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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCLC | Diagnosis of SCLC within 1 year of enrollment |
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| Measure | Description | Time Frame |
|---|---|---|
| Suspicious LEMS | Incidence of clinically suspicious LEMS diagnosis | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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United States
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Allison M Harper, PharmD | Contact | 704-996-6579 | aharper@alcmi.org |
| Name | Affiliation | Role |
|---|---|---|
| Jacob Sands, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Gilbert Youssef, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 12, 2025 | Jul 11, 2025 |
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| Prot_000.pdf |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D015624 | Lambert-Eaton Myasthenic Syndrome |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009157 | Myasthenia Gravis |
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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