Overall Survival (All-cause Mortality)NCT07224659
Exercise and Mortality in Middle-Aged and Older Adults
An observational study of Overall Survival (All-cause Mortality), run by City of Hope Medical Center at 1 site in United States.
Trial summary
This protocol is a retrospective study using the observational data of the the Prostate, Lung, Colorectal, and Ovarian (PLCO) screening trial with over 150,000 participants aged 55-74 years to conduct a target trial emulation to examine the association between self-reported exercise and all cause and cause-specific… Read more about this study
- Who is it for?
- Ages 55 to 74 years
- Conditions the study is for
- Overall Survival (All-cause Mortality)
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 19,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Dec 2026
- 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 55 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults enrolled into the PLCO screening trial
- Adults enrolled into the PLCO screening trial.
- Among participants reporting low exercise at Q0 (i.e., 0 or less than 1 day/week, with each session <15 minutes in duration), completion of an exercise survey at Q1 as part of PLCO standard trial procedures no later than 5 years after reporting non-exercising status [i.e., no exercise) at Q0.
- No evidence of any of the following absolute contraindications to exercise: uncontrolled hypertension, symptomatic valvular disease; hypertrophic cardiomyopathy; unstable angina pectoris; primary pulmonary hypertension; heart failure; severe arrhythmia; diagnosed dementia; any form of cancer other than non-melanoma, and severe infectious disease.
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
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Exercise and Mortality in Middle-Aged and Older Adults: A Target Trial Emulation
This protocol is a retrospective study using the observational data of the the Prostate, Lung, Colorectal, and Ovarian (PLCO) screening trial with over 150,000 participants aged 55-74 years to conduct a target trial emulation to examine the association between self-reported exercise and all cause and cause-specific mortality in apparently healthy, middle-aged and older adults. The PLCO includes assessments of participants' exercise level at two timepoints: at randomization into the PLCO trial (Q0) and 5-7 years after randomization into the PLCO (Q1).
- Conditions
- Overall Survival (All-cause Mortality)
- Being tested
- Control, Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
0 or less than 1 day per week, with each session, on average < 15 minutes.
ExerciseBehavioural
>/= 2 days per week of moderate or vigorous intensity, with each session, on average, >/=20 minutes in duration.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Control | 0 or less than 1 day per week, with each session, on average < 15 minutes. Receives: Behavioral: Control | |
| Arm 2 - Exercise | >/= 2 days per week of moderate or vigorous intensity, with each session, on average, >/=20 minutes in duration. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (all-cause mortality)
All-cause mortality (death from any cause) occurring within the follow-up period in the PLCO screening trial.
Measured: up to 19 years
Cause-specific mortality
Cause-specific mortality (cancer mortality, mortality from other causes) occurring within the total follow-up period in the PLCO screening trial.
Measured: up to 19 years
Secondary outcomes (1)
Cancer incidence
Cancer incidence occurring within the total follow-up period in the PLCO screening trial.
Measured: up to 19 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2025
- Study start1 Oct 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overall Survival (All-cause Mortality)Studies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- Retrospective
- Enrolment
- 19,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224659
- Sponsor's protocol ID
- 25603
- Status last verified
- Aug 2026
- First submitted
- 2 Nov 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Mortality in Middle-Aged and Older Adults: A Target Trial Emulation
- ClinicalTrials.gov ID
- NCT07224659
- Acronym / sponsor ID
- 25603
- Conditions
- Overall Survival (All-cause Mortality)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 19,000 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 5 Nov 2025 (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 protocol is a retrospective study using the observational data of the the Prostate, Lung, Colorectal, and Ovarian (PLCO) screening trial with over 150,000 participants aged 55-74 years to conduct a target trial emulation to examine the association between self-reported exercise and all cause and cause-specific mortality in apparently healthy, middle-aged and older adults. The PLCO includes assessments of participants' exercise level at two timepoints: at randomization into the PLCO trial (Q0) and 5-7 years after randomization into the PLCO (Q1).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Control | – | Behavioral: Control0 or less than 1 day per week, with each session, on average < 15 minutes. |
| Arm 2 - Exercise | – | Behavioral: Exercise>/= 2 days per week of moderate or vigorous intensity, with each session, on average, >/=20 minutes in duration. |
Who may qualify
- Ages
- 55 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults enrolled into the PLCO screening trial
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 |
|---|---|---|
| Control0 or less than 1 day per week, with each session, on average < 15 minutes. | Behavioural | Arm 1 - Control |
| Exercise>/= 2 days per week of moderate or vigorous intensity, with each session, on average, >/=20 minutes in duration. | Behavioural | Arm 2 - Exercise |
Primary outcome
Overall survival (all-cause mortality)
Time frame: up to 19 years
All-cause mortality (death from any cause) occurring within the follow-up period in the PLCO screening trial.
Cause-specific mortality
Time frame: up to 19 years
Cause-specific mortality (cancer mortality, mortality from other causes) occurring within the total follow-up period in the PLCO screening trial.
1 secondary outcome
Cancer incidence
Time frame: up to 19 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 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Overall Survival (All-cause Mortality), run by City of Hope Medical Center 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?
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: opening soon, as of the sponsor's last update on 19 Aug 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 Lee W Jones, PhD (626-218-3844, leejones@coh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (all-cause mortality) (time frame: up to 19 years). The study lists 2 primary outcomes in all. 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 19 Aug 2026.