Ignite Creation Date:
2024-07-17 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486428
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-12-15
Brief Title:
Small Cell Lung Cancer Community Engagement to Eliminate Research Disparities
Sponsor:
Addario Lung Cancer Medical Institute
Organization:
Addario Lung Cancer Medical Institute
Study Overview
Official Title:
A Pilot Feasibility Study to Assess the Effectiveness of a Remote Decentralized Blood Collection Strategy to Successfully Enroll Patients With Small Cell Lung Cancer SCLC and Collect Blood Samples for Future SCLC Plasma Genomics Studies and to Compare Barriers to Study Engagement Among These Two Primary SCLC Populations de Novo or Transformed
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUCCEED
Brief Summary:
This pilot feasibility study will evaluate if a direct-to-patient de-centralized remote blood collection approach will improve outreach to SCLC patients and enable successful collection of samples for bio-banking for future use The study will also assess the ability of this patient population to adequately self-report medical information such as diagnoses medical history and treatment history as well as to gather information on care and quality of life impacts and preferences through an initial and 4-month follow up survey
Detailed Description:
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 identified by local clinical care teams will be referred to contact staff 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 questionnairesurvey documenting their self-report diagnosis treatment history factors impacting care and quality of life and needspreferences regarding supportive resources
Two main patient cohorts will be recruited for this study The first will be patients diagnosed with primary SCLC The second will be patients diagnosed with primary NSCLC who experienced histological transformation with a SCLC component after initial diagnosis and subsequent treatment Transformed Small Cell Lung Cancer or tSCLC Equal numbers of patients should be enrolled in each of these cohorts
Two main patient cohorts will be recruited for this study The first will be patients diagnosed with primary SCLC The second will be patients diagnosed with primary NSCLC who experienced histological transformation with a SCLC component after initial diagnosis and subsequent treatment Transformed Small Cell Lung Cancer or tSCLC Equal numbers of patients should be enrolled in each of these cohorts
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None