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Recruiting

NCT Number: NCT06486428

Small Cell Lung Cancer Community Engagement to Eliminate Research Discepancies

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html, Multiple Locations, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Note: Concurrent enrollment in other clinical trials is NOT exclusionary

Treatment and study plan

Primary outcomes

  1. Feasibility of conducting trial in SCLC population

    Time frame: 12 months

    Percentage of overall eligible subjects enrolled. Percentage of primary SCLC eligible subjects enrolled. Percentage of tSCLC eligible subjects enrolled. Percentage of SCLC eligible subjects enrolled compared to percentage of tSCLC eligible subjects enrolled. Percentage of primary SCLC enrolled subjects completed. Percentage of tSCLC enrolled subjects completed. Percentage of SCLC enrolled subjects completed compared to percentage of tSCLC enrolled subjects completed. Overall reasons for early termination. Reasons for early termination from trial in primary SCLC enrolled. Reasons for early termination from trial in tSCLC enrolled.

Other outcomes

  1. Bio-specimen collection

    Time frame: 12 months

    Percentage of blood collections during trial in overall enrolled and in SCLC enrolled compared to in tSCLC enrolled.

    Reasons for failure to obtain blood collections. Percentage of successful blood collections during trial (Overall and in SCLC compared to tSCLC).

    Reasons for failure to obtain blood collections. Percentage of successful blood collections during trial (Overall and in SCLC compared to tSCLC). Reasons for failure to obtain blood collections.

  2. Subject Surveys (baseline and at 3 months)

    Time frame: 3 months

    Percentage of successful Survey completions; at baseline; at Month 3. Reasons for failure to complete Survey(s).

Study contacts

Contact information is provided by the study sponsor or research team.

Allison Harper, PharmD

CONTACT

[email protected]

833-333-7252

Sponsors and collaborators

Lead sponsor

Addario Lung Cancer Medical Institute

Other

Registry information

Official study title

A Study to Evaluate a Remote, Decentralized, Direct-to-Patient Strategy for Clinical Research Engagement of Patients With Small Cell Lung Cancer (SCLC).

Acronym: SUCCEED

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 3, 2024
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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