Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000528257
Ethics application status
Approved
Date submitted
29/12/2015
Date registered
10/04/2018
Date last updated
2/03/2023
Date data sharing statement initially provided
22/03/2019
Date results information initially provided
2/03/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Biopsy ME study - Node biopsy for patients with early stage Merkel Cell Carcinoma,
Scientific title
Sentinel Lymph Node Biopsy (SLNB) in Early-stage (cT1N0) Merkel Cell Carcinoma (MCC) to estimate the rate of SLNB positivity in cT1N0 MCC
Secondary ID [1] 288224 0
none
Universal Trial Number (UTN)
Trial acronym
Biopsy ME Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early stage (cT1N0) Merkel Cell Carcinoma 297140 0
Condition category
Condition code
Cancer 297368 297368 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
Observational study only, no intervention
Early stage Merkel Cell Carcinoma with Sentinel Lymph Node Biopsy performed, patients will undergo radiotherapy as required and be followed up for at least 2 years.
Intervention code [1] 293516 0
Not applicable
Comparator / control treatment
Observational study only, no intervention, no control group is required.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296920 0
To estimate the rate of sentinel lymph node positivity in cT1N0 Merkel cell carcinoma, all patients in the study will have undergone a SLNB
Timepoint [1] 296920 0
SLNB is performed at baseline.
Primary outcome [2] 296921 0
Record the location of SLN identified, with reference to the location of the primary site
Timepoint [2] 296921 0
Recorded post SLNB at the 6 week post radiotherapy visit.
Primary outcome [3] 296922 0
Among the sentinel lymph node-negative patients, who are treated with radiotherapy to the primary site alone - to estimate the proportion of patients experiencing regional recurrence and/or death within two years. (Composite outcome)
Patients will undergo standard follow up including Ultrasounds of the nodal basin and scanning.
Timepoint [3] 296922 0
Patients will be followed up 6 weeks after Radiotherapy, then every 4 months for a minimum of 2 years.
Secondary outcome [1] 319709 0
Amongst patients who experienced recurrence within two years, to estimate the proportion of patients for whom sentinel lymph node mapping / biopsy was able to correctly identify the location of the lymph node region in which the recurrence was detected.
Timepoint [1] 319709 0
Patients will be followed up on a 4 monthly basis post Radiotherapy completion for a minimum of 2 years,

Eligibility
Key inclusion criteria
Patients (male or female) above 18 years old
Histologically documented cutaneous MCC, stage cT1N0
Suitable for sentinel lymph node biopsy
No clinical evidence of regional or distant metastases.
Patients must undergo treatment and follow up at Peter MacCallum Cancer Centre, Melbourne or the Liverpool hospital, Sydney.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Proven metastatic disease
Patients who refuse radiotherapy
Patients who refuse to join the trial or are unable to consent
Patients not being considered for further therapy
Patients who cannot lie still for at least 30 minutes or comply with imaging
Technically unsuitable for for lymphoscintigraphy/ SNB procedure
Pregnancy/Lactation

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Expected accrual is 10 patients per 12 months, resulting in 50 patients over a 5 year period
1. Amongst patients for whom the sentinel lymph node (SLN) could be identified, the proportion of cT1N0 patients with disease detected in the SLN will be estimated as a binary proportion together with its CI, by an exact method.
2. For each primary disease site (leg, arm, etc.) the number of patients for whom the location of the SLN is in each possible location (axilla, groin, neck or other) will be tabulated. For patients for whom the primary site drains to multiple lymph nodes i.e. multiple SLN’s), all drainage sites will be considered in the tabulation.
3. For SLN-negative patients, initial therapy consists of radiotherapy to the primary disease site. After initial therapy all patients are expected to be disease-free (with reference to the LN region). The Kaplan-Meier estimate of the proportion of patients experiencing regional recurrence within two years, together with its 95% CI will be provided. Death will be a censoring event.
4. For those patients for whom the SLN could be identified and for whom regional recurrence occurred within 2 years, the proportion of patients for whom the recurrence occurred in the lymph node region in which the SLN was found, will be estimated as a binary proportion, and a 95% CI for this proportion will be provided using an exact method

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
18/12/2015
Date of last participant enrolment
Anticipated
31/12/2020
Actual
16/11/2021
Date of last data collection
Anticipated
18/01/2027
Actual
Sample size
Target
50
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 10421 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 10422 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 22110 0
3000 - Melbourne
Recruitment postcode(s) [2] 22111 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 292609 0
Hospital
Name [1] 292609 0
Peter MacCallum Cancer Centre
Country [1] 292609 0
Australia
Primary sponsor type
Hospital
Name
South Western Sydney Local Health District
Address
Campbell Street, Liverpool, NSW, 2170
Country
Australia
Secondary sponsor category [1] 291329 0
None
Name [1] 291329 0
none
Address [1] 291329 0
none
Country [1] 291329 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294090 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 294090 0
Grattan Street Melbourne, VIC, 3000
Ethics committee country [1] 294090 0
Australia
Date submitted for ethics approval [1] 294090 0
Approval date [1] 294090 0
05/11/2015
Ethics approval number [1] 294090 0
15/57
Ethics committee name [2] 312540 0
South Western Sydney Local Health District
Ethics committee address [2] 312540 0
Administration Building, Eastern Campus, Liverpool Hospital,
Locked Bag 7279, Liverpool BC 1871
Ethics committee country [2] 312540 0
Australia
Date submitted for ethics approval [2] 312540 0
20/10/2021
Approval date [2] 312540 0
08/11/2021
Ethics approval number [2] 312540 0
61978

Summary
Brief summary
The broad objective of this study is to document and assess the utility of current institutional standard-practice staging procedures for patients with early-stage Merkel cell carcinoma, who are managed at Peter MacCallum Cancer Centre (PMCC) or Liverpool Hospital

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and have histologically documented cutaneous Merkel cell carcinoma (MCC), stage cT1N0, which is suitable for sentinel lymph node biopsy.

Study details
Participants in this study undergo standard institutional practice, which involves sentinel lymph node biopsy (SLNB)/ lymphatic mapping and 18F-FDG PET/CT at initial diagnosis.
SLNB involves removal and examination of the sentinel node(s) (the first lymph node(s) to which cancer cells are likely to spread from a primary tumor, This involves injection of a radioactive substance, blue dye, or both near the tumor, so that the node can be found using a probe or seen stained with dye. The surgeon then removes the sentinel node(s) to check for the presence of cancer cells.
PET/CT scanning involves a small amount of radioactive glucose (sugar) injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Because cancer cells often take up more glucose than normal cells, the pictures can be used to find cancer cells in the body.

Subsequent treatment of the tumour is undertaken with radiotherapy. Extent of radiotherapy treatment is determined by the results of the SLNB, i.e. if SLNB is negative patients receive treatment to the primary tumour site alone. If the SLNB is positive, patients will undergo treatment to both the primary and (involved) lymph node region.

Follow up involves clinical examination at 6 weeks after Radiotherapy, then assessment every 4 months with clinical examination and PET scans as per hospital policy for a minimum of 2 years. Patients with a negative sentinel node will also undergo an ultrasound of the area the lymph node was removed from at each visit.
Ultrasound involves a procedure that uses high-energy sound waves to look at tissues and organs inside the body. The sound waves make echoes that form pictures of the tissues and organs on a computer screen.
This study will provide valuable information to guide management for Merkel Cell Carcinoma. There is a lack of information regarding this uncommon, highly aggressive skin cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62422 0
Dr Meredith Johnston
Address 62422 0
Liverpool Hospital, Campbell St, Liverpool NSW 2170
Country 62422 0
Australia
Phone 62422 0
+61 2 87389806
Fax 62422 0
Email 62422 0
[email protected]
Contact person for public queries
Name 62423 0
Ms Penny Phan
Address 62423 0
Liverpool hospital. 1 Campbell St Liverpool NSW, Australia 2170
Country 62423 0
Australia
Phone 62423 0
+61 429094402
Fax 62423 0
Email 62423 0
[email protected]
Contact person for scientific queries
Name 62424 0
Dr Meredith Johnston
Address 62424 0
Liverpool Hospital, Campbell St, Liverpool NSW 2170
Country 62424 0
Australia
Phone 62424 0
+61 2 87389806
Fax 62424 0
Email 62424 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
to maintain patient confidentiality due to the small number of patients being enrolled


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.