Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000849695
Ethics application status
Approved
Date submitted
7/07/2014
Date registered
8/08/2014
Date last updated
8/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Diagnostic and Prognostic Significance of Serum "Neutrophil Gelatinase-Associated Lipocalin" in Patients with Colorectal Cancer
Scientific title
Diagnostic and Prognostic Significance of Serum "Neutrophil Gelatinase-Associated Lipocalin" in Patients with Colorectal Cancer
Secondary ID [1] 283718 0
Nil
Universal Trial Number (UTN)
U1111-1151-1580
Trial acronym
CRC-NGAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
colon cancer 290683 0
Condition category
Condition code
Cancer 291048 291048 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Colon cancer screening;
Studies on tissue samples have shown that NGAL expression increases in CRCs and inflammatory bowel diseases. This study is planned to investigate the usability of serum NGAL level as a diagnostic and/or prognostic biomarker, in patients with colorectal cancer. NGAL level was determined through serum samples. Blood was taken from each patient only once, before polypectomy (for the polip group) or surgery (for the cancer group).
Intervention code [1] 288409 0
Early detection / Screening
Intervention code [2] 288410 0
Diagnosis / Prognosis
Comparator / control treatment
Standard treatment for colorectal cancer patients (Curative resection). Control group consist of healty individuals, so any treatment didn't aplly to them. Only blood samples were taken.
Control group
Active

Outcomes
Primary outcome [1] 291039 0
Diagnostic role of serum NGAL levels on colorectal cancer patients assessed with using Human NGAL/Lipocalin-2 ELISA kit. All colorectal cancer patients serum NGAL levels determined and compared with the other groups (benign colon polyps and healthy individual).
Timepoint [1] 291039 0
12 months after reciept of all blood samples.
Secondary outcome [1] 305875 0
Prognostic role of serum NGAL levels on colorectal cancer patients assessed with using Human NGAL/Lipocalin-2 ELISA kit. NGAL levels statistically evaluated according to the tumor diameter and amount of metastatic lymph nodes in patients with colorectal cancer.
Timepoint [1] 305875 0
12 months after reciept of all samples

Eligibility
Key inclusion criteria
Patients with colorectal carsinoma
Patients with colorectal polyps without carcinoma
Control group (patients whose colonoscopy examinations revealed no pathology named as control group)
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active infection
Renal failure
Other organs cancer
Detection of less than 12 lymph nodes
Patients treated with neoadjuvant chemotherapy
Blood samples with hemolysis

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2011
Actual
12/09/2011
Date of last participant enrolment
Anticipated
Actual
6/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 6199 0
Turkey
State/province [1] 6199 0

Funding & Sponsors
Funding source category [1] 289557 0
Hospital
Name [1] 289557 0
TCSB Goztepe Education and Research Hospital
Country [1] 289557 0
Turkey
Primary sponsor type
Hospital
Name
Goztepe Education and Research Hospital
Address
Goztepe Education and Research Hospital
Doktor Erkin Street, Kadikoy, Istanbul, Turkey
Postcode:34722
Country
Turkey
Secondary sponsor category [1] 288238 0
None
Name [1] 288238 0
Address [1] 288238 0
Country [1] 288238 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291295 0
TCSB Goztepe Education and Research Hospital Ethics Committee
Ethics committee address [1] 291295 0
Ethics committee country [1] 291295 0
Turkey
Date submitted for ethics approval [1] 291295 0
Approval date [1] 291295 0
03/01/2011
Ethics approval number [1] 291295 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44806 0
Dr Ibrahim Ali Ozemir
Address 44806 0
Goztepe Education and Research Hospital
Department of General Surgery,
Doktor Erkin Street, Kadikoy, Istanbul, Turkey
Postcode:34722
Country 44806 0
Turkey
Phone 44806 0
+905058032125
Fax 44806 0
Email 44806 0
[email protected]
Contact person for public queries
Name 44807 0
Ibrahim Ali Ozemir
Address 44807 0
Goztepe Education and Research Hospital
Department of General Surgery,
Doktor Erkin Street, Kadikoy, Istanbul, Turkey
Postcode:34722
Country 44807 0
Turkey
Phone 44807 0
+905058032125
Fax 44807 0
Email 44807 0
[email protected]
Contact person for scientific queries
Name 44808 0
Ibrahim Ali Ozemir
Address 44808 0
Goztepe Education and Research Hospital
Department of General Surgery,
Doktor Erkin Street, Kadikoy, Istanbul, Turkey
Postcode:34722
Country 44808 0
Turkey
Phone 44808 0
+905058032125
Fax 44808 0
Email 44808 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.