Sentinel lymph node biopsy feasibility study in patients with primary cutaneous melanoma
| ISRCTN | ISRCTN80602070 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80602070 |
| Protocol serial number | N/A |
| Sponsor | Sponsor not defined - Record supplied by Institute of Cancer Research |
| Funder | Cancer Research UK (CRUK) (UK) |
- Submission date
- 01/10/2004
- Registration date
- 10/01/2005
- Last edited
- 26/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Dr Tim Eisen
Scientific
Scientific
Department of Medicine
Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom
| Phone | +44 1223 40 41 91 |
|---|---|
| tim.eisen@icr.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Sentinel lymph node biopsy feasibility study in patients with primary cutaneous melanoma |
| Study acronym | SLNB |
| Study objectives | To compare the overall and disease-free survival in patients with a positive lymph node at biopsy. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Melanoma |
| Intervention | Completion lymphadenectomy versus no surgery |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 13/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 120 |
| Key inclusion criteria | 1. Patients must have clinical stage I or II invasive cutaneous melanoma with Breslow thickness greater than 1.0 mm and be suitable for lymphadenectomy surgery 2. The primary site must be on the trunk, limbs or digits. Patients with a primary melanoma involving the ear, eye or mucous membranes are not eligible. 3. Primary excision must have been within 90 days prior to the initial clinic visit 4. Subjects must be at least 18 years old 5. Karnovsky performance status greater than 70% 6. Women of childbearing age must have a negative pregnancy test 7. Subjects must voluntarily sign an informed consent form before study entry and agree to complete follow-up assessments 8. Adequate bone marrow, renal and hepatic function |
| Key exclusion criteria | 1. Wide local excision of the primary tumour with greater than 1 cm excision margins before SLNB. Patients may have SLNB and still be eligible for excision margin studies after SLNB. 2. Clinical evidence of satellite, in-transit, regional nodal or distant metastases 3. A second primary invasive melanoma 4. Any malignancy in the past 5 years, except squamous cell carcinoma of the skin, basal cell carcinoma, in situ carcinoma of the uterine cervix, or Stage I laryngeal carcinoma 5. Prior surgery in the region of the primary draining nodal basin that would disrupt normal lymphatic drainage patterns 6. Previous chemotherapy, immunotherapy or radiation therapy 7. Pregnancy or breast feeding 8. Known hypersensitivity to 99mTc-nanocolloid or patent blue dye. 9. History of any severe medical condition that is a significant risk to the participant leading to a life expectancy of less than 10 years prior to diagnosis of melanoma |
| Date of first enrolment | 01/09/2002 |
| Date of final enrolment | 13/10/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Royal Marsden Hospital
Sutton
SM2 5PT
United Kingdom
SM2 5PT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
26/04/2018: No publications found.
23/03/2016: No publications found, verifying study status with principal investigator.
