Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000027617
Ethics application status
Approved
Date submitted
19/12/2013
Date registered
9/01/2014
Date last updated
9/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Identification of biomarkers in patients with malignant pleural mesothelioma undergoing chemotherapy
Scientific title
Identification of Predictive and Prognostic Factors in Malignant Pleural Mesothelioma Patients Undergoing Chemotherapy
Secondary ID [1] 283794 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mesothelioma 290786 0
Condition category
Condition code
Cancer 291152 291152 0 0
Lung - Mesothelioma

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Years
Description of intervention(s) / exposure
Standard chemotherapy or investigational agents used to treat patients with malignant pleural mesothelioma.
Malignant pleural mesothelioma is an aggressive cancer arising from the mesothelium of the pleural cavity, that is typically caused by previous inhalation of asbestos fibres.
Typical standard chemotherapy may include a combination of a platinum compound with pemetrexed or gemcitabine. Other chemotherapy agents that could be used include single agent vinorelbine and gemcitabine.
Patients who are enrolled in other clinical trials using an investigational agent may be eligible for this observational study also.
Duration of observation is from commencement of chemotherapy to death.
Intervention code [1] 288493 0
Not applicable
Comparator / control treatment
no control treatment/arm
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291139 0
Overall Survival
Timepoint [1] 291139 0
time of patient death as assessed by routine clinical follow up in the treatment centre.
If patients are lost to follow up, NSW Cancer Registry may be contacted.
Secondary outcome [1] 306102 0
Progression Free Survival
Timepoint [1] 306102 0
Time of disease progression with chemotherapy as assessed by symptoms and/or imaging modality such as CT scans on routine clinical follow up as per the treating physician. This may typically involve restaging CT scan every 2 to 3 cycles of chemotherapy while on treatment followed by restaging scan every 2-3 months after completion of chemotherapy. This is at the discretion of the treating physician.
Secondary outcome [2] 306103 0
Response rate per modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria
Timepoint [2] 306103 0
end of chemotherapy
Secondary outcome [3] 306104 0
Haematological and non-haematological chemotherapy toxicity as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
Timepoint [3] 306104 0
At the end of each cycle of chemotherapy during treatment

Eligibility
Key inclusion criteria
- pathological diagnosis of malignant pleural mesothelioma
- about to commence on chemotherapy of choice by the treating physician - including first line, second line or experimental regimens
- ability to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other malignancies requiring active treatments

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2013
Actual
23/02/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288467 0
Charities/Societies/Foundations
Name [1] 288467 0
Asbestos Diseases Research Institute
Country [1] 288467 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Asbestos Diseases Research Institute
Address
Gate 3, Hospital Road
Concord
NSW 2139
Australia
Country
Australia
Secondary sponsor category [1] 287169 0
Other Collaborative groups
Name [1] 287169 0
Pharmacogenomic Research for Individualised Medicine (PRIMe) Group
Address [1] 287169 0
Level 6
The Kinghorn Cancer Centre
370 Victoria St
DARLINGHURST NSW 2010
AUSTRALIA
Country [1] 287169 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290335 0
Sydney Local health District (SLHD) - Concord Repatriation General Hospital (CRGH)
Ethics committee address [1] 290335 0
Building 75
CRGH
Hospital Road
Concord
NSW 2139
Ethics committee country [1] 290335 0
Australia
Date submitted for ethics approval [1] 290335 0
Approval date [1] 290335 0
10/10/2012
Ethics approval number [1] 290335 0
CH62/6/2012-127 (HREC/12/CRGH/164)

Summary
Brief summary
The study will investigate how to improve identification of patients with malignant pleural mesothelioma who will derive benefit from treatment with chemotherapy and/or investigational agents, and also identify any potential factors that may predict overall outcome of the patients including survival (prognostic factors) so that individualised therapy is possible for patients with malignant pleural mesotheliom.

Who is it for?
You may be eligible to join this study if you are aged over 18 years, have a pathological diagnosis of malignant pleural mesothelioma, and about to commence on chemotherapy of choice by the treating physician including first line, second line or experimental regimens.

Trial details:
Participants with malignant pleural mesothelioma in all stages of disease will be recruited.
Participants will be treated with the current chemotherapy of choice by the treating physician, including first line, second line or experimental regimens. There is no 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
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45078 0
Dr Steven Kao
Address 45078 0
chris O'Brien Lifehouse
PO Box M33
Missenden Road
NSW 2050
Country 45078 0
Australia
Phone 45078 0
+61285140594
Fax 45078 0
Email 45078 0
[email protected]
Contact person for public queries
Name 45079 0
Ms Rebecca Hyland
Address 45079 0
Asbestos Diseases Research Institute
Gate 3, Hospital Road
Concord
NSW 2139
Country 45079 0
Australia
Phone 45079 0
+61297679800
Fax 45079 0
Email 45079 0
[email protected]
Contact person for scientific queries
Name 45080 0
Dr steven kao
Address 45080 0
Chris O'Brien Lifehouse
PO Box M33
Missenden Road
NSW 2050
Country 45080 0
Australia
Phone 45080 0
+61285140594
Fax 45080 0
Email 45080 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.