Pelvic FractureCOSMOS-INCT07740239
A COhort Study on Factors Leading to Vulnerability in Adult Patients With Serious Medical cOnditionS: the COSMOS-I Trial
An observational study of Pelvic Fracture and Prostate Cancer, run by Tampere University Hospital at 1 site in Finland.
Trial summary
The objective of this prospective multicentre study that recruits altogether 1500 older patients from the university hospitals of Tampere, Kuopio, and Oulu is to explore the clinical significance and detection of causes of generalized vulnerability. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Pelvic Fracture, Prostate Cancer, Lung Cancer
- What is being tested?
- Test set to determine vulnerability
- How many people
- 2,050 participants
- Where
- 1 siteFinland
- Study dates
- 13 Nov 2024to 30 Dec 2030
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: * Patients with local, locally advanced and metastatic prostate cancer (n=300) * Patients with locally advanced and metastatic lung cancer (n=300) * Patients with brain metastasis (n=300) * Patients with chronic subdural hematoma (n=300) * Patients receiving high-dose chemotherapy and stem cell transplantion
Who may be able to join
- Suspected or diagnosed disease
- ≥60 years old patients, except for patients receiving high-dose chemotherapy and stem cell transplantion who need to be ≥18 years old
- Cross-sectional imaging maximum 45 days prior to consenting or before the next treatment line
- Patients with cancer (other than patients with prostate cancer treated with hormonal treatment before radiation treatment): study procedures (excluding image analyses) must have been carried out maximum 1 month prior to the start of a new treatment line
- Patients with prostate cancers receiving hormonal treatment before radiation treatment): study procedures (excluding image analyses) must be carried out maximum 3 months after the start of hormonal treatment
- Patients with other conditions: study procedures (excluding image analyses) must have been carried out maximum 4 days after the start of the hospitalization
Who cannot join
- Not willing or unable to give written consent
- Patient not deemed suitable for the study by the researcher approaching the patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Tampere University Hospital
Tampere
Otso Arponen, 0504106170 ext. +358, otso.arponen@tuni.fi
About this study
The objective of this prospective multicentre study that recruits altogether 1500 older patients from the university hospitals of Tampere, Kuopio, and Oulu is to explore the clinical significance and detection of causes of generalized vulnerability. The objectives are:
O1 - Establish the prevalence of causes of generalized vulnerability among patients diagnosed with severe yet non-malignant diseases and local/locally advanced and advanced cancers, O2 - Study how causes of generalized vulnerability affect the time between the diagnosis and the adoption of a fully palliative treatment line, overall survival, and patient-reported quality of life in older adults severe diseases, and O3 - Evaluate how screening tools commonly used in patients without cancer perform in screening for causes of vulnerability in older adults with cancer
- Conditions
- Pelvic Fracture, Prostate Cancer, Lung Cancer, Brain Metastasis, Chronic Subdural Hematoma
- Being tested
- Test set to determine vulnerability
- Medical subject headings
- Hip Fractures, Prostatic Neoplasms, Lung Neoplasms, Brain Neoplasms, Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test set to determine vulnerabilityOther
This is a prospective observational study.
| Study group | Role | What they receive |
|---|---|---|
| Prostate Cancer | Not described Receives: Other: Test set to determine vulnerability | |
| Lung Cancer | Not described Receives: Other: Test set to determine vulnerability | |
| Pelvic Fracture | Not described Receives: Other: Test set to determine vulnerability | |
| Chronic Subdural Hematoma | Not described Receives: Other: Test set to determine vulnerability | |
| Brain Metastasis | Not described Receives: Other: Test set to determine vulnerability | |
| High-dose Chemotherapy and Stem Cell Transplant | Not described Receives: Other: Test set to determine vulnerability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detected cause of vulnerability
Measured: Around the time of study procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start13 Nov 2024
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic FractureStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Otso Arponen, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740239
- Sponsor's protocol ID
- R24006
- Acronym
- COSMOS-I
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 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 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A COhort Study on Factors Leading to Vulnerability in Adult Patients With Serious Medical cOnditionS: the COSMOS-I Trial
- ClinicalTrials.gov ID
- NCT07740239
- Acronym / sponsor ID
- COSMOS-I / R24006
- Conditions
- Pelvic Fracture, Prostate Cancer, Lung Cancer, Brain Metastasis, Chronic Subdural Hematoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,050 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 31 Jul 2026 (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 objective of this prospective multicentre study that recruits altogether 1500 older patients from the university hospitals of Tampere, Kuopio, and Oulu is to explore the clinical significance and detection of causes of generalized vulnerability. The objectives are:
O1 - Establish the prevalence of causes of generalized vulnerability among patients diagnosed with severe yet non-malignant diseases and local/locally advanced and advanced cancers, O2 - Study how causes of generalized vulnerability affect the time between the diagnosis and the adoption of a fully palliative treatment line, overall survival, and patient-reported quality of life in older adults severe diseases, and O3 - Evaluate how screening tools commonly used in patients without cancer perform in screening for causes of vulnerability in older adults with cancer
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Prostate Cancer | – | Other: Test set to determine vulnerability |
| Lung Cancer | – | Other: Test set to determine vulnerability |
| Pelvic Fracture | – | Other: Test set to determine vulnerability |
| Chronic Subdural Hematoma | – | Other: Test set to determine vulnerability |
| Brain Metastasis | – | Other: Test set to determine vulnerability |
| High-dose Chemotherapy and Stem Cell Transplant | – | Other: Test set to determine vulnerability |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Patients with local, locally advanced and metastatic prostate cancer (n=300) * Patients with locally advanced and metastatic lung cancer (n=300) * Patients with brain metastasis (n=300) * Patients with chronic subdural hematoma (n=300) * Patients receiving high-dose chemotherapy and stem cell transplantion
Key inclusion criteria (6 listed)
- Suspected or diagnosed disease
- ≥60 years old patients, except for patients receiving high-dose chemotherapy and stem cell transplantion who need to be ≥18 years old
- Cross-sectional imaging maximum 45 days prior to consenting or before the next treatment line
- Patients with cancer (other than patients with prostate cancer treated with hormonal treatment before radiation treatment): study procedures (excluding image analyses) must have been carried out maximum 1 month prior to the start of a new treatment line
- Patients with prostate cancers receiving hormonal treatment before radiation treatment): study procedures (excluding image analyses) must be carried out maximum 3 months after the start of hormonal treatment
Key exclusion criteria (2 listed)
- Not willing or unable to give written consent
- Patient not deemed suitable for the study by the researcher approaching the patient
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 |
|---|---|---|
| Test set to determine vulnerabilityThis is a prospective observational study. | Other | Brain Metastasis, Chronic Subdural Hematoma, High-dose Chemotherapy and Stem Cell Transplant, Lung Cancer, Pelvic Fracture, Prostate Cancer |
Primary outcome
Detected cause of vulnerability
Time frame: Around the time of study procedure
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 31 Jul 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 Pelvic Fracture and Prostate Cancer, run by Tampere University Hospital at 1 site in Finland.
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 6 inclusion and 2 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 31 Jul 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 Finland. 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 Otso Arponen, Adjunct professor, MD (504106170 ext. +358, otso.arponen@tuni.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detected cause of vulnerability (time frame: Around the time of study procedure). 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 31 Jul 2026.