Information:
Fel:
ID
13023
Beskrivning
Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00003831
Länk
https://clinicaltrials.gov/show/NCT00003831
Nyckelord
Versioner (1)
- 2016-01-12 2016-01-12 -
Rättsinnehavare
CC BY-NC 3.0
Uppladdad den
12 januari 2016
DOI
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Licens
Creative Commons BY-NC 3.0
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Eligibility Lung Cancer NCT00003831
Eligibility Lung Cancer NCT00003831
- StudyEvent: Eligibility
Similar models
Eligibility Lung Cancer NCT00003831
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
age
Item
1. patient must be ≥18 years of age.
boolean
C0001779 (UMLS CUI [1])
ecog performance status
Item
2. patient must have an ecog/zubrod performance status of ≤ 3.
boolean
C1520224 (UMLS CUI [1])
non small cell lung cancer
Item
3. patient must have tissue diagnosis of a clinically resectable t1 or t2, n0 or non-hilar n1, m0 nsclc (squamous cell carcinoma, large cell carcinoma or adenocarcinoma including bronchoalveolar carcinoma) established prior to randomization. note: a patient without a pre-operative tissue diagnosis, but with clinically suspected nsclc that fits the above criteria is eligible provided the tissue diagnosis is confirmed intraoperatively.
boolean
C0007131 (UMLS CUI [1])
imaging
Item
4. patient must have pre-operative imaging procedure, ct scan of the chest and upper abdomen to include liver and adrenal glands to determine eligibility, within 60 days of the date of the pulmonary resection.
boolean
C0011923 (UMLS CUI [1])
mediastinal adenopathy
Item
5. patient that has not had a mediastinoscopy should have no mediastinal adenopathy on the ct of the chest defined as no lymph node > 1 cm in the shortest axis.
boolean
C1386346 (UMLS CUI [1])
complete resection
Item
6. patient is a candidate for a complete resection of the carcinoma via pneumonectomy,lobectomy, bilobectomy, or anatomic segmentectomy with or without sleeve resection,as noted in the surgical plan.
boolean
C0728940 (UMLS CUI [1])
informed consent
Item
7. patient, or patient's legally acceptable representative, must provide a signed and dated z0030-specific written informed consent prior to registration and any study-related procedures.
boolean
C0021430 (UMLS CUI [1])
prior malignancies
Item
8. if patient is a survivor of a prior cancer, the following criteria are met: 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])
right-sided lesions
Item
1. patient with right-sided lesions must have at least nodal stations #2r, 4r, 7 and 10 r examined. if the nodes are found, they must be sampled and proven negative by frozen section.
text
C0024204 (UMLS CUI [1])
left-sided lesions
Item
2. patient with left-sided lesions must have at least nodal stations #5, 6, 7 and 10l examined. if the nodes are found, they must be sampled and proven negative by frozen section.
text
C0024204 (UMLS CUI [1])
suspicious mediastinal or hilar nodes
Item
3. any other suspicious mediastinal or hilar nodes must be sampled and proven negative by frozen section. levels 2, 4 and 7 need not be re-sampled if they were sampled at a mediastinoscopy done within 60 days of thehoracotomy.
text
C0024204 (UMLS CUI [1])
Tumor status N
Item
1. patient has n2 disease determined at pre-operative mediastinoscopy or on sampling.
boolean
C1300072 (UMLS CUI [1])
Tumor stage T
Item
2. patient has t3 or t4 tumor.
boolean
C1300072 (UMLS CUI [1])
wedge resection
Item
3. patient is having only a wedge resection performed for treatment.
boolean
C0728940 (UMLS CUI [1])
chemotherapy or radiotherapy
Item
4. patient has received prior chemotherapy or radiotherapy for this cancer.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C1522449 (UMLS CUI [2])