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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05218824




Registration number
NCT05218824
Ethics application status
Date submitted
8/12/2021
Date registered
1/02/2022

Titles & IDs
Public title
Collection of Head Images During Radiotherapy
Scientific title
Collection of Head Images During Radiotherapy (CHIRP)
Secondary ID [1] 0 0
IX-2021-P0-CHIRP
Universal Trial Number (UTN)
Trial acronym
CHIRP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Neoplasms 0 0
Radiation Therapy Complication 0 0
Condition category
Condition code
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Translational head motion between different radiation therapy treatment sessions
Timepoint [1] 0 0
8 weeks
Primary outcome [2] 0 0
Rotational head motion between different radiation therapy treatment sessions
Timepoint [2] 0 0
8 weeks
Primary outcome [3] 0 0
Head deformation between different radiation therapy treatment sessions
Timepoint [3] 0 0
8 weeks
Secondary outcome [1] 0 0
Difference in structural similarity (SSIM) indexes between artificial and real X-rays
Timepoint [1] 0 0
8 weeks
Secondary outcome [2] 0 0
Difference in mean absolute error between artificial and real X-rays
Timepoint [2] 0 0
8 weeks

Eligibility
Key inclusion criteria
* A diagnosis of head and neck cancer (any stage)
* Age 18 years or greater
* Receiving radiation therapy to the head and neck with a thermoplastic immobilisation mask
* An ECOG score in the range of 0 to 2
* Any other prior or concurrent therapy allowed
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* People with cognitive impairment which would preclude them from providing informed consent
* People who are unable to speak and read English and for whom obtaining consent would be difficult.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 0 0
2148 - Blacktown

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Western Sydney Local Health District
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Paul Keall, PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After study completion and publication, de-identified (non-coded, non-reidentifiable) data and medical images may be shared publicly with researchers for further scientific research. This will ensure that the potential of the data acquired in this trial is maximised. This is in accordance with the NHMRC guidelines on the publication and dissemination of research, and in line with archives, e.g. the TCIA (https://www.cancerimagingarchive.net/).

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
After study completion and publication, indefinitely.
Available to whom?
Data stored at the university: (i) that the data is not to be published or otherwise redistributed without the express consent of the original investigator(s) and (ii) that the data is forbidden to be used for any commercial purpose and (iii) the research is approved by an accredited ethics committee.

Data stored at an external repository: Study data that are provided to an external research data repository will be stored at and managed by the external repository. Data will only be shared with repositories whose function has been reviewed and approved by an accredited Research Integrity/Ethics Committee/Board under a Materials Transfer Agreement with the university.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05218824