Epigenomic Profiling of Circulating Cell-Free DNA (cfDNA) to Characterize the Dynamic Evolution of Molecular Subtypes in Extensive-Stage Small Cell Lung Cancer During First-Line Chemoimmunotherapy

NCT07670442 | Not Yet Recruiting

• 1 other identifier: APHP260603
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The EPICIRC SCLC project aims to improve our understanding and treatment of extensive-stage small cell lung cancer (ES SCLC), the most aggressive form of lung cancer that accounts for 15% of all cases. Despite current treatments, which combine chemotherapy with immunotherapy, the outlook for patients remains poor, with an average survival of just 12 months. Recent research has shown that this cancer can be classified into four subtypes, which respond differently to anti-cancer treatments. However, these subtypes may change over time, particularly during chemotherapy, which could explain why many patients eventually become resistant to treatment. Understanding how these subtypes evolve could pave the way for better treatment strategies, but it has been difficult to study these changes because new tumor samples are rarely collected after a patient is diagnosed. The EPICIRC SCLC project tackles this challenge by using liquid biopsies, a minimally invasive technique that analyzes circulating free DNA (cfDNA) found in patients blood. This approach allows to monitor changes in the tumor's molecular profile over time without needing additional tissue samples. By collecting and analyzing blood samples from patients at three key points-before treatment, after four cycles of chemo-immunotherapy, and at disease progression-the project aims to track the evolution of the tumor's molecular subtypes and identify patterns associated with treatment resistance. Using advanced epigenomic technologies, we will study how genes are regulated and how their activity changes during treatment. This will provide a detailed map of the tumor's molecular evolution and could uncover new targets for future therapies. In the long term, these findings would lead to more personalized treatment strategies, helping clinicians select therapies based on the specific molecular profile of each patient's cancer at different stages of their treatment.

Conditions

Small Cell Lung Cancer

Keywords

liquid biopsy; cell free DNA; Smal Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• To evaluate the evolution of the four molecular subtypes (SCLC-A, SCLC-N, SCLC-P, and SCLC-I) during first-line chemo-immunotherapy using epigenomic analyses performed on plasma samples from patients

  From initial diagnosis to treatment resistance (disease progression), with a median time of 12 months and a maximum follow-up of 24 months after study inclusion.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with SCLC

You may qualify if:

• Histologically or cytologically confirmed SCLC
• Indication for first-line systemic anti-tumor treatment with chemo-immunotherapy as decided in a multidisciplinary tumor board.
• Patient's ability to comply with the required study follow-up.
• Age ≥ 18 years.
• Patient affiliated with a social security scheme.
• Patient managed in the Thoracic Oncology department of Cochin Hospital or HEGP.
• Patient able to understand the participant information sheet.

You may not qualify if:

• Expressed refusal at the time of receiving the information sheet.
• Person not proficient in the French language.
• Person deprived of liberty or under legal protection (including guardianship or curatorship).
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Simon Garinet

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saada Diab

CONTACT

+33156095982; saada.diab@aphp.fr

Simon Garinet

CONTACT

+33156095980

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 26, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share