ID

16777

Description

Follow-Up Study of Patients Who Have Undergone Surgery for Stage I, Stage II, or Stage III Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00560365

Link

https://clinicaltrials.gov/show/NCT00560365

Keywords

Versions (1)
  1. 8/7/16 8/7/16 -
Uploaded on

August 7, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00560365

English

Eligibility Colorectal Cancer NCT00560365

1 forms  
Criteria
Description

Criteria

diagnosis of primary colorectal cancer
Description

Colorectal Carcinoma Primary

Data type

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C0205225
stage i-iii disease
Description

TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C3258246
have undergone curative resection (i.e., no residual disease [r0])
Description

Excision Curative | Residual Tumor

Data type

boolean

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C1276305
UMLS CUI [2]
C0543478
microscopically clear margins
Description

Clear Surgical Margin Microscopic

Data type

boolean

Alias
UMLS CUI [1,1]
C1709157
UMLS CUI [1,2]
C0205288
complete normal colonic imaging pre-operatively (or post-operatively if unable to view complete colon pre-operatively) by colonoscopy, barium enema, ct pneumocolon, or virtual colonoscopy
Description

Diagnostic Imaging Colon Preoperative Complete | Diagnostic Imaging Colon Postoperative Complete | colonoscopy | Lower gastrointestinal tract contrast procedure | Computed Tomographic Colonography | Virtual CT colonoscopy

Data type

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0009368
UMLS CUI [1,3]
C0445204
UMLS CUI [1,4]
C0205197
UMLS CUI [2,1]
C0011923
UMLS CUI [2,2]
C0009368
UMLS CUI [2,3]
C0445204
UMLS CUI [2,4]
C0032790
UMLS CUI [2,5]
C0205197
UMLS CUI [3]
C0009378
UMLS CUI [4]
C0203075
UMLS CUI [5]
C0935912
UMLS CUI [6]
C1635173
post-operative blood cea ≤ 10 ng/ml (if the normal range is ≤ 5 ng/ml) or < 2 times upper limit of normal (if normal range is > 5 ng/ml)
Description

Carcinoembryonic antigen measurement Blood Postoperative

Data type

boolean

Alias
UMLS CUI [1,1]
C0201933
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0032790
for patients undergoing adjuvant therapy, cea should be measured after completion of chemotherapy
Description

Adjuvant therapy | Carcinoembryonic antigen measurement Post Chemotherapy Complete

Data type

boolean

Alias
UMLS CUI [1]
C0677850
UMLS CUI [2,1]
C0201933
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0392920
UMLS CUI [2,4]
C0205197
has completed primary curative treatment, as deemed by hospital clinician
Description

curative treatment Primary Complete

Data type

boolean

Alias
UMLS CUI [1,1]
C1273390
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0205197
patients awaiting stoma closure allowed
Description

Surgical closure of stoma Patient awaiting procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0185019
UMLS CUI [1,2]
C0554950
no evidence of metastatic disease on pre- or post-operative liver ct scan (or ultrasound) and chest ct scan (or chest x-ray)
Description

Neoplasm Metastasis Evidence | Computed Tomography (CT) of Liver Preoperative | Computed Tomography (CT) of Liver Postoperative | Ultrasonography of liver Preoperative | Ultrasonography of liver Postoperative | Chest CT Preoperative | Chest CT Postoperative | chest X-ray Preoperative | chest X-ray Postoperative

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C3887511
UMLS CUI [2,1]
C0412621
UMLS CUI [2,2]
C0445204
UMLS CUI [3,1]
C0412621
UMLS CUI [3,2]
C0032790
UMLS CUI [4,1]
C0412534
UMLS CUI [4,2]
C0445204
UMLS CUI [5,1]
C0412534
UMLS CUI [5,2]
C0032790
UMLS CUI [6,1]
C0202823
UMLS CUI [6,2]
C0445204
UMLS CUI [7,1]
C0202823
UMLS CUI [7,2]
C0032790
UMLS CUI [8,1]
C0039985
UMLS CUI [8,2]
C0445204
UMLS CUI [9,1]
C0039985
UMLS CUI [9,2]
C0032790
no diagnosis of familial adenomatous polyposis (fap) or dominantly inherited colon cancer
Description

Adenomatous Polyposis Coli | Colon Carcinoma dominant inheritance

Data type

boolean

Alias
UMLS CUI [1]
C0032580
UMLS CUI [2,1]
C0699790
UMLS CUI [2,2]
C0678942
patient characteristics:
Description

Patient Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
no concurrent serious illness
Description

Illness Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
history of other carcinoma allowed provided primary treatment has been completed, there is no evidence of recurrent disease, and there is no follow-up that conflicts with study follow-up
Description

Carcinoma First line treatment Complete | Recurrent disease Evidence | follow-up Interferes with Clinical Study Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0007097
UMLS CUI [1,2]
C1708063
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C3887511
UMLS CUI [3,1]
C1522577
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C3274571
prior concurrent therapy:
Description

Prior Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514463
see disease characteristics
Description

disease characteristic

Data type

boolean

Alias
UMLS CUI [1]
C0599878
pre-operative radiotherapy or chemoradiotherapy for rectal cancer allowed provided curative resection has been achieved
Description

Rectal Carcinoma Therapeutic radiology procedure Preoperative | Rectal Carcinoma Chemoradiotherapy Preoperative | Excision Curative Complete

Data type

boolean

Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0445204
UMLS CUI [2,1]
C0007113
UMLS CUI [2,2]
C0436307
UMLS CUI [2,3]
C0445204
UMLS CUI [3,1]
C0728940
UMLS CUI [3,2]
C1276305
UMLS CUI [3,3]
C0205197
no concurrent participation in a primary treatment clinical trial with conflicting follow-up requirements
Description

Study Subject Participation Status Interferes with Clinical Study Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C3274571
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Similar models

Eligibility Colorectal Cancer NCT00560365

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Colorectal Carcinoma Primary
Item
diagnosis of primary colorectal cancer
boolean
C0009402 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
TNM clinical staging
Item
stage i-iii disease
boolean
C3258246 (UMLS CUI [1])
Excision Curative | Residual Tumor
Item
have undergone curative resection (i.e., no residual disease [r0])
boolean
C0728940 (UMLS CUI [1,1])
C1276305 (UMLS CUI [1,2])
C0543478 (UMLS CUI [2])
Clear Surgical Margin Microscopic
Item
microscopically clear margins
boolean
C1709157 (UMLS CUI [1,1])
C0205288 (UMLS CUI [1,2])
Diagnostic Imaging Colon Preoperative Complete | Diagnostic Imaging Colon Postoperative Complete | colonoscopy | Lower gastrointestinal tract contrast procedure | Computed Tomographic Colonography | Virtual CT colonoscopy
Item
complete normal colonic imaging pre-operatively (or post-operatively if unable to view complete colon pre-operatively) by colonoscopy, barium enema, ct pneumocolon, or virtual colonoscopy
boolean
C0011923 (UMLS CUI [1,1])
C0009368 (UMLS CUI [1,2])
C0445204 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
C0011923 (UMLS CUI [2,1])
C0009368 (UMLS CUI [2,2])
C0445204 (UMLS CUI [2,3])
C0032790 (UMLS CUI [2,4])
C0205197 (UMLS CUI [2,5])
C0009378 (UMLS CUI [3])
C0203075 (UMLS CUI [4])
C0935912 (UMLS CUI [5])
C1635173 (UMLS CUI [6])
Carcinoembryonic antigen measurement Blood Postoperative
Item
post-operative blood cea ≤ 10 ng/ml (if the normal range is ≤ 5 ng/ml) or < 2 times upper limit of normal (if normal range is > 5 ng/ml)
boolean
C0201933 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0032790 (UMLS CUI [1,3])
Adjuvant therapy | Carcinoembryonic antigen measurement Post Chemotherapy Complete
Item
for patients undergoing adjuvant therapy, cea should be measured after completion of chemotherapy
boolean
C0677850 (UMLS CUI [1])
C0201933 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
C0205197 (UMLS CUI [2,4])
curative treatment Primary Complete
Item
has completed primary curative treatment, as deemed by hospital clinician
boolean
C1273390 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Surgical closure of stoma Patient awaiting procedure
Item
patients awaiting stoma closure allowed
boolean
C0185019 (UMLS CUI [1,1])
C0554950 (UMLS CUI [1,2])
Neoplasm Metastasis Evidence | Computed Tomography (CT) of Liver Preoperative | Computed Tomography (CT) of Liver Postoperative | Ultrasonography of liver Preoperative | Ultrasonography of liver Postoperative | Chest CT Preoperative | Chest CT Postoperative | chest X-ray Preoperative | chest X-ray Postoperative
Item
no evidence of metastatic disease on pre- or post-operative liver ct scan (or ultrasound) and chest ct scan (or chest x-ray)
boolean
C0027627 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0412621 (UMLS CUI [2,1])
C0445204 (UMLS CUI [2,2])
C0412621 (UMLS CUI [3,1])
C0032790 (UMLS CUI [3,2])
C0412534 (UMLS CUI [4,1])
C0445204 (UMLS CUI [4,2])
C0412534 (UMLS CUI [5,1])
C0032790 (UMLS CUI [5,2])
C0202823 (UMLS CUI [6,1])
C0445204 (UMLS CUI [6,2])
C0202823 (UMLS CUI [7,1])
C0032790 (UMLS CUI [7,2])
C0039985 (UMLS CUI [8,1])
C0445204 (UMLS CUI [8,2])
C0039985 (UMLS CUI [9,1])
C0032790 (UMLS CUI [9,2])
Adenomatous Polyposis Coli | Colon Carcinoma dominant inheritance
Item
no diagnosis of familial adenomatous polyposis (fap) or dominantly inherited colon cancer
boolean
C0032580 (UMLS CUI [1])
C0699790 (UMLS CUI [2,1])
C0678942 (UMLS CUI [2,2])
Patient Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Illness Serious
Item
no concurrent serious illness
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Carcinoma First line treatment Complete | Recurrent disease Evidence | follow-up Interferes with Clinical Study Follow-up
Item
history of other carcinoma allowed provided primary treatment has been completed, there is no evidence of recurrent disease, and there is no follow-up that conflicts with study follow-up
boolean
C0007097 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0277556 (UMLS CUI [2,1])
C3887511 (UMLS CUI [2,2])
C1522577 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C3274571 (UMLS CUI [3,3])
Prior Therapy
Item
prior concurrent therapy:
boolean
C1514463 (UMLS CUI [1])
disease characteristic
Item
see disease characteristics
boolean
C0599878 (UMLS CUI [1])
Rectal Carcinoma Therapeutic radiology procedure Preoperative | Rectal Carcinoma Chemoradiotherapy Preoperative | Excision Curative Complete
Item
pre-operative radiotherapy or chemoradiotherapy for rectal cancer allowed provided curative resection has been achieved
boolean
C0007113 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0445204 (UMLS CUI [1,3])
C0007113 (UMLS CUI [2,1])
C0436307 (UMLS CUI [2,2])
C0445204 (UMLS CUI [2,3])
C0728940 (UMLS CUI [3,1])
C1276305 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
Study Subject Participation Status Interferes with Clinical Study Follow-up
Item
no concurrent participation in a primary treatment clinical trial with conflicting follow-up requirements
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
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