EX VIVO DRUG RESPONSE PROFILING AND OUTCOME PREDICTION IN LUNG ADENOCARCINOMA

NCT07636252 | Recruiting

• 1 other identifier: SHEBA-18-5494-MP-CTIL
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study evaluates if ex-vivo lung cancer drug sensitivity testing results correlate with the driver mutations found by genetic sequencing and if it can predict treatment response.

Conditions

Lung Adenocarcinoma; Malignant Pleural Effusions (Mpe)

Keywords

Drug sensitivity testing, malignant pleural effusion, lung cancer

Outcome Measures

Primary Outcomes (1)

• Statistically significant correlation between patients' drug response by ex-vivo drug profiling and expected drug sensitivity according to genetic sequencing

  Ex-vivo drug sensitivity categorizes drugs as sensitive/not sensitive. Results will be compared with the expected sensitivity of drugs according to the driver mutation found be genetic sequencing. For example, in EGFR-driven lung cancer, the tumor cells are expected to be more sensitive to EGFR-targeting drugs than to ALK-targeting drugs.

  From enrollment until results of clinical genetic sequencing and drug sensitivity testing are obtained (within 3 weeks).

Secondary Outcomes (1)

• Accuracy of patients' drug response prediction by ex-vivo drug profiling

  from date of enrollment until progression (latest 24 months)

Study Arms (1)

Patients with diagnosis of a Lung adenocarcinoma with the need of pleural drainage due to MPE

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-Interventional Study, patients go through pleural drainage due to shortness of breath

Patients with diagnosis of a Lung adenocarcinoma with the need of pleural drainage due to MPE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pleural effusion with a diagnosis of a lung cancer or suspected to be diagnosed with lung cancer according to their CT imaging, who are in need for pleural effusion drainage due to shortness of breath, and are willing to donate effusion for ex-vivo drug sensitivity testing.

You may qualify if:

• Presence of pleural effusion in patient with a diagnosis of a lung cancer or suspected to be diagnosed with lung cancer according to their CT imaging, who are in need for pleural effusion drainage due to shortness of breath, and are willing to donate effusion for ex-vivo drug sensitivity testing.
• Patient's written informed consent present.
• Ability to understand the nature of the trial and the trial related procedures and to comply with them.

You may not qualify if:

• negative cytology for malignancy in the last 6 months

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 5262100, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

live tumor cells will be stored frozen in liquid nitrogen tanks

MeSH Terms

Conditions

Adenocarcinoma of Lung; Pleural Effusion, Malignant; Myeloproliferative Disorder, Chronic, with Eosinophilia; Lung Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases; Lung Diseases

Study Design

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

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 9, 2026
• Study Start: June 14, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: June 9, 2026

Record last verified: 2026-05

Locations

IL (1)