Neoplasms (Cancer / Tumors)WARNINGNCT07704307
Optimising the Cancer Management of Older Patients by Early and Specific Geriatric Interventions.
A study testing WARNING Pack in people with Neoplasms (Cancer / Tumors) and Geriatric Oncology, run by Poitiers University Hospital.
Trial summary
The WARNING project proposes a new care organisation for older patients with cancer. The aim is to optimise management in daycare with early detection signs of geriatric syndromes and specific interventions. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Neoplasms (Cancer / Tumors), Geriatric Oncology
- What is being tested?
- WARNING Pack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,010 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Jan 2031
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged ≥75 years.
- Patients with confirmed solid cancer or haematological malignancy, regardless of
- the site of the tumour (single or multiple), - the duration of the disease, or - the treatment modality (adjuvant, neoadjuvant, locally advanced, palliative metastatic).
- Patients starting a first line of systemic treatment or a new line of treatment after a break of at least six months.
- Patients treated in a daycare hospital.
- Persons belonging to or benefiting from a social security scheme.
- Free and informed consent after receiving appropriate information.
Who cannot join
- Patients under legal protection (guardianship, curatorship).
- Persons with enhanced protection, i.e. persons deprived of their liberty by a judicial or administrative decision, persons in a health or social care institution, persons under legal protection and patients in emergency situations.
About this study
Official title: Optimization of Care in Older Patients With Cancer Undergoing Treatment in Day Care Unit, Through a Specific Management Based on Early Geriatric Warning Signs: a Multicenter Randomized Trial.
The WARNING project proposes a new care organisation for older patients with cancer. The aim is to optimise management in daycare with early detection signs of geriatric syndromes and specific interventions. This prevention package, called the 'WARNING Pack', includes a specific multimodal geriatric management guide for the oncologist (physician form), based on patient-reported early geriatric warning signs (patient form). Primary outcome is to reduce the risk of deterioration in global quality of life at 6 months during treatment and to prevent the onset of geriatric syndromes.
- Conditions
- Neoplasms (Cancer / Tumors), Geriatric Oncology
- Being tested
- WARNING Pack
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WARNING PackOther
This prevention package, called the 'WARNING Pack', includes a specific multimodal geriatric management guide for the oncologist (physician form), based on patient-reported early geriatric warning signs (patient form).
| Study group | Role | What they receive |
|---|---|---|
| the experimental group, the WARNING pack | Experimental | the WARNING pack + routine care Receives: Other: WARNING Pack |
| Standard group | No intervention | routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with unchanged or improved global quality of life between M0 and M6.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionJul 2030 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms (Cancer / Tumors)Studies of the same condition, open and under way.
- More trials run by Poitiers 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,010 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704307
- Sponsor's protocol ID
- 2026-A01098-43
- Acronym
- WARNING
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Care in Older Patients With Cancer Undergoing Treatment in Day Care Unit, Through a Specific Management Based on Early Geriatric Warning Signs: a Multicenter Randomized Trial.
- ClinicalTrials.gov ID
- NCT07704307
- Acronym / sponsor ID
- WARNING / 2026-A01098-43
- Conditions
- Neoplasms (Cancer / Tumors), Geriatric Oncology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,010 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 15 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 WARNING project proposes a new care organisation for older patients with cancer. The aim is to optimise management in daycare with early detection signs of geriatric syndromes and specific interventions. This prevention package, called the 'WARNING Pack', includes a specific multimodal geriatric management guide for the oncologist (physician form), based on patient-reported early geriatric warning signs (patient form). Primary outcome is to reduce the risk of deterioration in global quality of life at 6 months during treatment and to prevent the onset of geriatric syndromes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the experimental group, the WARNING pack | Experimental | Other: WARNING Packthe WARNING pack + routine care |
| Standard group | No intervention | –routine care |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Patients aged ≥75 years.
- Patients with confirmed solid cancer or haematological malignancy, regardless of
- the site of the tumour (single or multiple), - the duration of the disease, or - the treatment modality (adjuvant, neoadjuvant, locally advanced, palliative metastatic).
- Patients starting a first line of systemic treatment or a new line of treatment after a break of at least six months.
- Patients treated in a daycare hospital.
Key exclusion criteria (2 listed)
- Patients under legal protection (guardianship, curatorship).
- Persons with enhanced protection, i.e. persons deprived of their liberty by a judicial or administrative decision, persons in a health or social care institution, persons under legal protection and patients in emergency situations.
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 |
|---|---|---|
| WARNING PackThis prevention package, called the 'WARNING Pack', includes a specific multimodal geriatric management guide for the oncologist (physician form), based on patient-reported early geriatric warning signs (patient form). | Other | the experimental group, the WARNING pack |
Primary outcome
Proportion of patients with unchanged or improved global quality of life between M0 and M6.
Time frame: 6 month
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 22 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing WARNING Pack in people with Neoplasms (Cancer / Tumors) and Geriatric Oncology, run by Poitiers University Hospital.
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 7 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: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with unchanged or improved global quality of life between M0 and M6. (time frame: 6 month). 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 22 Jul 2026.