Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCLC (primary de novo) | Blood collection, survey (baseline and Month 3) | ||
| SCLC (transformed) | Blood collection, survey (baseline and Month 3) |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of conducting trial in SCLC population | 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. | 12 months |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Bio-specimen collection | 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. |
Inclusion Criteria:
Exclusion Criteria:
Note: Concurrent enrollment in other clinical trials is NOT exclusionary
Not provided
Not provided
Not provided
Adults (USA-based) with a diagnosis of extensive stage primary SCLC or tSCLC
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Allison Harper, PharmD | Contact | 833-333-7252 | SUCCEED@alcmi.org |
| Name | Affiliation | Role |
|---|---|---|
| Christine Lovly, MD PhD | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Alabama | 37232 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Two (2) EDTA tubes of whole blood (approx 10 mL per tube) will be sent to the ALCMI biobank for processing and storage (baseline and at month 3).
| 12 months |
| Subject Surveys (baseline and at 3 months) | Percentage of successful Survey completions; at baseline; at Month 3. Reasons for failure to complete Survey(s). | 3 months |
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Alaska | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Arizona | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Arkansas | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | California | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Colorado | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Connecticut | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Delaware | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | District of Columbia | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Florida | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Georgia | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Hawaii | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Idaho | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Illinois | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Indiana | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Iowa | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Kansas | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Kentucky | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Louisiana | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Maine | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Maryland | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Massachusetts | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Michigan | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Minnesota | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Mississippi | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Missouri | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Montana | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Nebraska | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Nevada | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | New Hampshire | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | New Jersey | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | New Mexico | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | New York | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | North Carolina | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | North Dakota | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Ohio | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Oklahoma | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Oregon | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Pennsylvania | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Rhode Island | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | South Carolina | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | South Dakota | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Tennessee | 37232 | United States |
|
| Vanderbilt-Ingram Cancer Center | Recruiting | Nashville | Tennessee | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Texas | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Utah | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Vermont | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Virginia | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Washington | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | West Virginia | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Wisconsin | 37232 | United States |
|
| Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html | Recruiting | Multiple Locations | Wyoming | 37232 | United States |
|
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided