Checking Lymph Nodes After Cancers Around the Eye

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with certain cancers of the eye surface or the tissue around the eye, who have no signs of spread to lymph nodes. They will have a sentinel lymph node biopsy.

Age

From 18 years to 95 years.

Sex

All sexes can join.

Disease stage

Sebaceous carcinoma, Merkel cell carcinoma or porocarcinoma (all patients). Conjunctival melanoma, new or returned, including with primary acquired melanosis with atypia. Skin melanoma around the eye with thickness ≥1.5 mm, Clark's level ≥3 and >1 mitotic figure per high-power field. Squamous cell cancer around the eye with Staging ≥3, locally returned, or with perineural invasion. Squamous cell cancer of the eye surface with Staging ≥3 and/or multicenter. Lymph nodes clinically free of cancer (cNo).

Earlier treatment

The record does not require or forbid any earlier treatment. Cancers that came back after surgery or radiation-chemotherapy are included.

Main reasons for not taking part

• Under 18 years of age
• Cancer that has already spread (metastatic) at diagnosis
• Does not fit the inclusion criteria
• Informed consent not given

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 95 years old?YesNo

What the trial wants to find out

The study involves enrollment of patients with sebaceous carcinoma, Merkel's carcinoma, Porocarcinoma, Melanoma, and squamous cell Ca of the ocular surface and adnexa both primary and relapsed after surgical and/or radiation-chemotherapy treatment at the Fondazione Policlinico Universitario A. Gemelli, IRCCS. The study will last 9 years: 1 year will be devoted to the first phase of the study. Patient enrollment will continue for an additional 3 years, and 5 years will be devoted overall to patient follow-up so that survival outcomes at 1-3 and 5 years can be assessed in a congruent number of patients. A preliminary analysis of the data at 1 year (pilot phase), an analysis at 4 years to confirm the preliminary study data on a larger sample, and a final analysis to evaluate OS and PFS at the 3 time-points indicated are planned.

The 5 groups in the trial

• Sebaceous carcinoma

  patients with sebaceous carcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS

  Treatment: Sentinel Lymph Node Biopsy

• Merkel's carcinoma

  patients with Merkel's carcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS

  Treatment: Sentinel Lymph Node Biopsy

• Porocarcinoma

  patients with Porocarcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS

  Treatment: Sentinel Lymph Node Biopsy

• Conjunctival Melanoma

  patients with Conjunctival Melanoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS

  Treatment: Sentinel Lymph Node Biopsy

• Squamous cell Carcinoma

  patients with squamous cell Carcinoma of the ocular surface and adnexa both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS

  Treatment: Sentinel Lymph Node Biopsy