NCT05967143Recruiting
Observational SIR-Spheres Study for the Treatment of Unresectable Liver Tumors (SIRtain Registry)
Observational Study to Assess Real-World Outcomes in Patients With Unresectable Liver Tumors Initiating Treatment With SIR-Spheres (Y-90 Resin Microspheres) (SIRtain Registry)
Source: ClinicalTrials.gov · Last updated 27 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This registry seeks to prospectively gather a large repository of comprehensive observational data reflecting routine use of SIR-Spheres in patients diagnosed with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy, in order to assess clinical response in a real-world setting and further validate the safe and appropriate use of SIR-Spheres
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 845 (estimated)
- First submitted
- 7 Jul 2023
- Start date
- 19 Jun 2023
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Sirtex Medical
- NCT number
- NCT05967143
What you commit to
- Study type: Observational
- Planned participants: 845
- From 19 Jun 2023 to the primary completion date, 30 Jun 2028
- 9 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiation treatment to the liver
- Caveat:
- Sequential selective internal radiation therapy (SIRT) treatment is allowed
- Patients participating in any interventional clinical trial with an investigational product, device, or procedure
Other
- Need for surrogate consent. Patients who are not able to consent on behalf of themselves are not eligible.
Who the study is looking for
- Age 18 years or older
- Confirmed diagnosis of:
- Unresectable hepatocellular carcinoma (HCC) Or
- Unresectable liver metastases from colorectal cancer (mCRC) refractory to or intolerant to chemotherapy
- Identified as a candidate for SIR-Spheres treatment as deemed appropriate during the normal course of practice
- Planned to receive SIR-Spheres treatment to the liver for the first time
- Provision of signed patient informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Puerta de Hierro - Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Not yet recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Not yet recruiting |
| Hopital Beaujon Coordinator of this site? Confirm its status | Clichy | France | Recruiting |
| Hopital Henri Mondor Coordinator of this site? Confirm its status | Créteil | France | Not yet recruiting |
| Hospices Civils De Lyon (hcl) -Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| Hammersmith Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| Kings College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| The Christie Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.