Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000839202
Ethics application status
Approved
Date submitted
24/09/2009
Date registered
28/09/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Identification of Predictive and Prognostic Factors in Malignant Pleural Mesothelioma
Scientific title
Identification of Predictive and Prognostic Factors in Malignant Pleural Mesothelioma
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant pleural mesothelioma 251918 0
Condition category
Condition code
Cancer 252095 252095 0 0
Lung - Mesothelioma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
For the retrospective part, the following variables will be observed:
- immunohistochemical (IHC) staining of the archival tumour tissues
- micro Ribonucleic acid (miRNA) expression of the tumour tissues

For the prospective part, the following variables will be observed:
- clinical/demographic details at baseline only
- IHC staining of the tumour at baseline only
- miRNA of the tumour at baseline only
- Quality of life (QoL) data at baseline then at regular intervals depending on therapy prescribed by treating physician
- blood tests including full blood counts, electrolytes, renal function and liver function at baseline then at regular intervals depending on therapy prescribed by treating physician
- inflammatory markers + cytokines at baseline then at regular intervals depending on therapy prescribed by treating physician
- plasma proteomic at baseline then at regular intervals depending on therapy prescribed by treating physician
- nutritional assessment at baseline then at regular intervals depending on therapy prescribed by treating physician
- Computed Tomography (CT) scan at baseline, after 4 cycles of chemotherapy, at completion of chemotherapy and then at physician's discretion.
Intervention code [1] 241337 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 252977 0
Overall survival assessed by data registry
Timepoint [1] 252977 0
3 years following commencement of the study
Secondary outcome [1] 257734 0
Progression Free Survival as assessed by symptoms and/or imaging modality such as CT scans on follow up
Timepoint [1] 257734 0
3 years after commencement of the study
Secondary outcome [2] 257735 0
Chemotherapy Response Rate as assessed by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria
Timepoint [2] 257735 0
after 4 cycles of chemotherapy and at completion of chemotherapy
Secondary outcome [3] 257736 0
Development of haematological and non-haematological chemotherapy toxicity as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Timepoint [3] 257736 0
after each cycles of chemotherapy

Eligibility
Key inclusion criteria
- Patients with a diagnosis of malignant pleural mesothelioma
- Age over 18 years.
- Ability to comply with the planned procedures and provide written evidence of informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with other malignancies who are undergoing active chemotherapy treatment.
- Patients with insufficient English where the QoL questionnaires are not available in their own language will be excluded only from the QoL component of the study only but can still participate in the main study.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2131 0
2139

Funding & Sponsors
Funding source category [1] 243790 0
Charities/Societies/Foundations
Name [1] 243790 0
Asbestos Diseases Research Institute
Country [1] 243790 0
Australia
Primary sponsor type
Individual
Name
Stephen Clarke
Address
Department of Medical Oncology
Concord Hospital
Hospital Rd
Concord
NSW 2139
Country
Australia
Secondary sponsor category [1] 237144 0
Individual
Name [1] 237144 0
Janette Vardy
Address [1] 237144 0
Department of Medical Oncology
Concord Hospital
Hospital Rd
Concord
NSW 2139
Country [1] 237144 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243917 0
Sydney South West Area Health Services (SSWAHS) Human Research Ethics Committee - Conocord Repatriation General Hospital (CRGH)
Ethics committee address [1] 243917 0
Concord Repatriation General Hospital
Hospital Rd
Concord
NSW 2139
Ethics committee country [1] 243917 0
Australia
Date submitted for ethics approval [1] 243917 0
Approval date [1] 243917 0
20/07/2009
Ethics approval number [1] 243917 0
HREC/09/CRGH/90
Ethics committee name [2] 243918 0
SSWAHS - Royal Prince Alfred Hospital (RPAH) Zone
Ethics committee address [2] 243918 0
Research Development Office
Level 3, Building 92
Royal Prince Alfred Hospital
Missenden Rd
Camperdown
NSW 2050
Ethics committee country [2] 243918 0
Australia
Date submitted for ethics approval [2] 243918 0
Approval date [2] 243918 0
17/09/2009
Ethics approval number [2] 243918 0
SSA/09/RPAH/391

Summary
Brief summary
This study will attempt to identify potential clinical, histopathological and other novel predictors of survival outcomes in patients with malignant mesothelioma.

Who is it for?
You can join this study if you have a newly diagnosed malignant mesothelioma affecting your lung lining (pleura).

Trial details:
Participants with malignant pleural mesothelioma in all stages of disease will be recruited. Participants will be treated with the current standard medical therapy by the treating physician without study specific intervention. Participants will be consented for collection of their tumour tissue, blood samples and answering some questionnaires at baseline and subsequent follow ups.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 30328 0
Address 30328 0
Country 30328 0
Phone 30328 0
Fax 30328 0
Email 30328 0
Contact person for public queries
Name 13575 0
Steven Kao
Address 13575 0
Department of Medical Oncology
Concord Hospital
Hospital Rd
Concord
NSW 2139
Country 13575 0
Australia
Phone 13575 0
+61297676675
Fax 13575 0
+61297675764
Email 13575 0
[email protected]
Contact person for scientific queries
Name 4503 0
Steven Kao
Address 4503 0
Department of Medical Oncology
Concord Hospital
Hospital Rd
Concord
NSW 2139
Country 4503 0
Australia
Phone 4503 0
+61297676675
Fax 4503 0
+61297675764
Email 4503 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.