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Trial registered on ANZCTR


Registration number
ACTRN12605000428662
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
16/09/2005
Date last updated
16/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Radiation Exposure and Safety of Lymphatic Mapping and Selective (Sentinel) Lymph Node Biopsy Procedures for Melanoma and Breast Cancer Treatment
Scientific title
Radiation Exposure and Safety of Lymphatic Mapping and Selective (Sentinel) Lymph Node Biopsy Procedures for Melanoma and Breast Cancer Treatment
Universal Trial Number (UTN)
Trial acronym
Radiation Safety in Sentinel N
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Stage I/II Melanoma 537 0
Breast Cancer 538 0
Condition category
Condition code
Cancer 617 617 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of the study was to evaluate radiation exposure and safety for staff in the treatment of patients with Early Stage I/II Melanoma and Breast Cancer using Lymphatic Mapping and Selective (Sentinel) Lymph Node Biopsy. This treatment has shown a high degree of safety with very few adverse events. The radiation exposure was studied during surgery and during transport and processing of specimens.
Intervention code [1] 533 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 721 0
To determine exposure during Selective (Sentinel) Lymph Node Biopsy procedures
Timepoint [1] 721 0
Evaluated during and for 24 hours after the procedures.
Primary outcome [2] 722 0
To determine safety during Selective (Sentinel) Lymph Node Biopsy procedures
Timepoint [2] 722 0
Evaluated during and for 24 hours after the procedures.
Secondary outcome [1] 1483 0
The secondary outcome was to determine possible associations between procedure duration and handling, exposure level and safety.
Timepoint [1] 1483 0

Eligibility
Key inclusion criteria
Stage I and II cutaneous melanoma > 1mm in Breslow thickness or > Clark Level III; Stage I and II Breast Cancer; Absence of Metastases; Informed Consent.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy; Other malignancy.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)

Funding & Sponsors
Funding source category [1] 675 0
Other
Name [1] 675 0
Address [1] 675 0
Country [1] 675 0
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital/University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 564 0
Individual
Name [1] 564 0
Assoc Professor BJ Coventry
Address [1] 564 0
Country [1] 564 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1856 0
Royal Adelaide Hospital/University of Adelaide
Ethics committee address [1] 1856 0
Ethics committee country [1] 1856 0
Australia
Date submitted for ethics approval [1] 1856 0
Approval date [1] 1856 0
Ethics approval number [1] 1856 0

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

Contacts
Principal investigator
Name 36233 0
Address 36233 0
Country 36233 0
Phone 36233 0
Fax 36233 0
Email 36233 0
Contact person for public queries
Name 9722 0
Ms Nicki Bator
Address 9722 0
Adelaide Melanoma Unit
Department of Surgery
University of Adelaide
Royal Adelaide Hospital
L5 Eleanor Harrold Building (EHB)
North Terrace
Adelaide SA 5000
Country 9722 0
Australia
Phone 9722 0
+61 8 82224154
Fax 9722 0
+61 8 82225896
Email 9722 0
nbator@mail.rah.sa.gov.au
Contact person for scientific queries
Name 650 0
Associate Professor Brendan Coventry
Address 650 0
Adelaide Melanoma Unit
Department of Surgery
University of Adelaide
Royal Adelaide Hospital
L5 Eleanor Harrold Building (EHB)
North Terrace
Adelaide SA 5000
Country 650 0
Australia
Phone 650 0
+61 8 82224154
Fax 650 0
+61 8 8222 5896
Email 650 0
bcoventry@medicine.adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary