ID

35029

Beschrijving

Tissue Procurement Protocol for Patients Undergoing Treatment for Early-Stage Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02455882

Link

https://clinicaltrials.gov/show/NCT02455882

Trefwoorden

Versies (1)
  1. 11-02-19 11-02-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

11 februari 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02455882

Engels

Eligibility Breast Cancer NCT02455882

1 Formulieren  
Criteria
Beschrijving

Criteria

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patients must have a primary invasive breast cancer with the primary tumor intact (t2-4, any n, any m). inflammatory breast cancer is permitted.
Beschrijving

Primary invasive malignant neoplasm of female breast | Primary tumor Intact TNM Breast tumor staging | Inflammatory Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C4076461
UMLS CUI [2,1]
C0677930
UMLS CUI [2,2]
C0205266
UMLS CUI [2,3]
C0474926
UMLS CUI [3]
C0278601
for the neoadjuvant cohort (group 1), the patient's clinical plan includes neoadjuvant systemic therapy (chemotherapy, hormonal therapy, and/or biologic therapy) prior to surgery on the breast.
Beschrijving

Neoadjuvant Therapy Systemic | Chemotherapy | Hormone Therapy | Biological treatment | Status pre- Operation on breast

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0279025
UMLS CUI [4]
C1531518
UMLS CUI [5,1]
C0332152
UMLS CUI [5,2]
C3714726
for the adjuvant cohort (group 2), the patient's clinical plan includes surgical resection of the primary breast mass followed by adjuvant chemotherapy (with or without endocrine therapy or biologic therapy such as trastuzumab).
Beschrijving

Excision Mass in breast Primary | Chemotherapy, Adjuvant | Hormone Therapy | Hormone Therapy Absent | Biological treatment | trastuzumab

Datatype

boolean

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C0024103
UMLS CUI [1,3]
C0205225
UMLS CUI [2]
C0085533
UMLS CUI [3]
C0279025
UMLS CUI [4,1]
C0279025
UMLS CUI [4,2]
C0332197
UMLS CUI [5]
C1531518
UMLS CUI [6]
C0728747
patients in the neoadjuvant cohort must have had mammography performed at the university of michigan, or outside film review prior to enrollment.
Beschrijving

Mammography

Datatype

boolean

Alias
UMLS CUI [1]
C0024671
all patients are required to sign an informed consent document regarding the experimental purpose of the research biopsies and serum banking, in accordance with the university of michigan irb standards.
Beschrijving

Informed Consent | Research Biopsy

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0035168
UMLS CUI [2,2]
C0005558
exclusion criteria - for the neoadjuvant cohort (group 1): tumors diagnosed by excisional biopsy, or incisional biopsy that does not leave at least 2 cm of measurable disease by physical examination, mammography, or ultrasound (with the exception of inflammatory breast cancer)
Beschrijving

Exclusion Criteria | Neoplasm Excision biopsy | Incisional biopsy | Measurable Disease Absent Physical Examination | Measurable Disease Absent Mammography | Measurable Disease Absent Ultrasonography | Exception Inflammatory Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0184921
UMLS CUI [3]
C0184922
UMLS CUI [4,1]
C1513041
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0031809
UMLS CUI [5,1]
C1513041
UMLS CUI [5,2]
C0332197
UMLS CUI [5,3]
C0024671
UMLS CUI [6,1]
C1513041
UMLS CUI [6,2]
C0332197
UMLS CUI [6,3]
C0041618
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0278601
for the adjuvant cohort (group 2): tumors diagnosed by excisional or incisional biopsy and which are not likely to have at least 2 cm of residual tumor remaining
Beschrijving

Exclusion Criteria | Neoplasms Excision biopsy | Neoplasms Incisional biopsy | Residual Tumor Size Unlikely

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0184921
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C0184922
UMLS CUI [4,1]
C0543478
UMLS CUI [4,2]
C0456389
UMLS CUI [4,3]
C0750558
patients must not have received any prior chemotherapy, hormonal therapy, or radiation therapy for their current breast cancer. patients who received tamoxifen or other agents for prevention of breast cancer may be included.
Beschrijving

Exclusion Criteria | Prior Chemotherapy Breast Carcinoma | Prior Hormone Therapy Breast Carcinoma | Prior radiation therapy Breast Carcinoma | Tamoxifen allowed | Preventive medication Breast Carcinoma allowed

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C1514460
UMLS CUI [3,2]
C0678222
UMLS CUI [4,1]
C0279134
UMLS CUI [4,2]
C0678222
UMLS CUI [5,1]
C0039286
UMLS CUI [5,2]
C0683607
UMLS CUI [6,1]
C1656259
UMLS CUI [6,2]
C0678222
UMLS CUI [6,3]
C0683607
patients with another active systemic malignancy within the past year.
Beschrijving

Exclusion Criteria | Cancer Other Systemic

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C1707251
UMLS CUI [2,2]
C0205373
entry criteria for patients with newly diagnosed locoregional or distant disease recurrence (who did not enroll at the time of initial adjuvant or neoadjuvant chemotherapy) (group 3)
Beschrijving

Locoregional Neoplasm Recurrence | Distant metastasis Recurrent

Datatype

boolean

Alias
UMLS CUI [1]
C0027643
UMLS CUI [2,1]
C1269798
UMLS CUI [2,2]
C2945760
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have been previously diagnosed with non-invasive or invasive breast cancer.
Beschrijving

Prior diagnosis Breast Carcinoma | Prior diagnosis Invasive carcinoma of breast

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332132
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0332132
UMLS CUI [2,2]
C0853879
patients must have been diagnosed with biopsy-proven recurrence of breast cancer at any site
Beschrijving

Breast cancer recurrent Biopsy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0278493
UMLS CUI [1,2]
C0005558
all patients are required to sign an informed consent document regarding the experimental purpose of the research biopsies and serum banking, in accordance with the university of michigan irb standards.
Beschrijving

Informed Consent | Research Biopsy

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0035168
UMLS CUI [2,2]
C0005558
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must not have received any chemotherapy, hormonal therapy, or radiation therapy for treatment of their recurrent breast cancer.
Beschrijving

Chemotherapy Breast cancer recurrent | Hormone Therapy Breast cancer recurrent | Therapeutic radiology procedure Breast cancer recurrent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0278493
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0278493
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0278493
patients must not have been diagnosed with another active systemic malignancy within the past year.
Beschrijving

Cancer Other Systemic

Datatype

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0205373
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Similar models

Eligibility Breast Cancer NCT02455882

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Primary invasive malignant neoplasm of female breast | Primary tumor Intact TNM Breast tumor staging | Inflammatory Breast Carcinoma
Item
all patients must have a primary invasive breast cancer with the primary tumor intact (t2-4, any n, any m). inflammatory breast cancer is permitted.
boolean
C4076461 (UMLS CUI [1])
C0677930 (UMLS CUI [2,1])
C0205266 (UMLS CUI [2,2])
C0474926 (UMLS CUI [2,3])
C0278601 (UMLS CUI [3])
Neoadjuvant Therapy Systemic | Chemotherapy | Hormone Therapy | Biological treatment | Status pre- Operation on breast
Item
for the neoadjuvant cohort (group 1), the patient's clinical plan includes neoadjuvant systemic therapy (chemotherapy, hormonal therapy, and/or biologic therapy) prior to surgery on the breast.
boolean
C0600558 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C1531518 (UMLS CUI [4])
C0332152 (UMLS CUI [5,1])
C3714726 (UMLS CUI [5,2])
Excision Mass in breast Primary | Chemotherapy, Adjuvant | Hormone Therapy | Hormone Therapy Absent | Biological treatment | trastuzumab
Item
for the adjuvant cohort (group 2), the patient's clinical plan includes surgical resection of the primary breast mass followed by adjuvant chemotherapy (with or without endocrine therapy or biologic therapy such as trastuzumab).
boolean
C0728940 (UMLS CUI [1,1])
C0024103 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0085533 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C0279025 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1531518 (UMLS CUI [5])
C0728747 (UMLS CUI [6])
Mammography
Item
patients in the neoadjuvant cohort must have had mammography performed at the university of michigan, or outside film review prior to enrollment.
boolean
C0024671 (UMLS CUI [1])
Informed Consent | Research Biopsy
Item
all patients are required to sign an informed consent document regarding the experimental purpose of the research biopsies and serum banking, in accordance with the university of michigan irb standards.
boolean
C0021430 (UMLS CUI [1])
C0035168 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
Exclusion Criteria | Neoplasm Excision biopsy | Incisional biopsy | Measurable Disease Absent Physical Examination | Measurable Disease Absent Mammography | Measurable Disease Absent Ultrasonography | Exception Inflammatory Breast Carcinoma
Item
exclusion criteria - for the neoadjuvant cohort (group 1): tumors diagnosed by excisional biopsy, or incisional biopsy that does not leave at least 2 cm of measurable disease by physical examination, mammography, or ultrasound (with the exception of inflammatory breast cancer)
boolean
C0680251 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C0184921 (UMLS CUI [2,2])
C0184922 (UMLS CUI [3])
C1513041 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0031809 (UMLS CUI [4,3])
C1513041 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0024671 (UMLS CUI [5,3])
C1513041 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0041618 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0278601 (UMLS CUI [7,2])
Exclusion Criteria | Neoplasms Excision biopsy | Neoplasms Incisional biopsy | Residual Tumor Size Unlikely
Item
for the adjuvant cohort (group 2): tumors diagnosed by excisional or incisional biopsy and which are not likely to have at least 2 cm of residual tumor remaining
boolean
C0680251 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C0184921 (UMLS CUI [2,2])
C0027651 (UMLS CUI [3,1])
C0184922 (UMLS CUI [3,2])
C0543478 (UMLS CUI [4,1])
C0456389 (UMLS CUI [4,2])
C0750558 (UMLS CUI [4,3])
Exclusion Criteria | Prior Chemotherapy Breast Carcinoma | Prior Hormone Therapy Breast Carcinoma | Prior radiation therapy Breast Carcinoma | Tamoxifen allowed | Preventive medication Breast Carcinoma allowed
Item
patients must not have received any prior chemotherapy, hormonal therapy, or radiation therapy for their current breast cancer. patients who received tamoxifen or other agents for prevention of breast cancer may be included.
boolean
C0680251 (UMLS CUI [1])
C1514457 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1514460 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C0279134 (UMLS CUI [4,1])
C0678222 (UMLS CUI [4,2])
C0039286 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C1656259 (UMLS CUI [6,1])
C0678222 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
Exclusion Criteria | Cancer Other Systemic
Item
patients with another active systemic malignancy within the past year.
boolean
C0680251 (UMLS CUI [1])
C1707251 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
Locoregional Neoplasm Recurrence | Distant metastasis Recurrent
Item
entry criteria for patients with newly diagnosed locoregional or distant disease recurrence (who did not enroll at the time of initial adjuvant or neoadjuvant chemotherapy) (group 3)
boolean
C0027643 (UMLS CUI [1])
C1269798 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
Item Group
C1512693 (UMLS CUI)
Prior diagnosis Breast Carcinoma | Prior diagnosis Invasive carcinoma of breast
Item
patients must have been previously diagnosed with non-invasive or invasive breast cancer.
boolean
C0332132 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0332132 (UMLS CUI [2,1])
C0853879 (UMLS CUI [2,2])
Breast cancer recurrent Biopsy
Item
patients must have been diagnosed with biopsy-proven recurrence of breast cancer at any site
boolean
C0278493 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
Informed Consent | Research Biopsy
Item
all patients are required to sign an informed consent document regarding the experimental purpose of the research biopsies and serum banking, in accordance with the university of michigan irb standards.
boolean
C0021430 (UMLS CUI [1])
C0035168 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Breast cancer recurrent | Hormone Therapy Breast cancer recurrent | Therapeutic radiology procedure Breast cancer recurrent
Item
patients must not have received any chemotherapy, hormonal therapy, or radiation therapy for treatment of their recurrent breast cancer.
boolean
C0392920 (UMLS CUI [1,1])
C0278493 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0278493 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0278493 (UMLS CUI [3,2])
Cancer Other Systemic
Item
patients must not have been diagnosed with another active systemic malignancy within the past year.
boolean
C1707251 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
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