ID

41187

Beschreibung

Utility of Endobronchial Ultrasound Guided Needle Biopsy in Early Stage Non- Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00832715

Link

https://clinicaltrials.gov/show/NCT00832715

Stichworte

Versionen (1)
  1. 08.07.20 08.07.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

8. Juli 2020

DOI

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Lizenz

Creative Commons BY-NC 4.0
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Eligibility Lung Cancer NCT00832715

Englisch

Eligibility Lung Cancer NCT00832715

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patient must be >/= 18 years old.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. patient must have ecog/zubrod status 0-2.
Beschreibung

ECOG performance status | Zubrod Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C3714786
3. patient must have proven or suspected nsclc (squamous cell, adenocarcinoma, or large cell) and be clinical stage i or ii, according to the 1998 staging system of the american joint commission on cancer for lung cancer (t1-3 n0, t1-2 n1).
Beschreibung

Non-Small Cell Lung Carcinoma TNM clinical staging | Non-Small Cell Lung Carcinoma Suspected | Squamous non-small cell lung cancer | Non-Small Cell Adenocarcinoma | Carcinoma, Large Cell

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C4509816
UMLS CUI [4]
C1335060
UMLS CUI [5]
C0206704
4. patient must be eligible for definitive surgical therapy for primary nsclc.
Beschreibung

Patient Appropriate Operative Surgical Procedure | Operative Surgical Procedure Non-Small Cell Lung Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0543467
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0007131
5. patient or the patient's legally acceptable representative must provide written informed consent prior to registration and any study-related procedures.
Beschreibung

Informed Consent | Informed Consent Patient Representative

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
6. if the patient is a survivor of a prior invasive cancer, all of the following criteria must apply: a. patient has undergone potentially curative therapy for all prior malignancies. b. no evidence of active / recurrent disease.
Beschreibung

Survivors Invasive Malignant Neoplasm | Inclusion criteria All Fulfill | Curative treatment Malignant Neoplasms | Disease Absent | Recurrent disease Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0206194
UMLS CUI [1,2]
C0677898
UMLS CUI [2,1]
C1512693
UMLS CUI [2,2]
C0444868
UMLS CUI [2,3]
C1550543
UMLS CUI [3,1]
C1273390
UMLS CUI [3,2]
C0006826
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0277556
UMLS CUI [5,2]
C0332197
7. all females of childbearing age must have a negative pregnancy test before beginning the study.
Beschreibung

Childbearing Potential Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient has received prior chemotherapy or radiotherapy for this cancer.
Beschreibung

Prior Chemotherapy Malignant Neoplasm | Prior Radiation Therapy Malignant Neoplasm

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0006826
2. patient is considered a poor risk for surgery due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
Beschreibung

Low risk Operative Surgical Procedure | Systemic disease Non-Malignant | Cardiovascular Diseases | Kidney Diseases

Datentyp

boolean

Alias
UMLS CUI [1,1]
C5201228
UMLS CUI [1,2]
C0543467
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C1518371
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0022658
3. patient has contraindication to either endobronchial ultrasound or mediastinoscopy such as: history of bleeding diathesis, latex allergy, mediastinoscopy, mediastinal nodal resection, tracheostomy.
Beschreibung

Medical contraindication Endobronchial ultrasound | Medical contraindication Mediastinoscopy | Bleeding tendency | Latex allergy | History of Mediastinoscopy | Excision of mediastinal lymph node | Tracheostomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C3160856
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0025065
UMLS CUI [3]
C1458140
UMLS CUI [4]
C0577628
UMLS CUI [5,1]
C0262926
UMLS CUI [5,2]
C0025065
UMLS CUI [6]
C0193872
UMLS CUI [7]
C0040590
4. patients malignancy consistent with well differentiated (carcinoid) neuroendocrine histology.
Beschreibung

Malignant Neoplasm Consistent with Neuroendocrine Differentiation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C1709218
5. patient has two separate same histology lung tumors (where the question of two separate primaries or metastatic disease makes definitive clinical staging inaccurate).
Beschreibung

Lung Neoplasms Quantity Separate | Histology Same | TNM clinical staging Inaccurate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024121
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0443299
UMLS CUI [2,1]
C0344441
UMLS CUI [2,2]
C0445247
UMLS CUI [3,1]
C3258246
UMLS CUI [3,2]
C0443236
6. females who are pregnant and/or lactating.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Lung Cancer NCT00832715

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patient must be >/= 18 years old.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status | Zubrod Performance Status
Item
2. patient must have ecog/zubrod status 0-2.
boolean
C1520224 (UMLS CUI [1])
C3714786 (UMLS CUI [2])
Non-Small Cell Lung Carcinoma TNM clinical staging | Non-Small Cell Lung Carcinoma Suspected | Squamous non-small cell lung cancer | Non-Small Cell Adenocarcinoma | Carcinoma, Large Cell
Item
3. patient must have proven or suspected nsclc (squamous cell, adenocarcinoma, or large cell) and be clinical stage i or ii, according to the 1998 staging system of the american joint commission on cancer for lung cancer (t1-3 n0, t1-2 n1).
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C4509816 (UMLS CUI [3])
C1335060 (UMLS CUI [4])
C0206704 (UMLS CUI [5])
Patient Appropriate Operative Surgical Procedure | Operative Surgical Procedure Non-Small Cell Lung Carcinoma
Item
4. patient must be eligible for definitive surgical therapy for primary nsclc.
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
Informed Consent | Informed Consent Patient Representative
Item
5. patient or the patient's legally acceptable representative must provide written informed consent prior to registration and any study-related procedures.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Survivors Invasive Malignant Neoplasm | Inclusion criteria All Fulfill | Curative treatment Malignant Neoplasms | Disease Absent | Recurrent disease Absent
Item
6. if the patient is a survivor of a prior invasive cancer, all of the following criteria must apply: a. patient has undergone potentially curative therapy for all prior malignancies. b. no evidence of active / recurrent disease.
boolean
C0206194 (UMLS CUI [1,1])
C0677898 (UMLS CUI [1,2])
C1512693 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
C1550543 (UMLS CUI [2,3])
C1273390 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0277556 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Childbearing Potential Pregnancy test negative
Item
7. all females of childbearing age must have a negative pregnancy test before beginning the study.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Malignant Neoplasm | Prior Radiation Therapy Malignant Neoplasm
Item
1. patient has received prior chemotherapy or radiotherapy for this cancer.
boolean
C1514457 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
Low risk Operative Surgical Procedure | Systemic disease Non-Malignant | Cardiovascular Diseases | Kidney Diseases
Item
2. patient is considered a poor risk for surgery due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
boolean
C5201228 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2,1])
C1518371 (UMLS CUI [2,2])
C0007222 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
Medical contraindication Endobronchial ultrasound | Medical contraindication Mediastinoscopy | Bleeding tendency | Latex allergy | History of Mediastinoscopy | Excision of mediastinal lymph node | Tracheostomy
Item
3. patient has contraindication to either endobronchial ultrasound or mediastinoscopy such as: history of bleeding diathesis, latex allergy, mediastinoscopy, mediastinal nodal resection, tracheostomy.
boolean
C1301624 (UMLS CUI [1,1])
C3160856 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0025065 (UMLS CUI [2,2])
C1458140 (UMLS CUI [3])
C0577628 (UMLS CUI [4])
C0262926 (UMLS CUI [5,1])
C0025065 (UMLS CUI [5,2])
C0193872 (UMLS CUI [6])
C0040590 (UMLS CUI [7])
Malignant Neoplasm Consistent with Neuroendocrine Differentiation
Item
4. patients malignancy consistent with well differentiated (carcinoid) neuroendocrine histology.
boolean
C0006826 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C1709218 (UMLS CUI [1,3])
Lung Neoplasms Quantity Separate | Histology Same | TNM clinical staging Inaccurate
Item
5. patient has two separate same histology lung tumors (where the question of two separate primaries or metastatic disease makes definitive clinical staging inaccurate).
boolean
C0024121 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0443299 (UMLS CUI [1,3])
C0344441 (UMLS CUI [2,1])
C0445247 (UMLS CUI [2,2])
C3258246 (UMLS CUI [3,1])
C0443236 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
6. females who are pregnant and/or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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