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Trial registered on ANZCTR


Registration number
ACTRN12618000712202
Ethics application status
Approved
Date submitted
26/03/2018
Date registered
1/05/2018
Date last updated
2/04/2019
Date data sharing statement initially provided
2/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Embedding Research (and evidence) in Cancer Healthcare (EnRICH)
Scientific title
Embedding Research (and evidence) in Cancer Healthcare (EnRICH)
Secondary ID [1] 293455 0
None
Universal Trial Number (UTN)
Trial acronym
EnRICH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 305634 0
Condition category
Condition code
Cancer 304854 304854 0 0
Lung - Non small cell
Cancer 304855 304855 0 0
Lung - Small cell

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
60
Target follow-up type
Months
Description of intervention(s) / exposure
The aim of this program is to assemble a patient cohort to describe the natural history of and patterns of care for lung cancer. Questionnaires and blood collection will be performed once at three, six, and twelve months, and annually thereafter. The duration of the program is at least five years. Questionnaires will take approximately 10-15min to complete. Tumour tissue taken at biopsy or surgical resection will be archived for sub-studies.
Intervention code [1] 300431 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304905 0
Patient timeline from symptom presentation to diagnosis as assessed by study-specific questionnaire and data linkage to medical records.
Timepoint [1] 304905 0
Baseline at enrolment, 3 months, 6 months, 12 months and annually thereafter up to 5 years.
Secondary outcome [1] 343580 0
Exploratory genetic screening using blood and tissue samples.
Timepoint [1] 343580 0
Baseline at enrolment, 3 months, 6 months, 12 months and annually thereafter up to 5 years. Tissue samples will only be obtained at biopsy or resection.
Secondary outcome [2] 345053 0
Exploratory biomarker screening using tissue and blood samples.
Timepoint [2] 345053 0
Baseline, 3 month, 6 month, 12 month, and annually thereafter to the completion of 5 years. Tissue samples will only be obtained at biopsy or resection.

Eligibility
Key inclusion criteria
All patients with lung cancer presenting to defined clinical sites for diagnosis or treatment, including:

Patients with a new diagnosis of primary lung cancer (any histological type, any pathological/clinical stage including metastatic) undergoing primary treatment (including observation and clinical advice that no anti-cancer therapy is necessary/appropriate); curative or palliative.

Patients with first progressive disease, local recurrence or new metastasis after completing previous curative treatment for non-metastatic disease at the time of initial diagnosis.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a lung tumour which is a metastasis from a non-lung primary site.

Patients diagnosed with mesothelioma.

Patients with cognitive or intellectual impairment or significant mental illness who are unable to give informed consent.

Patients presenting for a second specialist opinion ONLY

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Characteristics of the Cohort will be described along with the tumour and treatment patterns. Recurrence free and overall survival will be estimated for key subgroups of patients using the Kaplan-Meier method and compared using log-rank tests where appropriate.

The sample size of 1000 patients will be sufficient to estimate proportions with 95% confidence intervals with width at most +/- 3.1% for the complete cohort, +/6.9% for 20% of the cohort (e.g. small cell carcinomas, KRAS2 mutation) and +/-9.8% for 10% of the cohort (e.g. large cell carcinomas).

Analysis of patient outcomes and guideline indicators will describe variability across disease, institutional and patient characteristics. Changes in outcomes and indicators over time will be estimated using longitudinal models with an emphasis on describing trends.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10110 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 10111 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [3] 10112 0
Concord Repatriation Hospital - Concord
Recruitment hospital [4] 10113 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [5] 10114 0
Bathurst Base Hospital - Bathurst
Recruitment hospital [6] 10115 0
Orange Health Service - Orange
Recruitment hospital [7] 10116 0
Dubbo Base Hospital - Dubbo
Recruitment hospital [8] 10117 0
Coffs Harbour Base Hospital - Coffs Harbour
Recruitment postcode(s) [1] 21645 0
2050 - Camperdown
Recruitment postcode(s) [2] 21646 0
2139 - Concord
Recruitment postcode(s) [3] 21647 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 21648 0
2795 - Bathurst
Recruitment postcode(s) [5] 21649 0
2800 - Orange
Recruitment postcode(s) [6] 21650 0
2830 - Dubbo
Recruitment postcode(s) [7] 21651 0
2450 - Coffs Harbour

Funding & Sponsors
Funding source category [1] 299312 0
Government body
Name [1] 299312 0
Cancer Institute NSW
Address [1] 299312 0
8 Central Ave
Eveleigh
NSW 2015
Country [1] 299312 0
Australia
Funding source category [2] 299313 0
Hospital
Name [2] 299313 0
Sydney Local Health District
Address [2] 299313 0
Level 11, KGV Building
Missenden Road
CAMPERDOWN NSW 2050
Country [2] 299313 0
Australia
Primary sponsor type
University
Name
Sydney Catalyst Translational Cancer Research Centre, University of Sydney
Address
NHMRC Clinical Trial Centre
Level 6, Chris O'Brien Lifehouse
119-143 Missenden Road
NSW 2050
Country
Australia
Secondary sponsor category [1] 298301 0
None
Name [1] 298301 0
Address [1] 298301 0
Country [1] 298301 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299102 0
SLHD (RPAH Zone) Human Research Ethics Committee (HREC)
Ethics committee address [1] 299102 0
Research Ethics and Governance Office
Royal Prince Alfred Hospital
Camperdown NSW 2050
Ethics committee country [1] 299102 0
Australia
Date submitted for ethics approval [1] 299102 0
30/11/2016
Approval date [1] 299102 0
23/12/2016
Ethics approval number [1] 299102 0
X16-0447

Summary
Brief summary
Short title EnRICH
Protocol number and date X16-0447 dated 29/03/2017

This study aims to assemble a patient cohort to describe the natural history of and patterns of care for lung cancer; identify current gaps in evidence and practice for clinical quality improvement.

Who is it for?
You may be eligible for this study if you are aged 18 or over and have a diagnosis of lung cancer and are attending a defined clinical site for diagnosis or treatment.

Study details
All participants will provide demographic information, and their medical records will be used to build a profile of the participant’s cancer, including clinical and outcome information. Participants will also provide around 3 blood samples for research taken at the time of routine collection (e.g. prior to commencement of treatment, post-treatment). Biopsied tumour samples will be used to screen for biomarkers and molecular signals of disease.

This research will assemble a patient cohort for identifying current gaps in evidence and practice, creating a platform for researchers across the translational research spectrum to develop and initiate studies to address these gaps.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79294 0
Prof John Simes
Address 79294 0
Level 6, Chris O'Brien Lifehouse
119-143 Missenden Road
Camperdown 2050 NSW
Country 79294 0
Australia
Phone 79294 0
+61 2 9562 5001
Fax 79294 0
Email 79294 0
John@ctc.usyd.edu.au
Contact person for public queries
Name 79295 0
Dr Bea Brown
Address 79295 0
Level 6, Chris O'Brien Lifehouse
119-143 Missenden Road
Camperdown 2050 NSW
Country 79295 0
Australia
Phone 79295 0
+61 2 8036 5248
Fax 79295 0
Email 79295 0
bea.brown@ctc.usyd.edu.au
Contact person for scientific queries
Name 79296 0
Dr Bea Brown
Address 79296 0
Level 6, Chris O'Brien Lifehouse
119-143 Missenden Road
Camperdown 2050 NSW
Country 79296 0
Australia
Phone 79296 0
+61 2 8036 5248
Fax 79296 0
Email 79296 0
bea.brown@ctc.usyd.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Summary results
No Results