NCT05819255Completed
TRAQinform Assessment of Immunotherapy Response
Comprehensive Assessment of Cancer Immunotherapy Response; Investigating the Intent to Change Treatment Decisions Based Upon TRAQinform Immuno Technology
Source: ClinicalTrials.gov · Last updated 28 Aug 2025
Brief summary (registry, in English)
The intent of this study is to evaluate the actionable information output from the TRAQinform Immuno technology in a prospective, non-interventional clinical study. Subjects with metastatic melanoma treated with standard of care (SOC) dual-agent immunotherapy will be enrolled. Subjects will receive SOC immunotherapy monitored for treatment response with FDG PET/CT's at baseline (SOC), after 3-4 weeks of treatment (non-SOC) and 12 at weeks of treatment (SOC).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 26 (actual)
- First submitted
- 6 Apr 2023
- Start date
- 23 Jun 2023
- Primary completion date
- 30 Apr 2025
- Lead sponsor
- AIQ Solutions
- Diseases
- Melanoma
- NCT number
- NCT05819255
What you commit to
- Study type: Observational
- Participants enrolled: 26
- From 23 Jun 2023 to the primary completion date, 30 Apr 2025
- 2 sites in 1 country
- 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
- Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial; places the patient at undue risk; or complicates the interpretation of the data, in the opinion of the investigator.
Other illness
- A second malignancy
Other
- Pregnancy or women who are breast feeding
Who the study is looking for
- Diagnosis of metastatic melanoma and is planned to start or has received one cycle of treatment with standard of care, dual-agent immunotherapy.
- Previous adjuvant anti-PD-I monotherapy is allowed. Patients must be greater than 6 months from the last treatment.
- Previous adjuvant BRAF/MEK therapy is allowed.
- Ability to tolerate 3 FDG PET/CT procedures. One at baseline, prior to the start of the combination immuno therapy, after 3 - 4 weeks of the combination immunotherapy treatment, and at 12 weeks of the combination treatment.
- Estimated life expectancy of greater than 12 months at screening.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at screening.
- Deemed suitable for starting standard of care combination immunotherapy for metastatic melanoma.
- Willing and able to provide informed consent for FDG PET/CT imaging.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Wisconsin Carbone Cancer Center Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.