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NCT Number: NCT06923618

Cancer of the Lung And SeneScencE - Prospective Cohort 1

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).

Recruiting

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henri Mondor Hospital

Créteil, Île-de-France Region, 94000, France

Location status: Recruiting

Location contact

Florence CANOUÏ-POITRINE, PhD

CONTACT

[email protected]

01 49 81 36 74 ext. +33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

blood samples

Biological

Blood samples (5 ml) during surgery or within 3 days before.

Primary outcomes

  1. Unplanned hospitalizations within 12 months

    Time frame: 12 months post surgery

    Number of unplanned hospitalizations within 12 months

Secondary outcomes

  1. Mortality (all-cause) and cause-specific

    Time frame: Month 12 and Month 60 post surgery

    Number of death (all-cause) and cause-specific at Month12 and Month 60

  2. Surgical Complications

    Time frame: Month 3 and Month 6 post surgery

    Scores on the Clavien-Dindo Scale at Month 3 and Month 6

  3. Major Toxicities

    Time frame: Month 3 and Month 6 post surgery

    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.

  4. Quality of Life Core 30

    Time frame: Month 6 and Month 12 post surgery.

    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.

  5. Quality of Life Lung Cancer 13

    Time frame: Month 6 and Month 12 post surgery

    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.

  6. Quality of Life Elderly 14

    Time frame: Month 6 and Month 12 post surgery

    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.

  7. Disease-free survival

    Time frame: Month 3, Month 12 and Month 60 post surgery

    Disease-free survival on imaging (CT scan) at Month 3, Month 6, Month 12 and Month 60

  8. Geriatric Parameters G-CODE

    Time frame: Month 3 and Month 6 post surgery

    Score on Geriatric-COre Data sEt (G-CODE) (0-17) at Month 3 and Month 6. A higher score means better outcome.

  9. Geriatric Parameters Hand grip

    Time frame: Month 3 and Month 6 post surgery

    Scores on Hand grip (kg) at Month 3 and Month 6. A higher score means better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Adèle BELLINO, Project advisor

CONTACT

[email protected]

01 71 76 07 57 ext. +33

Florence CANOUÏ-POITRINE, PhD

CONTACT

[email protected]

01 49 81 36 74 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • ARC Foundation and Inserm
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Identification of Aging Biomarkers for Better Tailoring of Cancer Treatment in Older Patients With Lung Cancer: a Multicenter Clinico-biological Cohort Study

Acronym: CLASSE-P1

Important dates

Study start
2025
Primary completion
2028
Study completion
2032
First posted
Apr 11, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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