Patients Undergoing Routine Health CareNCT01280825
The 1200 Patients Project: Studying the Implementation of Clinical Pharmacogenomic Testing
An observational study of Patients Undergoing Routine Health Care and Heart Diseases, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to collect DNA samples from patients undergoing routine care at the University of Chicago. These samples will be tested for differences in genes that may suggest greater risk of side effects or chance of increased benefit from certain medications. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patients Undergoing Routine Health Care, Heart Diseases, Inflammatory Bowel Diseases
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2011to 14 Dec 2027
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults receiving ongoing routine medical care and regularly using at least 1 (but no more than 6) prescription medications at the time of enrollment.
Who may be able to join
- Receiving ongoing, out-patient care at the University of Chicago Medical Center under the routine care of a physician participating in this trial
- Life expectancy of at least 3 years
- Must be 18 years or older
- Must be taking at least 1 (but not more than 6) prescription medications at the time of enrollment OR be 65 years or older OR be reasonably expected to require the use of a prescription medication within the next 5 years
- Patients with certain diseases, or likely to receive or be receiving certain drugs, will be targeted particularly for enrollment in order to enrich the study for patients likely to have pharmacogenetically relevant interactions, including, but not limited to:
- Patients requiring specialized cardiology care
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- Patients with inflammatory bowel diseases
- Patients with systemic autoimmune or inflammatory diseases
- Patients requiring long-term oral anticoagulation
- Patients with hepatitis C
- Patients with non-metastatic cancer
Who cannot join
- Patients with acute or chronic disease which could be reasonably expected to result in the patient's death within the next 3 years.
- Patients who have undergone, or are being actively considered for, liver or kidney transplantation.
- Inability to understand and give informed consent to participate.
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 Medical Center
Chicago, Illinois, 60637
About this study
The purpose of this study is to collect DNA samples from patients undergoing routine care at the University of Chicago. These samples will be tested for differences in genes that may suggest greater risk of side effects or chance of increased benefit from certain medications. The results will be made available to the patient's treating physician and the researchers will track whether or not this information is used in routine health care.
- Conditions
- Patients Undergoing Routine Health Care, Heart Diseases, Inflammatory Bowel Diseases, Autoimmune Disease, Inflammatory Disease, Blood Coagulation Disorders
- Medical subject headings
- Heart Diseases, Inflammatory Bowel Diseases, Autoimmune Diseases, Blood Coagulation Disorders, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult Patients | Adults receiving health care at the University of Chicago Medical Center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of incorporating pharmacogenomic testing into routine medical care
Measured: 5 years
Secondary outcomes (1)
Find out whether availability of pharmacogenomic information impacts drug decision making in the health care setting
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study start14 Jan 2011
- Primary completion14 Nov 2027 (estimated)
- Study completion14 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Routine Health 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter H O'Donnell, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280825
- Sponsor's protocol ID
- 10-487-A
- Status last verified
- Mar 2026
- First submitted
- 19 Jan 2011
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 1200 Patients Project: Studying the Implementation of Clinical Pharmacogenomic Testing
- ClinicalTrials.gov ID
- NCT01280825
- Acronym / sponsor ID
- 10-487-A
- Conditions
- Patients Undergoing Routine Health Care, Heart Diseases, Inflammatory Bowel Diseases, Autoimmune Disease, Inflammatory Disease, Blood Coagulation Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 14 Jan 2011 (actual)
- Primary completion
- 14 Nov 2027 (estimated)
- Study completion
- 14 Dec 2027 (estimated)
- First posted
- 21 Jan 2011 (estimated)
- 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 purpose of this study is to collect DNA samples from patients undergoing routine care at the University of Chicago. These samples will be tested for differences in genes that may suggest greater risk of side effects or chance of increased benefit from certain medications. The results will be made available to the patient's treating physician and the researchers will track whether or not this information is used in routine health care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Patients | – | –Adults receiving health care at the University of Chicago Medical Center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults receiving ongoing routine medical care and regularly using at least 1 (but no more than 6) prescription medications at the time of enrollment.
Key inclusion criteria (11 listed)
- Receiving ongoing, out-patient care at the University of Chicago Medical Center under the routine care of a physician participating in this trial
- Life expectancy of at least 3 years
- Must be 18 years or older
- Must be taking at least 1 (but not more than 6) prescription medications at the time of enrollment OR be 65 years or older OR be reasonably expected to require the use of a prescription medication within the next 5 years
- Patients with certain diseases, or likely to receive or be receiving certain drugs, will be targeted particularly for enrollment in order to enrich the study for patients likely to have pharmacogenetically relevant interactions, including, but not limited to:
Key exclusion criteria (3 listed)
- Patients with acute or chronic disease which could be reasonably expected to result in the patient's death within the next 3 years.
- Patients who have undergone, or are being actively considered for, liver or kidney transplantation.
- Inability to understand and give informed consent to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of incorporating pharmacogenomic testing into routine medical care
Time frame: 5 years
1 secondary outcome
Find out whether availability of pharmacogenomic information impacts drug decision making in the health care setting
Time frame: 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 Mar 2026.
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, MD 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?
An observational study of Patients Undergoing Routine Health Care and Heart Diseases, 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 11 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: looking for participants now, as of the sponsor's last update on 4 Mar 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 1200 Patients Project Study Team ((773) 834-1759, cpt1200@uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of incorporating pharmacogenomic testing into routine medical care (time frame: 5 years). 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 Mar 2026.