ID

28288

Description

Study of Biomarkers in Blood & Tissue Samples From Patients With Colorectal Cancer or Polyps & Patients Without Polyps; ODM derived from: https://clinicaltrials.gov/show/NCT00898378

Link

https://clinicaltrials.gov/show/NCT00898378

Keywords

Versions (1)
  1. 1/2/18 1/2/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 2, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00898378

English

Eligibility Colorectal Cancer NCT00898378

1 forms  
Criteria
Description

Criteria

meets 1 of the following criteria:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
diagnosis of one of the following:
Description

Diagnosis

Data type

boolean

Alias
UMLS CUI [1]
C0011900
stage i or ii colorectal cancer (crc)*
Description

Colorectal Carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C3258246
planning to undergo surgery only
Description

Operative Surgical Procedures Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1301732
stage iii crc*
Description

Colorectal Carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C3258246
planning to undergo surgery followed by adjuvant chemotherapy with or without neoadjuvant chemoradiotherapy
Description

Operative Surgical Procedures Planned | Chemotherapy, Adjuvant | Chemotherapy Neoadjuvant

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1301732
UMLS CUI [2]
C0085533
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0600558
stage iv crc
Description

Colorectal Carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C3258246
planning to undergo chemotherapy and biologic therapy (bevacizumab, cetuximab, or panitumumab)
Description

Chemotherapy Planned | Biological treatment Planned | bevacizumab | cetuximab | panitumumab

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1531518
UMLS CUI [2,2]
C1301732
UMLS CUI [3]
C0796392
UMLS CUI [4]
C0995188
UMLS CUI [5]
C0879427
colorectal adenomatous polyps
Description

Adenomatous Polyps Colorectal

Data type

boolean

Alias
UMLS CUI [1,1]
C0206677
UMLS CUI [1,2]
C0555952
planning to undergo colonoscopy
Description

Colonoscopy Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0009378
UMLS CUI [1,2]
C1301732
healthy volunteer
Description

Healthy Volunteer

Data type

boolean

Alias
UMLS CUI [1]
C1708335
planning to undergo colonoscopy note: *patients with previously resected stage ii or iii crc are eligible provided they undergo blood sample collection prior to starting chemotherapy
Description

Colonoscopy Planned | Excision Colorectal Carcinoma TNM clinical staging | Collection of blood specimen | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009378
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0728940
UMLS CUI [2,2]
C0009402
UMLS CUI [2,3]
C3258246
UMLS CUI [3]
C0005834
UMLS CUI [4]
C0392920
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
not pregnant
Description

Exclusion | Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C0032961
able to undergo an 8-hour overnight fast prior to metabolomic testing
Description

Ability Overnight Fasting | Metabolome Testing

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0439583
UMLS CUI [1,3]
C0015663
UMLS CUI [2,1]
C2350399
UMLS CUI [2,2]
C0392366
able to attend follow-up or treatment visits for up to 24 months for collection of blood samples
Description

Patient Visit Collection of blood specimen

Data type

boolean

Alias
UMLS CUI [1,1]
C1512346
UMLS CUI [1,2]
C0005834
no prior or concurrent invasive cancer other than crc (for patients with crc)
Description

Exclusion | Invasive cancer | Exception Colorectal Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C0677898
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0009402
no prior invasive cancer and no first-degree relative with a known history of crc (for healthy volunteers and patients with colorectal polyps)
Description

Exclusion Criteria | Invasive cancer | Colorectal Carcinoma First Degree Relative

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0677898
UMLS CUI [3,1]
C0009402
UMLS CUI [3,2]
C1517194
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Description

ID.20

Data type

boolean

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Similar models

Eligibility Colorectal Cancer NCT00898378

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Criteria Fulfill
Item
meets 1 of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Diagnosis
Item
diagnosis of one of the following:
boolean
C0011900 (UMLS CUI [1])
Colorectal Carcinoma TNM clinical staging
Item
stage i or ii colorectal cancer (crc)*
boolean
C0009402 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Operative Surgical Procedures Planned
Item
planning to undergo surgery only
boolean
C0543467 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Colorectal Carcinoma TNM clinical staging
Item
stage iii crc*
boolean
C0009402 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Operative Surgical Procedures Planned | Chemotherapy, Adjuvant | Chemotherapy Neoadjuvant
Item
planning to undergo surgery followed by adjuvant chemotherapy with or without neoadjuvant chemoradiotherapy
boolean
C0543467 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0085533 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
Colorectal Carcinoma TNM clinical staging
Item
stage iv crc
boolean
C0009402 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Chemotherapy Planned | Biological treatment Planned | bevacizumab | cetuximab | panitumumab
Item
planning to undergo chemotherapy and biologic therapy (bevacizumab, cetuximab, or panitumumab)
boolean
C0392920 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1531518 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0796392 (UMLS CUI [3])
C0995188 (UMLS CUI [4])
C0879427 (UMLS CUI [5])
Adenomatous Polyps Colorectal
Item
colorectal adenomatous polyps
boolean
C0206677 (UMLS CUI [1,1])
C0555952 (UMLS CUI [1,2])
Colonoscopy Planned
Item
planning to undergo colonoscopy
boolean
C0009378 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Healthy Volunteer
Item
healthy volunteer
boolean
C1708335 (UMLS CUI [1])
Colonoscopy Planned | Excision Colorectal Carcinoma TNM clinical staging | Collection of blood specimen | Chemotherapy
Item
planning to undergo colonoscopy note: *patients with previously resected stage ii or iii crc are eligible provided they undergo blood sample collection prior to starting chemotherapy
boolean
C0009378 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0728940 (UMLS CUI [2,1])
C0009402 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
C0005834 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Exclusion | Pregnancy
Item
not pregnant
boolean
C2828389 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Ability Overnight Fasting | Metabolome Testing
Item
able to undergo an 8-hour overnight fast prior to metabolomic testing
boolean
C0085732 (UMLS CUI [1,1])
C0439583 (UMLS CUI [1,2])
C0015663 (UMLS CUI [1,3])
C2350399 (UMLS CUI [2,1])
C0392366 (UMLS CUI [2,2])
Patient Visit Collection of blood specimen
Item
able to attend follow-up or treatment visits for up to 24 months for collection of blood samples
boolean
C1512346 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Exclusion | Invasive cancer | Exception Colorectal Carcinoma
Item
no prior or concurrent invasive cancer other than crc (for patients with crc)
boolean
C2828389 (UMLS CUI [1])
C0677898 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0009402 (UMLS CUI [3,2])
Exclusion Criteria | Invasive cancer | Colorectal Carcinoma First Degree Relative
Item
no prior invasive cancer and no first-degree relative with a known history of crc (for healthy volunteers and patients with colorectal polyps)
boolean
C0680251 (UMLS CUI [1])
C0677898 (UMLS CUI [2])
C0009402 (UMLS CUI [3,1])
C1517194 (UMLS CUI [3,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.20
Item
see disease characteristics
boolean
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