Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000193572
Ethics application status
Approved
Date submitted
6/02/2015
Date registered
27/02/2015
Date last updated
11/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Blood test for diagnosis of cancer cachexia
Scientific title
Comparison of Il-6 and CRP levels in patients with non-small cell Lung cancer, ovarian cancer, colon cancer or cervical cancer with or without cachexia
Secondary ID [1] 286123 0
NIL
Universal Trial Number (UTN)
U1111-1166-7826
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer Cachexia 294125 0
Cancer , Lung-Non small cell 294127 0
Cancer, Ovarian and primary peritoneal 294177 0
Cancer, Bowel-Back passage(rectum) or large bowel (colon). 294179 0
Cancer, Cervical (cervix). 294180 0
Condition category
Condition code
Cancer 294442 294442 0 0
Lung - Non small cell
Cancer 294675 294675 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We will take blood samples from both the cases and controls during their check-up. We will use ELISA Kits to measure IL-6 and CRP in each case and controls. Then we will get the results from both the cases and controls and compare it. The blood sample will be taken once only.
Intervention code [1] 291121 0
Not applicable
Comparator / control treatment
Control group will be patients with the same type of cancer but do not have cachexia.
Control group
Active

Outcomes
Primary outcome [1] 294236 0
The 1st primary outcome of the study is to compare the level of IL-6 in patients with cancer cachexia and patients with the same cancer type that do not have cachexia . The outcome will be assed by serum analysis using ELISA (test).
Timepoint [1] 294236 0
We aim to detect a minimum of 3 mmol/ L between the cases and the controls at one month after the recruitment.
Primary outcome [2] 294286 0
The 2nd primary outcome is to compare the level of CRP in the cases with the level of CRP in the controls by serum analysis using ELISA (test).
Timepoint [2] 294286 0
At one month after the recruitment.
Secondary outcome [1] 312943 0
To determine if IL-6 can be used as a predictive biomarker for the likely onset of cancer cachexia by analysis of the serum using ELISA (test).
Timepoint [1] 312943 0
At 3 months after the result of the analysis.
Secondary outcome [2] 312944 0
To determine if CRP can be used as a predictive biomarker for the likely onset of cancer cachexia by analysis of serum using ELISA (test).
Timepoint [2] 312944 0
At 3 months after the analysis.

Eligibility
Key inclusion criteria
Cases, from cachexia clinic at the national Cancer Institute, Cairo University who have cancer cachexia related to underlying non-small cell lung cancer, colon cancer, ovarian cancer or cervical cancer. Controls patients from the oncology clinic who have the same type of cancer but who do not have cachexia. The primary diagnosis of the controls should be less than or within 6 months. All the patients should have a biopsy proven the diagnosis of cancer. Non of the patients will have an inflammatory diseases other than cancer or cancer cachexia.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The primary diagnosis of the controls less than or within 6 months from the diagnosis.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/02/2015
Actual
2/02/2015
Date of last participant enrolment
Anticipated
Actual
25/02/2016
Date of last data collection
Anticipated
Actual
15/08/2016
Sample size
Target
321
Accrual to date
Final
357
Recruitment outside Australia
Country [1] 6633 0
Egypt
State/province [1] 6633 0
Cairo

Funding & Sponsors
Funding source category [1] 290701 0
University
Name [1] 290701 0
National Cancer Institute
Country [1] 290701 0
Egypt
Primary sponsor type
University
Name
National Cancer Institute
Address
National Cancer Institute
Fom El Khalid, Cairo 11796, Egypt
Country
Egypt
Secondary sponsor category [1] 289392 0
None
Name [1] 289392 0
None
Address [1] 289392 0
None
Country [1] 289392 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294361 0
Institutional Review Board Decision
Ethics committee address [1] 294361 0
National Cancer Institute, Cairo University, Egypt
Ethics committee country [1] 294361 0
Egypt
Date submitted for ethics approval [1] 294361 0
20/11/2014
Approval date [1] 294361 0
25/11/2014
Ethics approval number [1] 294361 0
201516010.7
Ethics committee name [2] 294362 0
National cancer institute
Ethics committee address [2] 294362 0
National Cancer institute, Cairo University , Egypt, Fom El Khalig, Cairo 11796, Egypt
Ethics committee country [2] 294362 0
Date submitted for ethics approval [2] 294362 0
Approval date [2] 294362 0
25/11/2014
Ethics approval number [2] 294362 0
FWA No FWA00007284, IRB No IRB00004025, MD2010014011.3

Summary
Brief summary
Case Control study conducted at the National Cancer Institute, Cairo University, Egypt. The de-identified data was then used by Deakin University for secondary analysis to determine if IL-6 and or CRP could be used as a predictive biomarker for the likely onset of cachexia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54726 0
Prof Wafa Taha
Address 54726 0
National Cancer Institute
Fom El Khalig ,Cairo 11796, Egypt
Country 54726 0
Egypt
Phone 54726 0
+201222168097
Fax 54726 0
Email 54726 0
[email protected]
Contact person for public queries
Name 54727 0
Dr Prof Wafa Taha
Address 54727 0
National Cancer Institute Fom El Khalid Cairo 11796 Cairo, Egypt
Country 54727 0
Egypt
Phone 54727 0
+201222168097
Fax 54727 0
Email 54727 0
[email protected]
Contact person for scientific queries
Name 54728 0
Prof Wafa Taha
Address 54728 0
National Cancer Institute
Fom El Khalig, Cairo 11796, Egypt
Country 54728 0
Egypt
Phone 54728 0
+201222168097
Fax 54728 0
Email 54728 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.