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NCT Number: NCT05797415

Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers

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.

Recruiting

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Key information

About this study

Patients will undergo:

  • Evaluation in the ocular oncology outpatient clinic with examination and anterior segment photography
  • Staging according to TNM AJCC 8th edition by incisional biopsy (if necessary after clinical evaluation) and/or excisional biopsy and imaging to be performed in current clinical practice (MRI with mdc orbits, massif and neck + Tc/Pet total body)
  • Injection of 99mTc-labeled nanocolloids
  • Preoperative lymphoscintigraphy
  • Intraoperative search by gamma probe of the sentinel lymph node
  • Sentinel lymph node biopsy
  • Excisional biopsy of the neoformation in cases not undergoing excision before SLN biopsy.
  • In case of SLN histologic positivity, the multidisciplinary team will consider whether to refer the patient for parotidectomy and excision of the lymph node chain and/or adjuvant radio/chemotherapy.
  • Clinical-instrumental follow-up to be performed in current clinical practice (Clinical examination, cranial orbit and neck MRI, total body CT scan) at 3, 6, 12, 18, 24, 36, 48, 60 months or according to periodicity assessed on a case-by-case basis by the Tumor Board.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients with Porocarcinoma, Ca of Merkel, Ca Sebaceous
  • Patients with cutaneous adnexal melanoma with thickness ≥1.5 mm, Clark's level ≥3, >1 mitotic figure per high-power field.
  • Patients with conjunctival melanoma both primary and recurrent and associated with primary acquired melanosis with atypia.
  • Patients with squamous cell Ca of adnexa with Staging ≥3, locally recurrent or with perineural invasion
  • Patients with squamous cell Ca of the surface with Staging ≥3 and/or multicenter
  • Signature of informed consent to participate in the study
  • cNo

Exclusion criteria

  • Age less than 18 years
  • Patients with metastatic disease at diagnosis
  • All patients who do not fit the inclusion criteria
  • Failure to obtain informed consent

Treatment and study plan

Sentinel Lymph Node Biopsy

Procedure
  • Injection of 99mTc-labeled nanocolloids
  • Preoperative lymphoscintigraphy
  • Intraoperative gamma probe search of the sentinel lymph node
  • Sentinel lymph node biopsy
  • Excisional biopsy of the neoformation in cases not undergoing excision before SLN biopsy.
  • If the SLN is histologically positive, the multidisciplinary team will consider whether to refer the patient for parotidectomy and excision of the lymph node chain and/or adjuvant radio/chemotherapy.

Primary outcomes

  1. Efficacy of lymphoscintigraphic examination and SLN biopsy

    Time frame: 9 years

    Positive predictive value (PPV) and negative predictive value (NPV), in percentage, in order to determine the likelihood of lymphoscintigraphic examination and SLN biopsy in diagnosing Ocular Surface and Adnexal Cancers.

  2. Efficacy of lymphoscintigraphic examination and SLN biopsy

    Time frame: 9 years

    Sensitivity and sensibility, in percentage, in order to determine the likelihood of lymphoscintigraphic examination and SLN biopsy in diagnosing Ocular Surface and Adnexal Cancers.

Secondary outcomes

  1. Overall survival (OS)

    Time frame: 5 years

    OS (in years) at 1, 3, and 5 years

  2. Diseases Free Survival (DFS)

    Time frame: 5 years

    DFS (in years) at 1,3 and 5 years

  3. Progression Free Survival (PFS)

    Time frame: 5 years

    PFS (in years) at 1, 3, and 5 years

  4. Changes in clinical parameter (tumor diameters)

    Time frame: 60 months

    Changes in clinical parameter (tumor diameters) of patients at follow-up (3, 6, 12, 24, 36, 48, 60 months)

Study contacts

Contact information is provided by the study sponsor or research team.

Gustavo Savino, MD

CONTACT

[email protected]

0630154528

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers: Prospective Observational Study

Acronym: BLS

Important dates

Study start
2023
Primary completion
2025
Study completion
2032
First posted
Apr 4, 2023
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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