ID

13025

Description

Prognostic Study of Metastases in Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Can Be Removed by Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT00003901

Link

https://clinicaltrials.gov/show/NCT00003901

Keywords

  1. 1/12/16 1/12/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 12, 2016

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Lung Cancer NCT00003901

Eligibility Lung Cancer NCT00003901

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patient must be ≥ 18 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. patient must have ecog/zubrod status < 3.
Description

ecog performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
3. patient must have clinically resectable, nsclc (squamous cell, adenocarcinoma, or large cell) and be clinical stage i, iia, iib or iiia, according to the 1998 staging system of the american joint commission on cancer for lung cancer.
Description

Non Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007131
4. patient must have n1 or n2 disease. note: patient must undergo mediastinoscopy if preoperative studies suggest n3 disease.
Description

Tumor Stage N

Data type

boolean

Alias
UMLS CUI [1]
C1300072
5. patient must have a pathologic diagnosis (pre-operative or intra-operative) of nsclc prior to registration.
Description

pathologic diagnosis

Data type

boolean

Alias
UMLS CUI [1]
C1521733
6. patient must be anticipated to have a thoracotomy with the intention of a curative resection for primary nsclc. note: the preoperative assessment of resectability should, at a minimum, include a ct scan of the chest and upper abdomen, including the adrenal glands, within 60 days prior to registration.
Description

curable resection

Data type

boolean

Alias
UMLS CUI [1]
C0728940
7. patient must be medically fit for surgery.
Description

medically fit

Data type

boolean

Alias
UMLS CUI [1]
C0018759
8. patient must be a candidate for complete resection of the carcinoma via pneumonectomy, bilobectomy, lobectomy, or anatomic segmentectomy with or without sleeve resection.
Description

complete resection

Data type

boolean

Alias
UMLS CUI [1]
C0728940
9. patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study-related procedures.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
10. patient must be available for follow-up.
Description

patient must be available for follow-up.

Data type

boolean

Alias
UMLS CUI [1]
C1321605
11. if the patient is a survivor of a prior cancer, all of the following criteria must apply: 1. patient has undergone potentially curative therapy for all prior malignancies, 2. no evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone), 3. patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.
Description

Prior Malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient has evidence of pleural effusion by physical assessment, lateral chest x-ray, or by chest ct scan.
Description

pleural effusion

Data type

boolean

Alias
UMLS CUI [1]
C0032227
2. patient has had ipsilateral thoracotomy or thoracoscopy within the past 5 years.
Description

thoracotomy or thoracoscopy

Data type

boolean

Alias
UMLS CUI [1]
C0039991
UMLS CUI [2]
C0039989
3. patient has received prior chemotherapy or radiotherapy for this cancer.
Description

chemotherapy or radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
4. patient is considered a poor surgical risk due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
5. patient for whom the surgeon plans to perform only a wedge resection for treatment.
Description

wedge resection

Data type

boolean

Alias
UMLS CUI [1]
C0728940

Similar models

Eligibility Lung Cancer NCT00003901

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patient must be ≥ 18 years old.
boolean
C0001779 (UMLS CUI [1])
ecog performance status
Item
2. patient must have ecog/zubrod status < 3.
boolean
C1520224 (UMLS CUI [1])
Non Small Cell Lung Carcinoma
Item
3. patient must have clinically resectable, nsclc (squamous cell, adenocarcinoma, or large cell) and be clinical stage i, iia, iib or iiia, according to the 1998 staging system of the american joint commission on cancer for lung cancer.
boolean
C0007131 (UMLS CUI [1])
Tumor Stage N
Item
4. patient must have n1 or n2 disease. note: patient must undergo mediastinoscopy if preoperative studies suggest n3 disease.
boolean
C1300072 (UMLS CUI [1])
pathologic diagnosis
Item
5. patient must have a pathologic diagnosis (pre-operative or intra-operative) of nsclc prior to registration.
boolean
C1521733 (UMLS CUI [1])
curable resection
Item
6. patient must be anticipated to have a thoracotomy with the intention of a curative resection for primary nsclc. note: the preoperative assessment of resectability should, at a minimum, include a ct scan of the chest and upper abdomen, including the adrenal glands, within 60 days prior to registration.
boolean
C0728940 (UMLS CUI [1])
medically fit
Item
7. patient must be medically fit for surgery.
boolean
C0018759 (UMLS CUI [1])
complete resection
Item
8. patient must be a candidate for complete resection of the carcinoma via pneumonectomy, bilobectomy, lobectomy, or anatomic segmentectomy with or without sleeve resection.
boolean
C0728940 (UMLS CUI [1])
informed consent
Item
9. patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study-related procedures.
boolean
C0021430 (UMLS CUI [1])
patient must be available for follow-up.
Item
10. patient must be available for follow-up.
boolean
C1321605 (UMLS CUI [1])
Prior Malignancy
Item
11. if the patient is a survivor of a prior cancer, all of the following criteria must apply: 1. patient has undergone potentially curative therapy for all prior malignancies, 2. no evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone), 3. patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.
boolean
C0006826 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pleural effusion
Item
1. patient has evidence of pleural effusion by physical assessment, lateral chest x-ray, or by chest ct scan.
boolean
C0032227 (UMLS CUI [1])
thoracotomy or thoracoscopy
Item
2. patient has had ipsilateral thoracotomy or thoracoscopy within the past 5 years.
boolean
C0039991 (UMLS CUI [1])
C0039989 (UMLS CUI [2])
chemotherapy or radiotherapy
Item
3. patient has received prior chemotherapy or radiotherapy for this cancer.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
comorbidity
Item
4. patient is considered a poor surgical risk due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
boolean
C0009488 (UMLS CUI [1])
wedge resection
Item
5. patient for whom the surgeon plans to perform only a wedge resection for treatment.
boolean
C0728940 (UMLS CUI [1])

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