception
Item
8. women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
informed consent
Item
9. patient must capable of and provide study specific informed consent prior to study entry
boolean
C0021430 (UMLS CUI [1])
body mass index
Item
10. body mass index (bmi) >= 21
boolean
C1305855 (UMLS CUI [1])
weight
Item
11. weight >= 100 lbs
boolean
C0005910 (UMLS CUI [1])
cancer history
Item
12. no prior history of non-breast malignancies in the past 2 years unless it was a non-melanomatous skin lesion or carcinoma in situ of the cervix
boolean
C0262926 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,2])
comorbidities
Item
13. patient must not have any of the following severe, active co-morbidity, defined as follows:
boolean
C0009488 (UMLS CUI [1])
unstable angina and/or congestive heart failure
Item
1. unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
boolean
C0018802 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0002965 (UMLS CUI [2])
myocardial infarction
Item
2. transmural myocardial infarction within the last 6 months
boolean
C0027051 (UMLS CUI [1])
current infection therapy, antibiotics
Item
3. acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
boolean
C0009450 (UMLS CUI [1])
C0003232 (UMLS CUI [2])
C0003232 (UMLS CUI [2])
respiratory illness
Item
4. chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
boolean
C0035204 (UMLS CUI [1])
C0024117 (UMLS CUI [2])
C0024117 (UMLS CUI [2])
hepatic insufficiency
Item
5. hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
boolean
C1306571 (UMLS CUI [1])
HIV or AIDS
Item
6. acquired immune deficiency syndrome (aids) or human immunodeficiency virus (hiv) positive based upon current centers for disease and control (cdc) definition; note, however, that hiv testing is not required for entry into this protocol; the need to exclude patients with aids or hiv from this protocol is necessary because anti-retrovirals may alter patient metabolism
boolean
C0019699 (UMLS CUI [1,1])
C0001175 (UMLS CUI [1,2])
C0001175 (UMLS CUI [1,2])
skin diseases
Item
14. patient must not have active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
boolean
C1123023 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
prior breast cancer therapy
Item
15. no prior radiotherapy to the ipsilateral breast or prior radiation to the region of the breast that would result in overlap of radiation therapy fields
boolean
C0678222 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
gastrointestinal disorder
Item
16. patient may not have any active gastrointestinal/malabsorption disorder at the discretion of the principal investigator
boolean
C0017178 (UMLS CUI [1])
inflammatory bowel disease
Item
1. inflammatory bowel disease
boolean
C0021390 (UMLS CUI [1])
celiac disease
Item
2. celiac disease
boolean
C0007570 (UMLS CUI [1])
chronic pancreatitis
Item
3. chronic pancreatitis
boolean
C0030305 (UMLS CUI [1])
chronic diarrhea or vomiting
Item
4. chronic diarrhea or vomiting
boolean
C0042963 (UMLS CUI [1])
C0011991 (UMLS CUI [2])
C0011991 (UMLS CUI [2])
eating disorder
Item
5. active eating disorder
boolean
C0013473 (UMLS CUI [1])
creatinine
Item
17. creatinine < 1.7
boolean
C0201976 (UMLS CUI [1])
steriods
Item
18. not currently taking steroids
boolean
C0038317 (UMLS CUI [1])
pituitary tumor
Item
19. no currently active pituitary secreting tumors up to physician discretion
boolean
C0032005 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,2])
drug/alcohol dependence
Item
20. no history of or current active drug/alcohol dependence
boolean
C0038580 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
C0085762 (UMLS CUI [2])
informed consent not possible
Item
21. no patients being decisionally impaired
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,2])
breast conservation not possible
Item
1. patient is not a candidate for breast conservation
boolean
C0917927 (UMLS CUI [1,1])
C1518422 (UMLS CUI [1,2])
C0332149 (UMLS CUI [1,3])
C1518422 (UMLS CUI [1,2])
C0332149 (UMLS CUI [1,3])
gender
Item
2. patient is male
boolean
C0079399 (UMLS CUI [1])
age
Item
3. age < 18 years
boolean
C0001779 (UMLS CUI [1])
lymph node metastases
Item
4. patient requires regional lymph node irradiation therapy
boolean
C0024204 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,2])
metastases
Item
5. patient has evidence of distant metastases
boolean
C0027627 (UMLS CUI [1])
karnofsky performance status
Item
6. karnofsky performance status less than 80% within 60 days prior to study
boolean
C0206065 (UMLS CUI [1])
mammography
Item
7. ipsilateral mammogram done greater than 6 months prior to study
boolean
C0024671 (UMLS CUI [1])
pregnancy, hcg positive
Item
8. women of childbearing potential with a positive serum beta human chorionic gonadotropin (hcg)
boolean
C0032961 (UMLS CUI [1])
compliance and mental disorders
Item
9. patient has a history of dementia, psychosis or other disorder affecting their mental status to the point where they cannot consent or comply with study guidelines
boolean
C0004936 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,2])
BMI
Item
10. bmi < 21
boolean
C1305855 (UMLS CUI [1])
weight
Item
11. weight < 100 lbs
boolean
C0005910 (UMLS CUI [1])
weight loss
Item
12. weight loss >= 10% in the last 3 months (mos)
boolean
C1262477 (UMLS CUI [1])
cancer history
Item
13. prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 2 years prior to registration
boolean
C0262926 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,2])
multifocal breast cancer
Item
14. two or more breast cancers not resectable through a single lumpectomy incision
boolean
C0678222 (UMLS CUI [1,1])
C0205292 (UMLS CUI [1,2])
C0024885 (UMLS CUI [2])
C0205292 (UMLS CUI [1,2])
C0024885 (UMLS CUI [2])
sarcoma or lymphoma
Item
15. non-epithelial breast malignancies such as sarcoma or lymphoma
boolean
C1261473 (UMLS CUI [1])
C0024299 (UMLS CUI [2])
C0024299 (UMLS CUI [2])
prior breast cancer therapy
Item
16. prior radiotherapy to the ipsilateral breast or prior radiation to the region of the breast that would result in overlap of radiation therapy fields
boolean
C0678222 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
comorbidities
Item
17. severe, active co-morbidity, defined as follows:
boolean
C0009488 (UMLS CUI [1])
unstable angina and/or congestive heart failure
Item
1. unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
boolean
C0018802 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0002965 (UMLS CUI [2])
myocardial infarction
Item
2. transmural myocardial infarction within the last 6 months
boolean
C0027051 (UMLS CUI [1])
current infection therapy, antibiotics
Item
3. acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
boolean
C0009450 (UMLS CUI [1])
C0003232 (UMLS CUI [2])
C0003232 (UMLS CUI [2])
respiratory illness
Item
4. chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
boolean
C0035204 (UMLS CUI [1])
C0024117 (UMLS CUI [2])
C0024117 (UMLS CUI [2])
hepatic insufficiency
Item
5. hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
boolean
C1306571 (UMLS CUI [1])
HIV or AIDS
Item
6. acquired immune deficiency syndrome (aids) or hiv positive based upon current cdc definition; note, however, that hiv testing is not required for entry into this protocol; the need to exclude patients with aids or hiv from this protocol is necessary because anti-retrovirals may alter patient metabolism
boolean
C0019699 (UMLS CUI [1,1])
C0001175 (UMLS CUI [1,2])
C0001175 (UMLS CUI [1,2])
skin diseases
Item
18. active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
boolean
C1123023 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
gastrointestinal disorder
Item
19. active gastrointestinal/malabsorption disorder at the discretion of the principal investigator
boolean
C0017178 (UMLS CUI [1])
inflammatory bowel disease
Item
1. inflammatory bowel disease
boolean
C0021390 (UMLS CUI [1])
celiac disease
Item
2. celiac disease
boolean
C0007570 (UMLS CUI [1])
chronic pancreatitis
Item
3. chronic pancreatitis
boolean
C0030305 (UMLS CUI [1])
chronic diarrhea or vomiting
Item
4. chronic diarrhea or vomiting
boolean
C0042963 (UMLS CUI [1])
C0011991 (UMLS CUI [2])
C0011991 (UMLS CUI [2])
eating disorders
Item
5. active eating disorder
boolean
C0013473 (UMLS CUI [1])
creatinine
Item
20. creatinine >= 1.7
boolean
C0201976 (UMLS CUI [1])
use of steroids
Item
21. current use of steroids
boolean
C0038317 (UMLS CUI [1])
pituitary tumors
Item
22. pituitary secreting tumors up to physician discretion
boolean
C0032005 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,2])
drug/alcohol dependence
Item
23. active drug/alcohol dependence or abuse history
boolean
C0038580 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
C0085762 (UMLS CUI [2])
informed consent not possible
Item
24. decisionally impaired patients
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,2])