ID

23818

Beschreibung

Metabolomics-Based Detection of Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00507598

Link

https://clinicaltrials.gov/show/NCT00507598

Stichworte

Versionen (1)
  1. 14.07.17 14.07.17 -
Hochgeladen am

14. Juli 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00507598

Englisch

Eligibility Colorectal Cancer NCT00507598

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with resectable colorectal cancer must have samples collected (serum/urine) prior to surgery and/or after surgery, but prior to starting chemotherapy.
Beschreibung

Colorectal Carcinoma Resectable | Collection Serum specimen | Urine Specimen Collection | Operative Surgical Procedures | Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C1514888
UMLS CUI [2,1]
C1516698
UMLS CUI [2,2]
C1292516
UMLS CUI [3]
C0200354
UMLS CUI [4]
C0543467
UMLS CUI [5]
C0392920
patients with metastatic colorectal cancer must have samples collected prior to initiating chemotherapy, and after chemotherapy initiation: every 3 months for up to 24 months.
Beschreibung

Colorectal cancer metastatic | Specimen Collection | Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0948380
UMLS CUI [2]
C0200345
UMLS CUI [3]
C0392920
subjects must be ≥ 18 years of age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
subjects undergoing screening colonoscopy are able to participate as healthy controls or as patients with colon polyps if colonoscopy identifies colon polyps being present (informed consent will be signed first and samples will be collected; after colonoscopy the samples will be identified as "healthy" or "polyps").
Beschreibung

Colonoscopy | Healthy Control | Colonic Polyps | Informed Consent | Specimen Collection

Datentyp

boolean

Alias
UMLS CUI [1]
C0009378
UMLS CUI [2]
C2986479
UMLS CUI [3]
C0009376
UMLS CUI [4]
C0021430
UMLS CUI [5]
C0200345
for patients who underwent biopsy or surgery for colorectal cancer, enough tissue needs to be available for testing, as appropriate per patients groups in the protocol schema.
Beschreibung

Biopsy Colorectal Carcinoma | Operative Surgical Procedures Colorectal Carcinoma | Tumor tissue sample Available Testing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0009402
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0009402
UMLS CUI [3,1]
C0475358
UMLS CUI [3,2]
C0470187
UMLS CUI [3,3]
C0039593
subjects must be able to attend follow up or treatment visits per investigator's recommendations for up to 24 months for collection of serum/urine specimens.
Beschreibung

Protocol Compliance | Collection Serum specimen | Urine Specimen Collection

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C1516698
UMLS CUI [2,2]
C1292516
UMLS CUI [3]
C0200354
female patients known to be pregnant are not eligible for this protocol.
Beschreibung

Pregnancy Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C2828389
subjects must be able to undergo an 8-hr overnight fast prior to metabolomic testing
Beschreibung

Fasting Overnight Ability | Metabolic profiling Test

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015663
UMLS CUI [1,2]
C0439583
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C1328813
UMLS CUI [2,2]
C0392366
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of an invasive cancer other than colorectal cancer is an exclusion criterion
Beschreibung

Invasive cancer | Colorectal Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2]
C0009402
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Ähnliche Modelle

Eligibility Colorectal Cancer NCT00507598

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma Resectable | Collection Serum specimen | Urine Specimen Collection | Operative Surgical Procedures | Chemotherapy
Item
patients with resectable colorectal cancer must have samples collected (serum/urine) prior to surgery and/or after surgery, but prior to starting chemotherapy.
boolean
C0009402 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
C1516698 (UMLS CUI [2,1])
C1292516 (UMLS CUI [2,2])
C0200354 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
C0392920 (UMLS CUI [5])
Colorectal cancer metastatic | Specimen Collection | Chemotherapy
Item
patients with metastatic colorectal cancer must have samples collected prior to initiating chemotherapy, and after chemotherapy initiation: every 3 months for up to 24 months.
boolean
C0948380 (UMLS CUI [1])
C0200345 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
Age
Item
subjects must be ≥ 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Colonoscopy | Healthy Control | Colonic Polyps | Informed Consent | Specimen Collection
Item
subjects undergoing screening colonoscopy are able to participate as healthy controls or as patients with colon polyps if colonoscopy identifies colon polyps being present (informed consent will be signed first and samples will be collected; after colonoscopy the samples will be identified as "healthy" or "polyps").
boolean
C0009378 (UMLS CUI [1])
C2986479 (UMLS CUI [2])
C0009376 (UMLS CUI [3])
C0021430 (UMLS CUI [4])
C0200345 (UMLS CUI [5])
Biopsy Colorectal Carcinoma | Operative Surgical Procedures Colorectal Carcinoma | Tumor tissue sample Available Testing
Item
for patients who underwent biopsy or surgery for colorectal cancer, enough tissue needs to be available for testing, as appropriate per patients groups in the protocol schema.
boolean
C0005558 (UMLS CUI [1,1])
C0009402 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0009402 (UMLS CUI [2,2])
C0475358 (UMLS CUI [3,1])
C0470187 (UMLS CUI [3,2])
C0039593 (UMLS CUI [3,3])
Protocol Compliance | Collection Serum specimen | Urine Specimen Collection
Item
subjects must be able to attend follow up or treatment visits per investigator's recommendations for up to 24 months for collection of serum/urine specimens.
boolean
C0525058 (UMLS CUI [1])
C1516698 (UMLS CUI [2,1])
C1292516 (UMLS CUI [2,2])
C0200354 (UMLS CUI [3])
Pregnancy Excluded
Item
female patients known to be pregnant are not eligible for this protocol.
boolean
C0032961 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Fasting Overnight Ability | Metabolic profiling Test
Item
subjects must be able to undergo an 8-hr overnight fast prior to metabolomic testing
boolean
C0015663 (UMLS CUI [1,1])
C0439583 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C1328813 (UMLS CUI [2,1])
C0392366 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Invasive cancer | Colorectal Carcinoma
Item
presence of an invasive cancer other than colorectal cancer is an exclusion criterion
boolean
C0677898 (UMLS CUI [1])
C0009402 (UMLS CUI [2])
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