MelanomaAIQ TRAQinformNCT05819255
TRAQinform Assessment of Immunotherapy Response
An observational study of Melanoma, run by AIQ Solutions at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Non-Interventional
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jun 2023to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic melanoma.
Who may be able to join
- 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.
Who cannot join
- 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.
- A second malignancy
- Pregnancy or women who are breast feeding
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
About this study
Official title: Comprehensive Assessment of Cancer Immunotherapy Response; Investigating the Intent to Change Treatment Decisions Based Upon TRAQinform Immuno Technology
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).
Read the detailed description
This prospective, non-interventional clinical study will enroll patients with metastatic melanoma, who have been selected by their oncologist to receive standard of care (SOC) dual-agent immunotherapy and monitored for treatment response using SOC FDG PET/CTs.
The primary objective of this clinical study is to investigate intent to change treatment decisions after the addition of treatment response information from the TRAQinform Immuno technology. For each subject, FDG PET/CT #1, #2 and #3 will be transmitted to AIQ Solutions (Madison, WI) for treatment response analysis using TRAQinform Immuno, a software technology that identifies, matches and quantifies metastatic cancer regions of interest. A TRAQinform Immuno report will be returned to the oncology/nuclear medicine paired investigator teams, after the first clinical decision point following FDG PET/CT #1 and #2 and again after the second clinical decision point following FDG PET/CT #3. The investigator team at each site will complete an "intent to change" questionnaire for each subject at Data Collection Point #1 and at Data Collection Point #2. The clinical study will evaluate the Data Collection Point questionnaires to help understand the clinical impact of the addition of TRAQinform Immuno analysis into the clinical workflow.
To address the status quo bias of the investigator teams, the TRAQinform Immuno reports for subjects enrolled at each site, including the additional limited data that is necessary to make a treatment decision, will be shared between teams. The first investigator team, without knowledge of the treatment decision made by the second investigator team, will independently answer the Data Collection Point #3 questionnaire and vice versa.
An exploratory objective of this clinical trial is to investigate if treatment effectiveness and adverse events could be detected on FDG PET/CT images at 3-4 weeks of the combination immunotherapy.
- Conditions
- Melanoma
- Being tested
- Non-Interventional
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
This prospective, non-interventional clinical study will enroll patients with metastatic melanoma, who have been selected by their oncologist to receive standard of care dual-agent immunotherapy and monitored for treatment response using SOC FDG PET/CTs.
The primary objective of this clinical study is to investigate intent to change treatment decisions after the addition of treatment response information from the TRAQinform Immuno technology.
What is being measured
The primary outcome is the main question the study is designed to answer.
To Investigate Intent to Change Treatment Decisions.
Treatment response will be analyzed using TRAQinform Immuno Technology which is a software technology that identifies, matches, and quantifies metastatic cancer regions of interest. The clinical study will evaluate investigator questionaries to help understand the clinical impact of the addition of the TRAQinform Immuno analysis into the clinical work flow.
Measured: 12 weeks
Secondary outcomes (1)
Adverse Events and Treatment Efficacy Prediction
To investigate if treatment effectiveness and adverse events can be detected on week 3-4 FDG PET/CT. An additional FDG PET/CT will be obtained on all subjects between weeks three and four to evaluate if TRAQinform Immuno can predict adverse events and treatment effectiveness.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start23 Jun 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIQ Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), Massachusetts General Hospital, University of Wisconsin, Madison
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819255
- Sponsor's protocol ID
- AIQ 22-583
- Other IDs
- 2R44CA257253
- Acronym
- AIQ TRAQinform
- Status last verified
- Aug 2025
- First submitted
- 6 Apr 2023
- Last updated
- 28 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Assessment of Cancer Immunotherapy Response; Investigating the Intent to Change Treatment Decisions Based Upon TRAQinform Immuno Technology
- ClinicalTrials.gov ID
- NCT05819255
- Acronym / sponsor ID
- AIQ TRAQinform / AIQ 22-583
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- AIQ SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), Massachusetts General Hospital, University of Wisconsin, Madison
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This prospective, non-interventional clinical study will enroll patients with metastatic melanoma, who have been selected by their oncologist to receive standard of care (SOC) dual-agent immunotherapy and monitored for treatment response using SOC FDG PET/CTs.
The primary objective of this clinical study is to investigate intent to change treatment decisions after the addition of treatment response information from the TRAQinform Immuno technology. For each subject, FDG PET/CT #1, #2 and #3 will be transmitted to AIQ Solutions (Madison, WI) for treatment response analysis using TRAQinform Immuno, a software technology that identifies, matches and quantifies metastatic cancer regions of interest. A TRAQinform Immuno report will be returned to the oncology/nuclear medicine paired investigator teams, after the first clinical decision point following FDG PET/CT #1 and #2 and again after the second clinical decision point following FDG PET/CT #3. The investigator team at each site will complete an "intent to change" questionnaire for each subject at Data Collection Point #1 and at Data Collection Point #2. The clinical study will evaluate the Data Collection Point questionnaires to help understand the clinical impact of the addition of TRAQinform Immuno analysis into the clinical workflow.
To address the status quo bias of the investigator teams, the TRAQinform Immuno reports for subjects enrolled at each site, including the additional limited data that is necessary to make a treatment decision, will be shared between teams. The first investigator team, without knowledge of the treatment decision made by the second investigator team, will independently answer the Data Collection Point #3 questionnaire and vice versa.
An exploratory objective of this clinical trial is to investigate if treatment effectiveness and adverse events could be detected on FDG PET/CT images at 3-4 weeks of the combination immunotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic melanoma.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
- A second malignancy
- Pregnancy or women who are breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionalThis prospective, non-interventional clinical study will enroll patients with metastatic melanoma, who have been selected by their oncologist to receive standard of care dual-agent immunotherapy and monitored for treatment response using SOC FDG PET/CTs. The primary objective of this clinical study is to investigate intent to change treatment decisions after the addition of treatment response information from the TRAQinform Immuno technology. | Other | – |
Primary outcome
To Investigate Intent to Change Treatment Decisions.
Time frame: 12 weeks
Treatment response will be analyzed using TRAQinform Immuno Technology which is a software technology that identifies, matches, and quantifies metastatic cancer regions of interest. The clinical study will evaluate investigator questionaries to help understand the clinical impact of the addition of the TRAQinform Immuno analysis into the clinical work flow.
1 secondary outcome
Adverse Events and Treatment Efficacy Prediction
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by AIQ Solutions at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Investigate Intent to Change Treatment Decisions. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.