Prospective Multicentre Study for the Application of Telo... | NCT07465848

Studies
Prospective Multicentre Study for the Application of Telomere Measurement Technology as a Tool for Lung Cancer Diagnosis

NCT07465848

Sponsor

Grupo Español de Investigación en Diagnóstico y Tratamiento Hipertemprano de Enfermedades (GeDiTPhe)

Status

Recruiting

Last Update Posted

Mar 12, 2026Actual

Enrollment

1,200Estimated

Phase

Not Applicable

Conditions

Lung Cancer (Diagnosis)
Health Adult Subjects
Patient

Interventions

Blood sample collection for telomere biomarker analysis
Telomere biomarker analysis

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 8, 2025Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Dec 30, 2025

First Submission Date that Met QC Criteria

Mar 9, 2026

First Posted Date

Mar 12, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2026

Last Update Posted Date

Mar 12, 2026Actual

Name	Class
Life Length SL	INDUSTRY
Apices Soluciones S.L.	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Case Group	Other		Diagnostic Test: Blood sample collection for telomere biomarker analysis Diagnostic Test: Telomere biomarker analysis
Control Group	Other	Cohort A (High Risk Control) and Cohort B (Low Risk Control)	Diagnostic Test: Blood sample collection for telomere biomarker analysis Diagnostic Test: Telomere biomarker analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sample collection for telomere biomarker analysis	Diagnostic Test	Peripheral blood samples will be collected to measure telomere-related biomarkers that will be used for the development of a predictive algorithm.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the risk of developing lung cancer, expressed as a percentage, in order to assist doctors in the diagnosis of lung cancer.		At study enrollment

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the performance characteristics of the predictive algorithm, which combines clinical parameters and telomeric variables, in a cohort of cases and controls.	To determine the algorithm's ability to detect lung cancer by analysing its sensitivity, specificity, positive and negative predictive values, and overall accuracy.	At study enrollment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Case Group:

Person aged 45 years or older at the time of signing the consent form.
Person with a current anatomopathologically confirmed diagnosis of small-cell or non-small cell lung cancer.
Not having received any oncological treatment prior to sample collection (surgery, radiotherapy, or systemic treatment with chemotherapy or immunotherapy).

Control Group:

Cohort A (High risk controls):

Person aged 45 years or older at the time of signing the consent form.
High risk of lung cancer, defined as having a smoking history of at least 20 pack-year and currently smoking or having quit within the past 15 years.
No diagnosis or suspicion of lung cancer. Asymptomatic individuals who have undergone a chest computed tomography (CT) scan for lung cancer screening within the 12 months prior to signing the informed consent and as part of routine clinical practice, with a LUNG-RADS score of 3 or lower, will be included.

Cohort B (Low-risk controls):

Person aged 45 years or older at the time of signing the consent form.
Without high risk of lung cancer according to the criteria defined in cohort A.
No diagnosis or suspicion of lung cancer.

Exclusion Criteria:

History of any malignant neoplasm, except for subjects with tumors in localized stages who have undergone radical treatment and have been disease-free for at least five years.
Patient diagnosed with lung cancer who has already started oncological treatment before sample collection.
Patient who has undergone a biopsy or any invasive procedure or minor surgery less than 48 hours ago.
Patient who has undergone major surgery less than 7 days ago.
Patient with severe chronic kidney disease, defined as a glomerular filtration rate below 15 ml/min.
Patient with severe liver disease, defined as Child-Pugh C.
Active infection, or treated less than 4 weeks ago.
Vulnerable population, for example, minors, prisoners, pregnant women, adults physically or mentally incapable of giving consent.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Antonio Cubillo, MD	Contact	917 56 79 97		acubillo@hmhospitales.com
Paloma Peinado, MD	Contact			ppeinado@hmhospitales.com

ID	Term
D008175	Lung Neoplasms
D004194	Disease

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D011677	Punctures
D013514	Surgical Procedures, Operative
D008919	Investigative Techniques