OncoSil Pancreatic Cancer Post-marketing Clinical Registry - Italy

NCT06399172 | Not Yet Recruiting DMC

• 1 other identifier: OSPRItaly01
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The OSPRItaly Patient Registry has been developed to assess the performance and safety of the OncoSil™ device when used within the approved indication of unresectable, locally advanced pancreatic cancer, in combination with gemcitabine-based chemotherapy, within a real-world observational registry.

Conditions

Locally Advanced Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (5)

• Safety and tolerability

  The analysis for safety within the real-world setting will be performed. The safety of OncoSil™ is defined by the Adverse Event profile. All safety summaries will be produced for the Intention-To-Treat (ITT) population. Adverse Device Effects will be coded using Medical Dictionary for Regulatory Activities (MedDRA). All Adverse Device Effects recorded during the Registry will be listed. Summary tables will be produced for Treatment Emergent Adverse Device Effects (TEADEs). The number and percentage of patients with device-related Adverse Events by system organ class (SOC) and preferred term will be tabulated. Similar summaries will be produced by severity of event (both mild, moderate or severe, CTCAE grade 1-4) and device relationship. In addition, summary tables will be produced for serious TEADEs and TEADEs associated with special interest acute/late radiation effects and or withdrawal.

  Followed to death or to 24-months after the date of the last enrolled patient.

• Tumour response

  Target (implanted) tumour response (local and distant)

  1 year

• Device implantation Performance

  Safety of the implantation of OncoSil™ within the target tumour will be measured by means of procedure-related Adverse Events. Ease of administration and implantation related data from user questionnaires will be assessed.

  1 year

• Overall Survival

  Overall survival (OS) is defined as the time from enrolment to the date of death from any cause. Patients who are alive or permanently lost to follow-up at the cut-off date for the analysis will be censored at the last date the patient was known to be alive.

  Followed to death or to 24-months after the date of the last enrolled patient

• Resection Rates

  Surgical resection rates and outcome

  Followed to death or 24 months after the date of the last enrolled patient

Interventions

OncoSil DEVICE

Intra-tumoural implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In the participating institutions every patient who is intended to undergo implantation of the OncoSil™ device when used within the approved indication of unresectable, locally advanced pancreatic cancer, in combination with gemcitabine-based chemotherapy, in the commercial (sales) setting will be approached by the Principal Investigator (or delegate) to consent to participate in the OSPRItaly Patient Registry.

You may qualify if:

• Patients who are eligible for and undergo OncoSil™ implantation at an eligible treatment facility according to the approved OncoSil™ System Instructions for Use (IFU), as part of their clinical care.
• Patients who have completed and signed the Patient Informed Consent Form (PICF) for the OSPRItaly Patient Registry.

You may not qualify if:

• Patients participating in an interventional clinical study (company or investigator-sponsored).
• Use of an investigational agent at the time of enrolment.

Sponsors & Collaborators

• OncoSil Medical Limited: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 3, 2024
• Study Start: May 30, 2024
• Primary Completion (Estimated): May 30, 2029
• Study Completion (Estimated): October 30, 2029
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share