Adult Patients Who Are Receiving Oncologic CareC-PAINNCT06511401
Informing Pain Treatment Using Pharmacogenomic Analysis
A study testing Pharmacogenomic (PGx) results. in people with Adult Patients Who Are Receiving Oncologic Care, run by University of Chicago at 1 site in United States.
Trial summary
This is a randomized, prospective study to evaluate the effects of preemptive pharmacogenomic (PGx) testing on opioid dosing decisions/selections and pain score in cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Patients Who Are Receiving Oncologic Care
- What is being tested?
- Pharmacogenomic (PGx) results.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2024to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Persons receiving ongoing oncology care at the University of Chicago Medical Center for whom near-future pain opioid pain medication therapy is anticipated
- Subjects must be at least 18 years of age.
Who cannot join
- Subjects taking an opioid at the time of enrollment, or within the past 30 days
- Subjects who are currently undergoing palliative radiation
- Subjects who have undergone, or are being actively considered for, bone marrow, liver or kidney transplantation.
- Subjects with a history of or active blood cancer (e.g., leukemia).
- Chronic kidney disease, as defined by Glomerular filtration rate (GFR) < 30/mL/min/1.73m2, due to the risk of decreased drug excretion.
- Liver dysfunction, as defined by the following laboratory values, due to the risk of decreased drug metabolism: Total bilirubin greater than or equal to1.5 mg/dL, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) greater than or equal to 2.5 X upper limit of normal*. (*Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \ greater than or equal to 5 X upper limit of normal if hepatic metastases are present).
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- Inability to understand and give informed consent to participate in the opinion of the investigator
- Subjects who are known to be pregnant at the time of enrollment
- Subjects who have previously or are currently enrolled in another institutional pharmacogenomic genotyping study, or are known to have previously undergone pharmacogenomic genotyping for the gene(s) of interest via another commercial or other means.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Clinical Trials Intake, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Peter O'Donnell
About this study
Official title: C-PAIN: Catalyzing Pharmacogenomic Analysis for Informing Pain Treatment
This is a randomized, prospective study to evaluate the effects of preemptive pharmacogenomic (PGx) testing on opioid dosing decisions/selections and pain score in cancer patients.
- Being tested
- Pharmacogenomic (PGx) results.
- Keywords
- Pharmacogenomic, Opioids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenomic (PGx) results.Other
These results are designed to provide specific dosing information based on the participant's unique genetics/genomics.
| Study group | Role | What they receive |
|---|---|---|
| PGx Arm | Experimental | PGX information is provided to clinicals to inform opioid dosing and selection. Receives: Other: Pharmacogenomic (PGx) results. |
| Control Arm | No intervention | No PGX information provided opioid dosing and selection is according to standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain control.
Measuring changes in composite pain intensity rating via the numeric rating scale:
- Brief Pain Inventory-Short Form (BPI-SF)
- Score range: 0 (no pain) to 10 (most pain)
- Composite pain intensity score (mean of worst, least, average, and current pain)
From baseline to day 45 in patients receiving an index opioid prescription for codeine, tramadol, or hydrocodone.
Measured: 45 days
Secondary outcomes (4)
Pain Medication Regimen Changes
Pain medication regimen changes will be assessed for patients who were taking an opioid metabolized primarily by CYP2D6. Pain medication regimen changes from baseline to day 45. The timing of subsequent changes in pain regimes after initial opioid selection will also be recorded.
Measured: 45 days
Hospitalization or Emergency Visit for Pain Control
The rates of hospitalization and emergency room visits for pain are examined with the rates of increased utilization of health care resources, such as emergency department visits, hospitalizations, and pain consultations. Rates of hospitalization or emergency room visits from baseline to day 45.
Measured: 45 days
Cumulative Morphine Equivalents Required
Cumulative Morphine Equivalents will be defined as total amount of opioids taken by a patient that is converted into its morphine equivalent. Dose and frequency of each opioid given during 45 days after its index prescription will be considered during calculation to give final values, which will be compared to Cumulative Morphine Equivalents for Control arms treated per standard of care.
Measured: 45 days
Type of First Opioid Prescribed
Measured: From enrollment until study end (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start30 Jul 2024
- Primary completion7 Jan 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Patients Who Are Receiving Oncologic CareStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Responsible party
- Sponsor
- Investigators
- Peter H O'Donnell, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511401
- Sponsor's protocol ID
- IRB24-0700
- Other IDs
- 1R01HG012273-01A1
- Acronym
- C-PAIN
- Status last verified
- Apr 2026
- First submitted
- 5 Jul 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C-PAIN: Catalyzing Pharmacogenomic Analysis for Informing Pain Treatment
- ClinicalTrials.gov ID
- NCT06511401
- Acronym / sponsor ID
- C-PAIN / IRB24-0700
- Keywords
- Pharmacogenomic, Opioids
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 7 Jan 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 22 Jul 2024 (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.
This is a randomized, prospective study to evaluate the effects of preemptive pharmacogenomic (PGx) testing on opioid dosing decisions/selections and pain score in cancer patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PGx Arm | Experimental | Other: Pharmacogenomic (PGx) results.PGX information is provided to clinicals to inform opioid dosing and selection. |
| Control Arm | No intervention | –No PGX information provided opioid dosing and selection is according to standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Persons receiving ongoing oncology care at the University of Chicago Medical Center for whom near-future pain opioid pain medication therapy is anticipated
- Subjects must be at least 18 years of age.
Key exclusion criteria (9 listed)
- Subjects taking an opioid at the time of enrollment, or within the past 30 days
- Subjects who are currently undergoing palliative radiation
- Subjects who have undergone, or are being actively considered for, bone marrow, liver or kidney transplantation.
- Subjects with a history of or active blood cancer (e.g., leukemia).
- Chronic kidney disease, as defined by Glomerular filtration rate (GFR) < 30/mL/min/1.73m2, due to the risk of decreased drug excretion.
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 |
|---|---|---|
| Pharmacogenomic (PGx) results.These results are designed to provide specific dosing information based on the participant's unique genetics/genomics. | Other | PGx Arm |
Primary outcome
Pain control.
Time frame: 45 days
Measuring changes in composite pain intensity rating via the numeric rating scale: * Brief Pain Inventory-Short Form (BPI-SF) * Score range: 0 (no pain) to 10 (most pain) * Composite pain intensity score (mean of worst, least, average, and current pain) From baseline to day 45 in patients receiving an index opioid prescription for codeine, tramadol, or hydrocodone.
4 secondary outcomes
Pain Medication Regimen Changes
Time frame: 45 days
Hospitalization or Emergency Visit for Pain Control
Time frame: 45 days
Cumulative Morphine Equivalents Required
Time frame: 45 days
Type of First Opioid Prescribed
Time frame: From enrollment until study end (up to 5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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.
Peter H O'Donnell principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacogenomic (PGx) results. in people with Adult Patients Who Are Receiving Oncologic Care, run by University of Chicago at 1 site 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 2 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Intake (1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain control. (time frame: 45 days). 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 4 May 2026.