Non-Small Cell Lung CancerCLASSE-P1NCT06923618
Cancer of the Lung And SeneScencE - Prospective Cohort 1
A study testing Blood samples in people with Non-Small Cell Lung Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main objective is to identify and assess the predictive value of ageing and senescence biomarkers (methylome, telomeres, inflammageing) and senescent cells in tissues to improve prognosis assessment older patients with locally or locally-advanced Non-Small Cell Lung Cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Blood samples
- How many people
- 385 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jul 2025to Jul 2032
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients 70 years and over
- Local or locally advanced (Clinic stage I-IIIA) NSCLC (clinically (or radiologically) suspected or histologically proven)
- Surgical Curative Intent
- Signed informed Consent (or signed by the curator or tutorship)
- Affiliated to social security administrative care service
Who cannot join
- Synchronous cancer (histologically proven or strongly suspected non-lung cancer in the 6 months prior to inclusion (excluding basal cell cancer and prostate cancer with local treatment (radiotherapy or surgery) or active surveillance without systemic treatment (chemotherapy, hormone therapy)).
- Subject deprived of liberty by judicial or administrative decision or patient under guardianship
- Subject unable to understand the purpose and conditions of the study and unable to give consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Henri Mondor Hospital
Créteil, Île-de-France Region, 94000
Florence CANOUÏ-POITRINE, PhD, 01 49 81 36 74 ext. +33, florence.canoui-poitrine@aphp.fr
About this study
Official title: Identification of Aging Biomarkers for Better Tailoring of Cancer Treatment in Older Patients With Lung Cancer: a Multicenter Clinico-biological Cohort Study
The main objective is to identify and assess the predictive value of ageing and senescence biomarkers (methylome, telomeres, inflammageing) and senescent cells in tissues to improve prognosis assessment older patients with locally or locally-advanced Non-Small Cell Lung Cancer (NSCLC).
Read the detailed description
Geriatric assessment allows oncologists to stratify older cancer patients into risk categories (fit, vulnerable and frail) but few patients benefit from it. Yet, they do not evaluate physiological reserves when oncologists are in dire need of quantitative tools accounting for age-related changes. This decade has witnessed the remarkable power of multiple tools (epigenetics, telomere integrity, cellular and immunosenescence) to estimate an individual's age. These tools hold the potential for routine implementation in the clinic and to be combined with existing tests. The main objective is to identify and assess the predictive value of ageing and senescence biomarkers (methylome, telomeres, inflammageing) and senescent cells in tissues to improve to improve prognosis assessment in older patients with locally or locally-advanced Non-Small Cell Lung Cancer (NSCLC).
The ambition of this study is to refine the prognosis assessment and optimize decision-making process, better anticipate adverse-events and unplanned hospitalization and better manage and care high risk patients of early death, unplanned hospitalization, major complication or toxicities and altered quality of life.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Blood samples
- Keywords
- Non-Small Cell Lung Cancer, Aging biomarkers
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
Blood samples (5 ml) during surgery or within 3 days before.
What is being measured
The primary outcome is the main question the study is designed to answer.
Unplanned hospitalizations within 12 months
Number of unplanned hospitalizations within 12 months
Measured: 12 months post surgery
Secondary outcomes (9)
Mortality (all-cause) and cause-specific
Number of death (all-cause) and cause-specific at Month12 and Month 60
Measured: Month 12 and Month 60 post surgery
Surgical Complications
Scores on the Clavien-Dindo Scale at Month 3 and Month 6
Measured: Month 3 and Month 6 post surgery
Major Toxicities
Scores on the NCI-PRO-CTCA (National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) scale (Lickert scale with 5 levels/item) at Month 3 . A higher score means worse outcome.
Measured: Month 3 and Month 6 post surgery
Quality of Life Core 30
Scores on the Quality of Life (QLQ) patients self-questionnaires Core 30 (0-100 points) at Month 6 and Month 12. A higher score means worse outcome.
Measured: Month 6 and Month 12 post surgery.
Quality of Life Lung Cancer 13
Scores on the Quality of Life (QLQ) patients self-questionnaires Lung Cancer 13 (0-100 points) at Month 6 and Month 12. A higher score means worse outcome.
Measured: Month 6 and Month 12 post surgery
Quality of Life Elderly 14
Scores on the Quality of Life (QLQ) patients self-questionnaires Elderly 14 (0-100 points) at Month 6 and Month 12. A higher score means worse outcome.
Measured: Month 6 and Month 12 post surgery
Disease-free survival
Disease-free survival on imaging (CT scan) at Month 3, Month 6, Month 12 and Month 60
Measured: Month 3, Month 12 and Month 60 post surgery
Geriatric Parameters G-CODE
Score on Geriatric-COre Data sEt (G-CODE) (0-17) at Month 3 and Month 6. A higher score means better outcome.
Measured: Month 3 and Month 6 post surgery
Geriatric Parameters Hand grip
Scores on Hand grip (kg) at Month 3 and Month 6. A higher score means better outcome.
Measured: Month 3 and Month 6 post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start9 Jul 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- ARC Foundation and Inserm, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Florence CANOUÏ-POITRINE, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923618
- Sponsor's protocol ID
- APHP241246
- Other IDs
- ID-RCB Number
- Acronym
- CLASSE-P1
- Status last verified
- Sep 2025
- First submitted
- 17 Feb 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Aging Biomarkers for Better Tailoring of Cancer Treatment in Older Patients With Lung Cancer: a Multicenter Clinico-biological Cohort Study
- ClinicalTrials.gov ID
- NCT06923618
- Acronym / sponsor ID
- CLASSE-P1 / APHP241246
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, Aging biomarkers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- ARC Foundation and Inserm, URC-CIC Paris Descartes Necker Cochin
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2032 (estimated)
- First posted
- 11 Apr 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.
The main objective is to identify and assess the predictive value of ageing and senescence biomarkers (methylome, telomeres, inflammageing) and senescent cells in tissues to improve prognosis assessment older patients with locally or locally-advanced Non-Small Cell Lung Cancer (NSCLC).
Detailed description
Geriatric assessment allows oncologists to stratify older cancer patients into risk categories (fit, vulnerable and frail) but few patients benefit from it. Yet, they do not evaluate physiological reserves when oncologists are in dire need of quantitative tools accounting for age-related changes. This decade has witnessed the remarkable power of multiple tools (epigenetics, telomere integrity, cellular and immunosenescence) to estimate an individual's age. These tools hold the potential for routine implementation in the clinic and to be combined with existing tests. The main objective is to identify and assess the predictive value of ageing and senescence biomarkers (methylome, telomeres, inflammageing) and senescent cells in tissues to improve to improve prognosis assessment in older patients with locally or locally-advanced Non-Small Cell Lung Cancer (NSCLC).
The ambition of this study is to refine the prognosis assessment and optimize decision-making process, better anticipate adverse-events and unplanned hospitalization and better manage and care high risk patients of early death, unplanned hospitalization, major complication or toxicities and altered quality of life.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients 70 years and over
- Local or locally advanced (Clinic stage I-IIIA) NSCLC (clinically (or radiologically) suspected or histologically proven)
- Surgical Curative Intent
- Signed informed Consent (or signed by the curator or tutorship)
- Affiliated to social security administrative care service
Key exclusion criteria (3 listed)
- Synchronous cancer (histologically proven or strongly suspected non-lung cancer in the 6 months prior to inclusion (excluding basal cell cancer and prostate cancer with local treatment (radiotherapy or surgery) or active surveillance without systemic treatment (chemotherapy, hormone therapy)).
- Subject deprived of liberty by judicial or administrative decision or patient under guardianship
- Subject unable to understand the purpose and conditions of the study and unable to give consent
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 |
|---|---|---|
| Blood samplesBlood samples (5 ml) during surgery or within 3 days before. | Biological | – |
Primary outcome
Unplanned hospitalizations within 12 months
Time frame: 12 months post surgery
Number of unplanned hospitalizations within 12 months
9 secondary outcomes
Mortality (all-cause) and cause-specific
Time frame: Month 12 and Month 60 post surgery
Surgical Complications
Time frame: Month 3 and Month 6 post surgery
Major Toxicities
Time frame: Month 3 and Month 6 post surgery
Quality of Life Core 30
Time frame: Month 6 and Month 12 post surgery.
Quality of Life Lung Cancer 13
Time frame: Month 6 and Month 12 post surgery
Quality of Life Elderly 14
Time frame: Month 6 and Month 12 post surgery
Disease-free survival
Time frame: Month 3, Month 12 and Month 60 post surgery
Geriatric Parameters G-CODE
Time frame: Month 3 and Month 6 post surgery
Geriatric Parameters Hand grip
Time frame: Month 3 and Month 6 post surgery
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 15 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Florence CANOUÏ-POITRINE, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with Non-Small Cell Lung Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 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 15 Dec 2025. 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 France. 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 Florence CANOUÏ-POITRINE, PhD (01 49 81 36 74 ext. +33, florence.canoui-poitrine@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unplanned hospitalizations within 12 months (time frame: 12 months post surgery). 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 15 Dec 2025.