Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000028000
Ethics application status
Approved
Date submitted
6/01/2010
Date registered
11/01/2010
Date last updated
10/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Utilization of 5HTT gene polymorphism as a prognostic indicator in cancer
Scientific title
Effect of 5HTT gene polymorphism on the progression-free survival of cancer patients
Secondary ID [1] 1251 0
STDF project 2009/225
Issuing Authority: Science and Technology Development Fund (STDF) operating under the Ministry of Higher Education and Scientific Research
Universal Trial Number (UTN)
U1111-1114-1269
Trial acronym
ICIC-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer. We are recruiting patients with a known primary cancer of the following types: lymphoma, lung, gastrointestinal tumours, genitourinary tumours, hepatocellular cancer, breast, nasopharyngeal cancers). Adjustment for cancer type in the statisticall analysis will be done by including cancer type in the regression model. 256488 0
Condition category
Condition code
Cancer 256656 256656 0 0
Other cancer types

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We are registering the first part of the research program which is an observational phase where differences in outcome between patients with at least one short allele of the 5HTT gene are compared to patients with long aleles. Patients will be observed for two years. Assessment of response rate, progression-free survival, quality of life outcomes and overall survival will be conducted at baseline, 6 months, 1 year and 2 years. A planned second stage is an interventional stage where patients with at least one short allele are randomised to an intervention arm that starts their treatment with a concurrent comprehensive psychiatric care program and a control arm that receives standard treatment (without the psychiatric intervention)
Intervention code [1] 255772 0
Not applicable
Comparator / control treatment
5HTT gene polymorphism (patients with long/long genotype compared to patients with short/short or short/long genotype)
Control group
Active

Outcomes
Primary outcome [1] 257553 0
Time to progression will be the primary endpoint, where progression is defined as one or more of the following: death attributable to cancer, appearance of new lesions, unequivocal increase in size of existing lesions, persistent elevation in levels of tumour markers. Decline in performance status or increase in tumour-related symptoms are not going to be accepted as indicators of progression unless supported by objective evidence of tumour progression obtained by radiological and/or laboratory assessment.
Timepoint [1] 257553 0
baseline, 6 months, 1 year and 2 year follow up points
Secondary outcome [1] 262795 0
objective response rate at 6 months , 1 year and 2 years measured according to Response Evaluation criteria for solid tumours (RECIST) criteria. At baseline, tumor lesions will be categorized according to RECIST criteria as follows: "measurable (lesions that can be accurately measured in at least one dimension [longest diameter to be recorded] as 20 mm with conventional techniques or as 10 mm with spiral computerized tomographic scan) or non-measurable (all other lesions, including small lesions [longest diameter <20 mm with conventional techniques or <10 mm with spiral computerized tomographic scan] and truly non-measurable lesions). Lesions considered to be truly non- measurable include the following: bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, inflammatory breast disease, lymphangitis cutis/ pulmonis, and cystic lesions." All measurements will be recorded in metric notation. Baseline assessment will be performed as close as possible to the start of treatment. Patients with non-measurable disease, or who develop non measurable or truly non-measurable lesions subsequently over the two years of follow up, will be recorded as such for the purpose of statistical analysis. For those non-measurable lesions in which response to treatment cannot be mapped to the RECIST response criteria either by complete disappearance or obvious progression, response will be recorded as non measurable for the purpose of analysis.
The same method of assessment and the same technique will be used to characterize each identified and reported lesion at baseline and during follow-up. Methods of assessment will be:
-Clinical examination
-Computerized Tomography (CT) scan
-Magnetic Resonance Imaging (MRI)
-Tumour marker level
The method of assessment used for each patient will be the method that is clinically appropriate for the patient's condition, type of cancer and tumour site(s). This is to avoid, from the ethical perspective, exposing the patient to investigational procedures that would not normally be part of their clinical follow up protocol. For the same reason, patients who are assessed at baseline with endoscopic or laparoscopic procedures will be considered ineligible unless preoperative CT/MRI evaluation is available and their clinical follow up plan includes further evaluation with CT or MRI. This is because it will be difficult, on ethical grounds, to justify the repeat endoscopy/laparoscopy at the 6 month , 1 year and 2 year follow up points.
Timepoint [1] 262795 0
Disease state is assessed at baseline. Response rate according to RECIST criteria will be assessed at the 6 months, 1 year and 2 years follow up points.
Secondary outcome [2] 262796 0
Physical, emotional and functional staustus ; and overall Quality of Life using the Functional Assessment of cancer therapy genral module (FACT-G)
Timepoint [2] 262796 0
baseline, 6 months, 1 year, 2 years
Secondary outcome [3] 262797 0
Hospital Anxiety and Depression Scale (HADS)
Timepoint [3] 262797 0
baseline, 6 month, 1 year and 2 years

Eligibility
Key inclusion criteria
-Over 16 years of age
-Have a known primary cancer
-Able and willing to give consent
-Life expectancy more than 6 months

For study 2, an additional criterion will be added: the possession of at least one short allele of the 5HTT gene.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients are considered ineligible if they have overt psychopathology or mental impairment at enrollment into the study, or if they are enrolled in other behavioural or psychosocial studies

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 2388 0
Egypt
State/province [1] 2388 0

Funding & Sponsors
Funding source category [1] 256258 0
Other
Name [1] 256258 0
Egyptian Science and Technology Development Fund
Country [1] 256258 0
Egypt
Primary sponsor type
University
Name
University of Alexandria
Address
University Administration Building
Elchatby
Alexandria
Country
Egypt
Secondary sponsor category [1] 251588 0
None
Name [1] 251588 0
Address [1] 251588 0
Country [1] 251588 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258350 0
Local ethics committee of faculty of medicine
Ethics committee address [1] 258350 0
Ethics committee country [1] 258350 0
Egypt
Date submitted for ethics approval [1] 258350 0
01/10/2008
Approval date [1] 258350 0
15/10/2008
Ethics approval number [1] 258350 0
no number. we have approval letter

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

Contacts
Principal investigator
Name 30671 0
Address 30671 0
Country 30671 0
Phone 30671 0
Fax 30671 0
Email 30671 0
Contact person for public queries
Name 13918 0
Dr.Khaled Elsaadany
Address 13918 0
Grants office
Department of Dairy Technology
Faculty of Agriculture
University of Alexandria
Elchatby
Alexandria
Country 13918 0
Egypt
Phone 13918 0
+2 10 1717303
Fax 13918 0
+2 03 5908338
Email 13918 0
[email protected]
Contact person for scientific queries
Name 4846 0
Dr.Noha Awad
Address 4846 0
Epidemiology department
High Institute of Public Health
165 Elhorreya Road
Hadara
Alexandria
Egypt
Country 4846 0
Egypt
Phone 4846 0
+2 11 2287247
Fax 4846 0
+2 03 428846
Email 4846 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.