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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07075627
Enrollment
0
Registered
2025-07-20
Start date
2025-09-01
Completion date
2026-12-01
Last updated
2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Detailed description

This is a multi-center observational study in subjects with a diagnosis of small cell lung cancer. All eligible subjects enrolled will undergo a brief, symptom directed neurological evaluation and VGCC antibody testing (to be performed at a participating Quest laboratory). The results (positive/negative) of VGCC antibody testing will be documented as well as the receptor type P, Q or N. These tests will be repeated quarterly (Q3 months) for the duration of the study. If at any visit the subject is found to be BOTH neurologically suggestive of having LEMS and the VGCC Ab test is positive, then the subject is considered to be Clinically Suspicious of having LEMS. At any visit if a subject meets the criteria of Clinically Suspicious of LEMS. the end of study visit will be completed. Once the End of study visit is completed no further treatment information will be collected.

Interventions

None listed

Sponsors

Addario Lung Cancer Medical Institute
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Adult men or women meeting Age of Majority (AOM) at the time of consent 2. Provide voluntary consent to participate in this study, documented via a signed informed Consent Form (ICF) 3. Any diagnosis of SCLC 4. Willing to provide clinical and medical information related to his/her cancer diagnoses to the study team as required 5. Willing to comply with the requirements of the study

Exclusion criteria

1. Has been diagnosed with non-tumor Lamber-Eaton Myasthenic syndrome (LEMS) \> 1 year prior to the SCLC diagnosis. 2. Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements

Design outcomes

Primary

MeasureTime frameDescription
Suspicious LEMS1 yearIncidence of clinically suspicious LEMS diagnosis

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJacob Sands, MD

Dana-Farber Cancer Institute

PRINCIPAL_INVESTIGATORGilbert Youssef, MD

Dana-Farber Cancer Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026