ID

12996

Beskrivning

Combination Chemotherapy in Treating Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00003088

Länk

https://clinicaltrials.gov/show/NCT00003088

Nyckelord

Versioner (1)
  1. 2016-01-10 2016-01-10 -
Uppladdad den

10 januari 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00003088

Engelsk

Eligibility Breast Cancer NCT00003088

1 Formulär  
Criteria
Beskrivning

Criteria

1.1 patients with operable, histologically confirmed adenocarcinoma of the female breast and positive lymph nodes. node positivity may be determined by either an axillary node dissection or a positive sentinel node finding by immunohistochemistry or histology. this includes any patient with one or more positive lymph nodes whose tumors are t0, t1, 2 or 3 and n1, n2, mo. patients with metaplastic carcinoma are eligible. bilateral disease does not exclude patients from entry.
Beskrivning

Adenocarcinoma of breast, female, tumor stage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0001418
UMLS CUI [2]
C0079399
UMLS CUI [3]
C1300072
1.2 tumors that are locally advanced at diagnosis are not eligible. this is left to investigator judgment. patients with tumors fixed to the chest wall, peau d'orange skin changes, skin ulcerations, or clinical inflammatory changes (t4 disease) are excluded from this study. dermal lymphatic involvement noted on pathology without clinical inflammatory changes will not exclude a patient from this study.
Beskrivning

tumor stage

Datatyp

boolean

Alias
UMLS CUI [1]
C1300072
1.3 patients with any erp/pgr status are eligible.
Beskrivning

Hormone receptor status

Datatyp

boolean

Alias
UMLS CUI [1]
C0019929
2.1 <84 days from mastectomy or within 84 days of axillary dissection if the patient's most extensive breast surgery was a breast sparing procedure.
Beskrivning

mastectomy, axillary dissection

Datatyp

boolean

Alias
UMLS CUI [1]
C0024881
UMLS CUI [2]
C0193867
2.2 surgical resection margins - all tumor should be removed by either a modified radical mastectomy or a segmental mastectomy. node dissection: patients may have had either an axillary node dissection or sentinel lymph node biopsy before beginning treatment on protocol.
Beskrivning

Surgical procedures and node dissection

Datatyp

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C0024203
mastectomy: there should be no evidence of gross or microscopic tumor at the surgical resection margins noted in the final surgery or pathology reports for patients who have had a modified radical mastectomy. patients with close margins (tumor < 1 mm from margin) are eligible.
Beskrivning

surgical margins

Datatyp

boolean

Alias
UMLS CUI [1]
C0229985
segmental mastectomy (lumpectomy): although clear margins are preferable, dcis or lcis at the surgical resection margin will not render a patient who has undergone a segmental mastectomy ineligible for this study. invasive tumor at the final resection margin will render a patient ineligible.
Beskrivning

Surgical margins, DCIS, LCIS

Datatyp

boolean

Alias
UMLS CUI [1]
C0229985
UMLS CUI [2]
C0007124
UMLS CUI [3]
C0279563
2.3 no prior chemotherapy.
Beskrivning

chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
2.4 no prior radiation therapy for this malignancy. patients who received radiation to the breast for dcis are eligible. patients who have had segmental mastectomy will be treated with radiotherapy according to standard procedures in the treating physician's institution after completion of all chemotherapy. patients who have had modified radical mastectomy may also receive radiotherapy at the discretion of the treating physician according to institutional guidelines.
Beskrivning

radiation therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
2.5 patients may receive up to four weeks of tamoxifen therapy for this malignancy and still be eligible for study entry. patients who received tamoxifen for purposes of chemoprevention (e.g., breast cancer prevention trial) or for other indications (including previous breast cancer) are eligible. tamoxifen therapy should be discontinued before the patient is enrolled on this study.
Beskrivning

tamoxifen

Datatyp

boolean

Alias
UMLS CUI [1]
C0039286
3. age > 18. there is no upper age limit for enrollment on this study.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
granulocyte count > 1000/mm3
Beskrivning

granulocyte count

Datatyp

boolean

Alias
UMLS CUI [1]
C0857490
platelet count > 100,000/mm3
Beskrivning

platelet count

Datatyp

boolean

Alias
UMLS CUI [1]
C0005821
bilirubin within upper limits of normal
Beskrivning

bilirubin

Datatyp

boolean

Alias
UMLS CUI [1]
C1557209
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Similar models

Eligibility Breast Cancer NCT00003088

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Adenocarcinoma of breast, female, tumor stage
Item
1.1 patients with operable, histologically confirmed adenocarcinoma of the female breast and positive lymph nodes. node positivity may be determined by either an axillary node dissection or a positive sentinel node finding by immunohistochemistry or histology. this includes any patient with one or more positive lymph nodes whose tumors are t0, t1, 2 or 3 and n1, n2, mo. patients with metaplastic carcinoma are eligible. bilateral disease does not exclude patients from entry.
boolean
C0678222 (UMLS CUI [1,1])
C0001418 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
C1300072 (UMLS CUI [3])
tumor stage
Item
1.2 tumors that are locally advanced at diagnosis are not eligible. this is left to investigator judgment. patients with tumors fixed to the chest wall, peau d'orange skin changes, skin ulcerations, or clinical inflammatory changes (t4 disease) are excluded from this study. dermal lymphatic involvement noted on pathology without clinical inflammatory changes will not exclude a patient from this study.
boolean
C1300072 (UMLS CUI [1])
Hormone receptor status
Item
1.3 patients with any erp/pgr status are eligible.
boolean
C0019929 (UMLS CUI [1])
mastectomy, axillary dissection
Item
2.1 <84 days from mastectomy or within 84 days of axillary dissection if the patient's most extensive breast surgery was a breast sparing procedure.
boolean
C0024881 (UMLS CUI [1])
C0193867 (UMLS CUI [2])
Surgical procedures and node dissection
Item
2.2 surgical resection margins - all tumor should be removed by either a modified radical mastectomy or a segmental mastectomy. node dissection: patients may have had either an axillary node dissection or sentinel lymph node biopsy before beginning treatment on protocol.
boolean
C0543467 (UMLS CUI [1])
C0024203 (UMLS CUI [2])
surgical margins
Item
mastectomy: there should be no evidence of gross or microscopic tumor at the surgical resection margins noted in the final surgery or pathology reports for patients who have had a modified radical mastectomy. patients with close margins (tumor < 1 mm from margin) are eligible.
boolean
C0229985 (UMLS CUI [1])
Surgical margins, DCIS, LCIS
Item
segmental mastectomy (lumpectomy): although clear margins are preferable, dcis or lcis at the surgical resection margin will not render a patient who has undergone a segmental mastectomy ineligible for this study. invasive tumor at the final resection margin will render a patient ineligible.
boolean
C0229985 (UMLS CUI [1])
C0007124 (UMLS CUI [2])
C0279563 (UMLS CUI [3])
chemotherapy
Item
2.3 no prior chemotherapy.
boolean
C0392920 (UMLS CUI [1])
radiation therapy
Item
2.4 no prior radiation therapy for this malignancy. patients who received radiation to the breast for dcis are eligible. patients who have had segmental mastectomy will be treated with radiotherapy according to standard procedures in the treating physician's institution after completion of all chemotherapy. patients who have had modified radical mastectomy may also receive radiotherapy at the discretion of the treating physician according to institutional guidelines.
boolean
C1522449 (UMLS CUI [1])
tamoxifen
Item
2.5 patients may receive up to four weeks of tamoxifen therapy for this malignancy and still be eligible for study entry. patients who received tamoxifen for purposes of chemoprevention (e.g., breast cancer prevention trial) or for other indications (including previous breast cancer) are eligible. tamoxifen therapy should be discontinued before the patient is enrolled on this study.
boolean
C0039286 (UMLS CUI [1])
Age
Item
3. age > 18. there is no upper age limit for enrollment on this study.
boolean
C0001779 (UMLS CUI [1])
granulocyte count
Item
granulocyte count > 1000/mm3
boolean
C0857490 (UMLS CUI [1])
platelet count
Item
platelet count > 100,000/mm3
boolean
C0005821 (UMLS CUI [1])
bilirubin
Item
bilirubin within upper limits of normal
boolean
C1557209 (UMLS CUI [1])
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