ID

12833

Beskrivning

Hypofractionated Radiotherapy Post-Lumpectomy in Women With Node Negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00156052

Länk

https://clinicaltrials.gov/show/NCT00156052

Nyckelord

Versioner (1)
  1. 2015-12-29 2015-12-29 -
Uppladdad den

29 december 2015

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00156052

Engelsk

Eligibility Breast Cancer NCT00156052

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. the female patient has a histological diagnosis of invasive carcinoma of the breast, and no evidence of metastatic disease.
Beskrivning

1. the female patient has a histological diagnosis of invasive carcinoma of the breast, and no evidence of metastatic disease.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0445092
2. has had a lumpectomy (including segmental resection and partial mastectomy), that is, surgical excision of the tumour with a rim of normal tissue.
Beskrivning

2. has had a lumpectomy (including segmental resection and partial mastectomy), that is, surgical excision of the tumour with a rim of normal tissue.

Datatyp

boolean

Alias
UMLS CUI [1]
C0851238
3. patient has not had an axillary dissection, or for patients who have had an axillary dissection, all nodes are negative for metastatic disease.
Beskrivning

3. patient has not had an axillary dissection, or for patients who have had an axillary dissection, all nodes are negative for metastatic disease.

Datatyp

boolean

Alias
UMLS CUI [1]
C0193867
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. tumour greater than 5 cm in greatest diameter on pathological examination.
Beskrivning

1. tumour greater than 5 cm in greatest diameter on pathological examination.

Datatyp

boolean

Alias
UMLS CUI [1]
C0475440
2. the presence of invasive or intraductal (noninvasive) breast cancer involving the surgical margins.
Beskrivning

2. the presence of invasive or intraductal (noninvasive) breast cancer involving the surgical margins.

Datatyp

boolean

Alias
UMLS CUI [1]
C0808133
3. clinical evidence prior to surgery of infiltration of the skin of the involved breast such as edema, ulceration, or fixation of the tumour to underlying muscle, or inflammatory breast cancer.
Beskrivning

3. clinical evidence prior to surgery of infiltration of the skin of the involved breast such as edema, ulceration, or fixation of the tumour to underlying muscle, or inflammatory breast cancer.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0241076
UMLS CUI [1,2]
C0006141
UMLS CUI [2]
C0278601
4. bilateral malignancy of the breast (synchronous or metachronous).
Beskrivning

4. bilateral malignancy of the breast (synchronous or metachronous).

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677861
UMLS CUI [1,2]
C0006141
5. more than one primary invasive tumour in the same breast.
Beskrivning

5. more than one primary invasive tumour in the same breast.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0205092
UMLS CUI [1,3]
C0443302
6. previous surgery for breast cancer.
Beskrivning

6. previous surgery for breast cancer.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3714726
UMLS CUI [1,3]
C0920424
7. pathological status of axilla is unknown.
Beskrivning

7. pathological status of axilla is unknown.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0443276
UMLS CUI [1,2]
C0004454
8. status for adjuvant systemic therapy not determined.
Beskrivning

8. status for adjuvant systemic therapy not determined.

Datatyp

boolean

Alias
UMLS CUI [1]
C1636177
9. for patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 16 weeks of last surgical procedure on the breast.
Beskrivning

9. for patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 16 weeks of last surgical procedure on the breast.

Datatyp

boolean

Alias
UMLS CUI [1]
C3846110
10. for patients treated with adjuvant chemotherapy: unable to commence radiation therapy within 8 weeks of the last dose of chemotherapy.
Beskrivning

10. for patients treated with adjuvant chemotherapy: unable to commence radiation therapy within 8 weeks of the last dose of chemotherapy.

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
11. serious nonmalignant disease (eg. cardiovascular, renal, etc.) which would preclude surgical or radiation treatment.
Beskrivning

11. serious nonmalignant disease (eg. cardiovascular, renal, etc.) which would preclude surgical or radiation treatment.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0852649
12. currently pregnant or lactating.
Beskrivning

12. currently pregnant or lactating.

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
13. breast deemed too large to permit satisfactory radiation (ie. separation > 25 cm).
Beskrivning

13. breast deemed too large to permit satisfactory radiation (ie. separation > 25 cm).

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0541812
14. previous concomitant malignancies of any type except squamous, or basal cell carcinomas of the skin, or carcinoma in situ of the cervix which have been effectively treated.
Beskrivning

14. previous concomitant malignancies of any type except squamous, or basal cell carcinomas of the skin, or carcinoma in situ of the cervix which have been effectively treated.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0006826
15. geographic inaccessibility for follow-up.
Beskrivning

15. geographic inaccessibility for follow-up.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0814423
UMLS CUI [1,2]
C1522577
16. psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.
Beskrivning

16. psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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Similar models

Eligibility Breast Cancer NCT00156052

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
invasive breast carcinoma
Item
1. the female patient has a histological diagnosis of invasive carcinoma of the breast, and no evidence of metastatic disease.
boolean
C0853879 (UMLS CUI [1,1])
C0445092 (UMLS CUI [1,2])
lumpectomy
Item
2. has had a lumpectomy (including segmental resection and partial mastectomy), that is, surgical excision of the tumour with a rim of normal tissue.
boolean
C0851238 (UMLS CUI [1])
negative axillary dissection
Item
3. patient has not had an axillary dissection, or for patients who have had an axillary dissection, all nodes are negative for metastatic disease.
boolean
C0193867 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
tumor size
Item
1. tumour greater than 5 cm in greatest diameter on pathological examination.
boolean
C0475440 (UMLS CUI [1])
breast cancer involving surgical margins
Item
2. the presence of invasive or intraductal (noninvasive) breast cancer involving the surgical margins.
boolean
C0808133 (UMLS CUI [1])
infiltration of the skin
Item
3. clinical evidence prior to surgery of infiltration of the skin of the involved breast such as edema, ulceration, or fixation of the tumour to underlying muscle, or inflammatory breast cancer.
boolean
C0241076 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C0278601 (UMLS CUI [2])
bilateral malignancy
Item
4. bilateral malignancy of the breast (synchronous or metachronous).
boolean
C0677861 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
several primary invasive tumors
Item
5. more than one primary invasive tumour in the same breast.
boolean
C0677930 (UMLS CUI [1,1])
C0205092 (UMLS CUI [1,2])
C0443302 (UMLS CUI [1,3])
previous breast cancer surgery
Item
6. previous surgery for breast cancer.
boolean
C0087111 (UMLS CUI [1,1])
C3714726 (UMLS CUI [1,2])
C0920424 (UMLS CUI [1,3])
unknown pathological status of axilla
Item
7. pathological status of axilla is unknown.
boolean
C0443276 (UMLS CUI [1,1])
C0004454 (UMLS CUI [1,2])
unclear status for adjuvant systemic therapy
Item
8. status for adjuvant systemic therapy not determined.
boolean
C1636177 (UMLS CUI [1])
impossibility of radiation therapy after surgery
Item
9. for patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 16 weeks of last surgical procedure on the breast.
boolean
C3846110 (UMLS CUI [1])
impossibility of radiotherapy after chemotherapy
Item
10. for patients treated with adjuvant chemotherapy: unable to commence radiation therapy within 8 weeks of the last dose of chemotherapy.
boolean
C1522449 (UMLS CUI [1])
Contraindication to surgical or radiation treatment
Item
11. serious nonmalignant disease (eg. cardiovascular, renal, etc.) which would preclude surgical or radiation treatment.
boolean
C0009488 (UMLS CUI [1,1])
C0852649 (UMLS CUI [1,2])
pregnant or lactating
Item
12. currently pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
breast size problematic for radiation
Item
13. breast deemed too large to permit satisfactory radiation (ie. separation > 25 cm).
boolean
C1522449 (UMLS CUI [1,1])
C0541812 (UMLS CUI [1,2])
previous concomitant malignancies
Item
14. previous concomitant malignancies of any type except squamous, or basal cell carcinomas of the skin, or carcinoma in situ of the cervix which have been effectively treated.
boolean
C0009488 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
geographic inaccessibility
Item
15. geographic inaccessibility for follow-up.
boolean
C0814423 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
disorders limitting informed consent
Item
16. psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
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