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Small Cell Lung Cancer Community Engagement to Eliminate Research Discepancies

NCT ID: NCT06486428

Last Updated: 2025-08-01

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

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-23

Study Completion Date

2027-06-30

Brief Summary

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This study will evaluate if a direct-to-patient, de-centralized, remote approach will improve clinical research outreach and engagement for patients with SCLC, in the context of a bio-specimen collection study. The study will also assess self-reported preferences and needs of patients with SCLC, regarding choosing and accessing novel therapies in research or standard clinical care settings and supportive gaps in this area, through an initial and 3 month follow up survey.

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Detailed Description

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This is a non-interventional, non-treatment, non-randomized, single coordinating center, study to determine the feasibility of decentralized bio-specimen collection in USA-based adult subjects with SCLC, to be conducted in conformance with Good Clinical Practices. Potential study subjects will be referred to contact staff through a dedicated study webpage form or dedicated study phone hotline at the coordinating center (ALCMI) who will handle informed consent, coordinate remote blood sample collection with study subjects, and collect medical records to confirm diagnosis and treatment history. Subjects will also be asked to complete a baseline and follow up questionnaire/survey documenting their self-report diagnosis, treatment history, factors impacting care and quality of life, and needs/preferences regarding supportive resources.

Patients who have been diagnosed with either extensive stage primary SCLC or patients diagnosed with primary NSCLC who experienced histological "transformation" with a SCLC component after initial diagnosis and subsequent treatment (transformed SCLC; tSCLC) will be invited to volunteer for this study.

Conditions

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Small-cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SCLC (primary de novo)

Blood collection, survey (baseline and Month 3)

No interventions assigned to this group

SCLC (transformed)

Blood collection, survey (baseline and Month 3)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Men or women greater than or equal to 18 years of age at the time of consent
2. Ability to read, write and communicate in English
3. Provide voluntary consent to participate in this study, documented via a signed informed Consent Form (ICF)
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
6. Diagnosis of extensive stage primary SCLC or tSCLC

Exclusion Criteria

1. Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements
2. Subjects who previously enrolled to this study

Note: Concurrent enrollment in other clinical trials is NOT exclusionary
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Addario Lung Cancer Medical Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine Lovly, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Cancer Center, Nashville, TN

Locations

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Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Alabama, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Alaska, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Arizona, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Arkansas, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, California, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Colorado, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Connecticut, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Delaware, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, District of Columbia, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Florida, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Georgia, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Hawaii, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Idaho, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Illinois, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Indiana, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Iowa, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Kansas, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Kentucky, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Louisiana, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Maine, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Maryland, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Massachusetts, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Michigan, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Minnesota, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Mississippi, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Missouri, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Montana, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Nebraska, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Nevada, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, New Hampshire, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, New Jersey, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, New Mexico, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, New York, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, North Carolina, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, North Dakota, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Ohio, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Oklahoma, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Oregon, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Pennsylvania, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Rhode Island, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, South Carolina, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, South Dakota, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Tennessee, United States

Site Status RECRUITING

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Texas, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Utah, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Vermont, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Virginia, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Washington, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, West Virginia, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Wisconsin, United States

Site Status RECRUITING

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Multiple Locations, Wyoming, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Allison Harper, PharmD

Role: CONTACT

[email protected]
833-333-7252

Facility Contacts

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USA-wide Study Website

Role: primary

[email protected]
8333337252

USA-wide Study Website

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[email protected]
8333337252

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[email protected]

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8333337252

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8333337252

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8333337252

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8333337252

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8333337252

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8333337252

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8333337252

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8333337252

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8333337252

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8333337252

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8333337252

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8333337252

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8333337252

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8333337252

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[email protected]
8333337252

USA-wide Study Website

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[email protected]
8333337252

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[email protected]

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[email protected]
8333337252

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[email protected]

USA-wide Study Website

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[email protected]
8333337252

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[email protected]

USA-wide Study Website

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[email protected]
8333337252

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[email protected]

USA-wide Study Website

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[email protected]
8333337252

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USA-wide Study Website

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[email protected]
8333337252

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USA-wide Study Website

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[email protected]
8333337252

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[email protected]

USA-wide Study Website

Role: primary

[email protected]
8333337252

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[email protected]

Other Identifiers

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ALCMI-023

Identifier Type: -

Identifier Source: org_study_id

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