NCT06309836

Brief Summary

Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Jun 2021Dec 2029

Study Start

First participant enrolled

June 23, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2023

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

8.5 years

First QC Date

August 4, 2023

Last Update Submit

June 9, 2025

Conditions

Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • clinical evolution, treatment and prognosis

    clinical profile of patient, the phenotypic and behavioural characteristic and the clinical course from baseline to follow-up.

    from baseline through study completion, an average of 3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with advanced basal cell carcinoma of the skin

You may qualify if:

  • Male and female patients aged ≥ 18 years
  • Patients diagnosed with advanced basal cell carcinoma of the skin, i.e. tumours included in at least one of the following categories: locally advanced carcinoma (not radically treatable by surgery and/or radiotherapy), carcinoma with lymph node and/or distant metastatic localisation
  • patients who have had at least one access (first visit or follow-up visit) at the dermatology or oncology outpatient clinic of the centres involved
  • Patients diagnosed with advanced BCC who have accessed the centre from 1 January 2016 until the date of activation of the centre will be included in the retrospective cohort;
  • Patients diagnosed with advanced BCC who have accessed the centre from the date of activation
  • Signature of informed consent

You may not qualify if:

  • Patients incapable of giving informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irccs Fondazione Policlinico Gemelli

Roma, ITA, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Study Officials

  • Ketty MD Peris

    IRCCS FONDAZIONE POLICLINICO GEMELLI

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ketty MD Peris

CONTACT

0630154211ketty.peris@unicatt.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2023

First Posted

March 13, 2024

Study Start

June 23, 2021

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

June 12, 2025

Record last verified: 2025-06

Locations

IT(1)