Eligibility Breast Cancer NCT01266642

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StudyEvent: Eligibility
1. Eligibility Breast Cancer NCT01266642

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

DCIS Pathologic TNM stage | Invasive carcinoma of breast Early Pathologic TNM stage

Item

1. pathologically confirmed ductal carcinoma in situ of the breast or early invasive breast cancer defined as pathologic stage tis, t1, or t2, n0, n1mic, or n1a (pathologic staging of the axilla is required for all patients with invasive disease but is not required for patients with dcis only). (upfront pathologic stage cannot be assigned to patients treated with neoadjuvant chemotherapy. for such patients, the criteria for pathologic stage shall be applied to the initial clinical stage)

boolean

C0007124 (UMLS CUI [1,1])
C1319019 (UMLS CUI [1,2])
C0853879 (UMLS CUI [2,1])
C2363430 (UMLS CUI [2,2])
C1319019 (UMLS CUI [2,3])

Breast-Conserving Surgery

Item

2. treatment with breast conserving surgery.

boolean

C0917927 (UMLS CUI [1])

Negative Surgical Margin | DCIS Absent | Invasive carcinoma of breast Absent

Item

3. final surgical margins must be negative, defined as no evidence for ductal carcinoma in situ or invasive breast cancer touching the inked surgical margin. if the invasive or in situ breast cancer approaches within less than 1 mm of the final surgical margin, then a reexcision is strongly encouraged. lobular carcinoma in situ at the final surgical margin will be disregarded.

boolean

C1709157 (UMLS CUI [1])
C0007124 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0853879 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])

Age | Risk Breast cancer recurrent Ipsilateral | Age Related

Item

4. age 40 years or older. this age cutoff is justified because breast cancers in women under the age of 40 are known to have a significantly higher risk of ibtr presumably due to underlying biologic differences.

boolean

C0001779 (UMLS CUI [1])
C0035647 (UMLS CUI [2,1])
C0278493 (UMLS CUI [2,2])
C0441989 (UMLS CUI [2,3])
C0001779 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])

Gender

Item

5. female sex.

boolean

C0079399 (UMLS CUI [1])

Intention Treatment Whole breast

Item

6. attending radiation oncologist declares intention to treat the whole breast only and that a third radiation field to treat regional lymph nodes is not planned (radiation of the undissected level i/ii axilla with high tangents is allowed).

boolean

C0162425 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0457102 (UMLS CUI [1,3])

Cancer Other | Exception Breast Carcinoma | Treatment completed Cancer Other | Cancer Other Disease Free

Item

7. if the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer.

boolean

C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0580352 (UMLS CUI [3,1])
C1707251 (UMLS CUI [3,2])
C1707251 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0332296 (UMLS CUI [4,3])

Patients Enrollment Timespan | Breast-Conserving Surgery | Cytotoxic Chemotherapy

Item

8. patients must be enrolled on the trial within 12 weeks of the later of two dates: the final breast conserving surgical procedure or administration of the last cycle of cytotoxic chemotherapy.

boolean

C0030705 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
C0917927 (UMLS CUI [2])
C0677881 (UMLS CUI [3])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Breast Carcinoma TNM Breast tumor staging

Item

1. pathologic or clinical evidence for a stage t3 or t4 breast cancer.

boolean

C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])

Involvement with Axillary lymph nodes Quantity | Involvement with Infraclavicular lymph nodes Imaging | Involvement with Supraclavicular lymph node Imaging | Involvement with Internal Mammary Lymph Node Imaging

Item

2. pathologic evidence for involvement of 4 or more axillary lymph nodes, or imaging evidence of involvement of infraclavicular, supraclavicular, or internal mammary lymph nodes.

boolean

C1314939 (UMLS CUI [1,1])
C0729594 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1314939 (UMLS CUI [2,1])
C0229743 (UMLS CUI [2,2])
C0011923 (UMLS CUI [2,3])
C1314939 (UMLS CUI [3,1])
C0229730 (UMLS CUI [3,2])
C0011923 (UMLS CUI [3,3])
C1314939 (UMLS CUI [4,1])
C0229755 (UMLS CUI [4,2])
C0011923 (UMLS CUI [4,3])

Distant metastasis

Item

3. clinical or pathologic evidence for distant metastases.

boolean

C1269798 (UMLS CUI [1])

Prior diagnosis Invasive carcinoma of breast | Prior diagnosis DCIS

Item

4. any prior diagnosis of invasive or ductal carcinoma in situ breast cancer in either breast.

boolean

C0332132 (UMLS CUI [1,1])
C0853879 (UMLS CUI [1,2])
C0332132 (UMLS CUI [2,1])
C0007124 (UMLS CUI [2,2])

Bilateral breast cancer

Item

5. current diagnosis of bilateral breast cancer.

boolean

C0281267 (UMLS CUI [1])

Radiotherapy to breast | Radiotherapy to neck Lower | Radiotherapy to mediastinum

Item

6. history of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast.

boolean

C0948310 (UMLS CUI [1])
C1997944 (UMLS CUI [2,1])
C0441994 (UMLS CUI [2,2])
C4049191 (UMLS CUI [3])

Lacking Able to speak fluently English Language | Lacking Able to speak fluently Spanish Language

Item

7. patients not fluent in english or spanish. (the informed consent will be available in these two languages)

boolean

C0332268 (UMLS CUI [1,1])
C0564241 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C0564241 (UMLS CUI [2,2])
C0037750 (UMLS CUI [2,3])

Pregnancy

Item

8. patient is pregnant.

boolean

C0032961 (UMLS CUI [1])

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Eligibility Breast Cancer NCT01266642