ClinicalTrials.gg
RecruitingNCT01280825Updated Mar 4, 2026

The 1200 Patients Project: Studying the Implementation of Clinical Pharmacogenomic Testing

An observational study in Patients Undergoing Routine Health Care, Heart Diseases and Inflammatory Bowel Diseases, sponsored by University of Chicago. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-04.

Sponsored by University of Chicago · Observational

From the registry’s dates

  • Started Jan 2011; still recruiting 15 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,200
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Patients Undergoing Routine Health Care
  • Heart Diseases
  • Inflammatory Bowel Diseases
  • Autoimmune Disease
  • Inflammatory Disease
  • Blood Coagulation Disorders
  • Hepatitis C
  • Non-Metastatic Neoplasm
03

In context

Heart Diseases

2,135 studies on the registry are indexed under Heart Diseases; 252 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 350 across 592 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

University of Chicago is the lead sponsor of 924 studies on the registry; 185 are open to participants now.

Of its 103 completed or terminated interventional studies of FDA-regulated products, 72 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Receiving ongoing, out-patient care at the University of Chicago Medical Center under the routine care of a physician participating in this trial
  • 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
    • Patients with inflammatory bowel diseases
    • Patients with systemic or inflammatory diseases
    • Patients requiring long-term oral anticoagulation
    • Patients with
    • Patients with non- cancer

Exclusion criteria

Exclusion Criteria:

  • 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 to participate.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,200 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Adult Patients

    Adults receiving health care at the University of Chicago Medical Center.

06

What researchers measure

Primary outcomes

  1. Feasibility of incorporating pharmacogenomic testing into routine medical care

    Time frame: 5 years

Secondary outcomes

  1. Find out whether availability of pharmacogenomic information impacts drug decision making in the health care setting

    Time frame: 5 years

Other outcomes

  1. To determine whether access to pharmacogenomic information improves satisfaction with care.

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2011 (actual). Primary completion is estimated for Nov 2027, 202 months after the start.

Of 184 non-industry observational studies under Heart Diseases, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 118. This study's planned 202 months is above that.

Counting every sponsor, half of 238 studies reached it within 45 months; a quarter within 18 and three quarters within 95.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 19, 2011
First posted
Jan 21, 2011
StartActual
Jan 14, 2011
Primary completionEst.
Nov 14, 2027
CompletionEst.
Dec 14, 2027
Last update
Mar 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01280825
Responsible party
Sponsor
First posted
Jan 21, 2011
Start date
Jan 14, 2011
Primary completion
Nov 14, 2027 (estimated)
Completion
Dec 14, 2027 (estimated)
Last update
Mar 4, 2026

Study contacts

1200 Patients Project Study Team
Contact
cpt1200@uchicago.edu
(773) 834-1759
Cancer Clinical Trials Office
Contact
cancerclinicaltrials@bsd.uchicago.edu
1-855-702-8222
Peter H O'Donnell, MD
principal investigator · University of Chicago

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion