A Study to Evaluate the Incidence of Clinically Suspicious Lambert-Eaton Myasthenic Syndrome (LEMS) in Subjects Diagnosed With Small Cell Lung Cancer (SCLC)

NCT07075627 | Not Yet Recruiting

• 1 other identifier: ALCMI-024
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center observational study in subjects with a diagnosis of small cell lung cancer. Screening and/or medical record review for symptoms associated with Lambert Eaton Myasthenic Syndrome (LEMS) will be conducted.

Conditions

Small Cell Lung Cancer ( SCLC ); Lambert Eaton Myasthenic Syndrome (LEMS)

Keywords

SCLC; LEMS; small cell lung cancer; lambert eaton myasthenic syndrome

Outcome Measures

Primary Outcomes (1)

• Suspicious LEMS

  Incidence of clinically suspicious LEMS diagnosis

  1 year

Study Arms (1)

SCLC

Diagnosis of SCLC within 1 year of enrollment

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

United States

You may qualify if:

• Adult men or women meeting Age of Majority (AOM) at the time of consent
• Provide voluntary consent to participate in this study, documented via a signed informed Consent Form (ICF)
• Any diagnosis of SCLC
• Willing to provide clinical and medical information related to his/her cancer diagnoses to the study team as required
• Willing to comply with the requirements of the study

You may not qualify if:

• Has been diagnosed with non-tumor Lamber-Eaton Myasthenic syndrome (LEMS) \> 1 year prior to the SCLC diagnosis.
• Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements

Sponsors & Collaborators

• Addario Lung Cancer Medical Institute: lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Lambert-Eaton Myasthenic Syndrome

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Myasthenia Gravis; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jacob Sands, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

• Gilbert Youssef, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison M Harper, PharmD

CONTACT

704-996-6579; aharper@alcmi.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 20, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

US (1)