Searching for Predictive Biomarkers of Efficacy in Small Cell Lung Cancer Patients Treated With Chemotherapy-immunotherapy Combination Using Imaging Mass Cytometry (HYPE)

NCT ID: NCT06558903

Last Updated: 2024-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-24

Study Completion Date

2025-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this retrospective study is to identify predictive biomarkers of efficacy in tumor samples of small cell lung cancer patients treated with chemotherapy-immunotherapy combination using imaging mass cytometry. The main question it aims to answer is: is there any feature in the tumour microenvironment that can discriminate responders from non responders before treatment? Participants will provide consent for the collection of their clinical data and the study of their tumor samples

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Small cell lung cancer patients treated with first-line atezolizumab plus platinum-etoposide regimen with available formalin fixed paraffin embedded (FFPE) biopsies at baseline will be identified from Brest University Hospital medical records and their samples will be retrieved from Brest University Hospital Pathology Laboratory for imaging mass cytometry analyses.

Clinical data will be collected for each patient, including progression-free survival (defined as the time between treatment start and date of progression according to investigator, or death from any cause) and overall survival (defined as the time between treatment start and date of death from any cause).

For imaging mass cytometry analyses, a panel of 39 metal-tagged antibodies will be used to characterize the cell composition of lung tumors at baseline (inflammatory, tumor and stromal cells).

Statistical analyses will be performed to correlate the composition of the tumor microenvironment at baseline and the survival data.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Small Cell Lung Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with extensive or metastatic small cell lung cancer
* Patients who started a first line treatment with atezolizumab plus carboplatin and etoposide in routine practice before February 2021
* Patients with available tumor sample before treatment start
* No objection from living patients

Exclusion Criteria

* Patients who started first line treatment with atezolizumab plus carboplatin and etoposide in routine practice after February 2021
* Patients having received immunotherapy in a clinical trial
* Patients with auto-immune disorder
* Patients under legal protection (guardianship, curatorship)
* Patients refusing to participate to the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Margaux Geier, MD

Role: STUDY_DIRECTOR

Department of Medical Oncology, Brest University Hospital

Pierre Le Noac'h, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Oncology, Brest University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU de Brest

Brest, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

29BRC21.0110 - HYPE

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.