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NCT Number: NCT06399172

OncoSil Pancreatic Cancer Post-marketing Clinical Registry - Italy

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.

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Key information

Conditions

Locally Advanced Pancreatic Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

OncoSil

Device

Intra-tumoural implantation

Primary outcomes

  1. Safety and tolerability

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

    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.

  2. Tumour response

    Time frame: 1 year

    Target (implanted) tumour response (local and distant)

  3. Device implantation Performance

    Time frame: 1 year

    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.

  4. Overall Survival

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

    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.

  5. Resection Rates

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

    Surgical resection rates and outcome

Sponsors and collaborators

Lead sponsor

OncoSil Medical Limited

Industry

Registry information

Official study title

OncoSil Pancreatic Cancer Post-marketing Clinical Registry Italy

Acronym: OSPRItaly

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
May 3, 2024
Registry last updated
May 3, 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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