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CompletedLast updated: 21 December 2023

Sentinal: This trial will collect data following a sentinal node biopsy in patients with vulval carcinomaProspective collection of clinical data following sentinel node biopsy for vulval carcinoma in Australia and New Zealand

Clinical summary

Summary

This study aims to prospectively collect clinical data following sentinel node biopsy for vulval carcinoma in Australia and New Zealand. You may be eligible to join this study if you are a female aged 18 years or above with histologically confirmed, unifocal invasive squamous cell carcinoma of vulva less than 4cm in greatest dimension. Women in Australia and New Zealand women with early vulval cancer will be offered sentinel node procedures in place of groin node dissection. On the day before or the morning of your operation, you will have a small injection of a radioactive marker into the skin next to the cancer. A local anaesthetic cream will be used to reduce any discomfort from this injection. Pictures will then be taken over the next 2 1/2 hours to see which glands the marker has spread to. The marker will also help us find the ‘sentinel nodes’ during your operation. Either on the afternoon after the injection or the next day you will have your operation as planned by your doctor. Whilst you are asleep we will inject some blue dye around the cancer which will also help us to identify the sentinel glands. During the 60 minute operation we will remove the cancer. We will identify and remove the sentinel lymph gland(s) from one or both groins. When sentinel nodes in one or two groins can not be identified a full removal of the groin nodes (lymphadenectomy) on either one or both sides will be performed. The gland(s) will be sent to the laboratory for detailed assessment by the pathologist. Follow up clinical data will be collected from your clinical records at 3, 12, 24 and 36 months after surgery, from information obtained when you attend outpatients clinic. The majority of women with early vulval carcinoma do not have groin node metastasis and these women are unlikely to benefit from groin node dissection. The use of sentinel node dissection is safe and should be part of the standard treatment for women with early stage vulvar cancer.

Conditions

This trial is treating patients with Vulval Carcinoma.

Cancer

Female Reproductive System Cancers Gynaecological

Age

People18+

Phase

Not applicable

Trial Acronym

Sentinal

More information

Trial Identifiers

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Trial sponsor

Royal Women's Hospital

Scientific Title

Prospective collection of clinical data following sentinel node biopsy for vulval carcinoma in Australia and New Zealand

Eligibility

Inclusion

.1. Able to give informed consent.
2. Early vulval carcinoma confirmed histologically (unifocal, invasive squamous cell carcinoma less than 4cm in greatest dimension - not including insitu component)
3. Depth of invasion greater than 1mm

Exclusion

1. Tumour involves urethra, anus or middle 1/3 of vagina.
2. Reconstruction of the vulva using a flap has been performed with removal of the
primary lesion .
3. Clinical evidence of groin node metastasis.(palpation, imaging , FNA)
4. Prior history of SCC of the genital tract, anus, or lower body.
5. Prior groin node dissection

Inclusion

  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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