ID

26058

Beskrivning

Prophylactic Irradiation to the Contralateral Breast for BRCA Mutation Carriers Undergoing Treatment for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00496288

Länk

https://clinicaltrials.gov/show/NCT00496288

Nyckelord

Versioner (1)
  1. 2017-10-05 2017-10-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 oktober 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00496288

Engelsk

Eligibility Breast Cancer NCT00496288

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. female patient diagnosed with stage i-iii breast cancer (ajcc 6), undergoing breast irradiation as part of her adjuvant therapy.
Beskrivning

Gender | Breast Carcinoma TNM clinical staging | Irradiation of breast Adjuvant therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C3258246
UMLS CUI [3,1]
C2148528
UMLS CUI [3,2]
C0677850
2. the patient must be a carrier of a deleterious mutation in brca 1/2.
Beskrivning

BRCA1 Mutation Carrier Deleterious | BRCA2 Mutation Carrier Deleterious

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3899965
UMLS CUI [1,2]
C2985436
UMLS CUI [2,1]
C3899964
UMLS CUI [2,2]
C2985436
3. age above 30 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
4. the patient may receive any regimen of adjuvant chemotherapy, according to the treating physician. all cycles of chemotherapy must be completed at least 3 weeks prior to the start of radiation therapy.
Beskrivning

Chemotherapy, Adjuvant | Chemotherapy cycle All Completed | Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0085533
UMLS CUI [2,1]
C1302181
UMLS CUI [2,2]
C0444868
UMLS CUI [2,3]
C0205197
UMLS CUI [3]
C1522449
5. the patient may be treated with hormonal therapy before, during or after study entry, according to the guidelines of her treating center.
Beskrivning

Hormone Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0279025
6. the patient must have negative gadolinium based mri of the contralateral breast, no more than 6 months prior to study entry.
Beskrivning

MRI gadolinium-enhanced Negative Breast Contralateral

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0855566
UMLS CUI [1,2]
C1513916
UMLS CUI [1,3]
C0006141
UMLS CUI [1,4]
C0441988
7. the patient refused prophylactic contralateral mastectomy.
Beskrivning

Contralateral Prophylactic Mastectomy Refused

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1705768
UMLS CUI [1,2]
C1705116
8. the patient is aware that subsequent breast cancer in the irradiated breast will probably mandate mastectomy.
Beskrivning

irradiation of breast | Breast Carcinoma subsequent | Mastectomy Probably

Datatyp

boolean

Alias
UMLS CUI [1]
C2148528
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0332282
UMLS CUI [3,1]
C0024881
UMLS CUI [3,2]
C0750492
9. the patient consent for contralateral prophylactic irradiation. -
Beskrivning

Consent Therapeutic radiology procedure Contralateral Prophylactic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1511481
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0441988
UMLS CUI [1,4]
C0199176
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. metastatic breast cancer.
Beskrivning

Secondary malignant neoplasm of female breast

Datatyp

boolean

Alias
UMLS CUI [1]
C0346993
2. previous irradiation of the breast or chest wall.
Beskrivning

Irradiation of breast Previous | Irradiation of chest wall Previous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2148528
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C2064934
UMLS CUI [2,2]
C0205156
3. pregnancy.
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
4. no concurrent chemotherapy is allowed
Beskrivning

Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
5. patients with active connective tissue diseases are excluded due to the potential risk of significant radiotherapy toxicity.
Beskrivning

Connective Tissue Diseases | Risk Toxicity due to radiotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0009782
UMLS CUI [2,1]
C0035647
UMLS CUI [2,2]
C1302210
6. patients who are unable to lie on their back and raise their arms above their heads in the treatment planning position for radiotherapy are excluded -
Beskrivning

Lacking Able to lie down Supine Position | Patients Inappropriate Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0560841
UMLS CUI [1,3]
C0038846
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C1522449
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Similar models

Eligibility Breast Cancer NCT00496288

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Breast Carcinoma TNM clinical staging | Irradiation of breast Adjuvant therapy
Item
1. female patient diagnosed with stage i-iii breast cancer (ajcc 6), undergoing breast irradiation as part of her adjuvant therapy.
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C2148528 (UMLS CUI [3,1])
C0677850 (UMLS CUI [3,2])
BRCA1 Mutation Carrier Deleterious | BRCA2 Mutation Carrier Deleterious
Item
2. the patient must be a carrier of a deleterious mutation in brca 1/2.
boolean
C3899965 (UMLS CUI [1,1])
C2985436 (UMLS CUI [1,2])
C3899964 (UMLS CUI [2,1])
C2985436 (UMLS CUI [2,2])
Age
Item
3. age above 30 years.
boolean
C0001779 (UMLS CUI [1])
Chemotherapy, Adjuvant | Chemotherapy cycle All Completed | Therapeutic radiology procedure
Item
4. the patient may receive any regimen of adjuvant chemotherapy, according to the treating physician. all cycles of chemotherapy must be completed at least 3 weeks prior to the start of radiation therapy.
boolean
C0085533 (UMLS CUI [1])
C1302181 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3])
Hormone Therapy
Item
5. the patient may be treated with hormonal therapy before, during or after study entry, according to the guidelines of her treating center.
boolean
C0279025 (UMLS CUI [1])
MRI gadolinium-enhanced Negative Breast Contralateral
Item
6. the patient must have negative gadolinium based mri of the contralateral breast, no more than 6 months prior to study entry.
boolean
C0855566 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,3])
C0441988 (UMLS CUI [1,4])
Contralateral Prophylactic Mastectomy Refused
Item
7. the patient refused prophylactic contralateral mastectomy.
boolean
C1705768 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
irradiation of breast | Breast Carcinoma subsequent | Mastectomy Probably
Item
8. the patient is aware that subsequent breast cancer in the irradiated breast will probably mandate mastectomy.
boolean
C2148528 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
C0024881 (UMLS CUI [3,1])
C0750492 (UMLS CUI [3,2])
Consent Therapeutic radiology procedure Contralateral Prophylactic
Item
9. the patient consent for contralateral prophylactic irradiation. -
boolean
C1511481 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0441988 (UMLS CUI [1,3])
C0199176 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Secondary malignant neoplasm of female breast
Item
1. metastatic breast cancer.
boolean
C0346993 (UMLS CUI [1])
Irradiation of breast Previous | Irradiation of chest wall Previous
Item
2. previous irradiation of the breast or chest wall.
boolean
C2148528 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C2064934 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Pregnancy
Item
3. pregnancy.
boolean
C0032961 (UMLS CUI [1])
Chemotherapy
Item
4. no concurrent chemotherapy is allowed
boolean
C0392920 (UMLS CUI [1])
Connective Tissue Diseases | Risk Toxicity due to radiotherapy
Item
5. patients with active connective tissue diseases are excluded due to the potential risk of significant radiotherapy toxicity.
boolean
C0009782 (UMLS CUI [1])
C0035647 (UMLS CUI [2,1])
C1302210 (UMLS CUI [2,2])
Lacking Able to lie down Supine Position | Patients Inappropriate Therapeutic radiology procedure
Item
6. patients who are unable to lie on their back and raise their arms above their heads in the treatment planning position for radiotherapy are excluded -
boolean
C0332268 (UMLS CUI [1,1])
C0560841 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
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