Tempus NSCLC Surveillance Study: A ctDNA Biomarker Profiling Study of Patients With NSCLC Using NGS Assays
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|ClinicalTrials.gov Identifier: NCT05236114|
Recruitment Status : Recruiting
First Posted : February 11, 2022
Last Update Posted : June 24, 2022
|Condition or disease||Intervention/treatment|
|Non-Small Cell Lung Cancer||Other: Observation|
|Study Type :||Observational|
|Estimated Enrollment :||338 participants|
|Official Title:||Tempus NSCLC Surveillance Study: A Longitudinal Circulating Tumor DNA (ctDNA) Biomarker Profiling Study of Patients With Non-Small Cell Lung Cancer (NSCLC) Using Comprehensive Next-Generation Sequencing (NGS) Assays|
|Actual Study Start Date :||June 22, 2022|
|Estimated Primary Completion Date :||February 2024|
|Estimated Study Completion Date :||February 2027|
Cohort 1 will include patients with early-stage and locally advanced disease (stages I-IIIa) who are candidates for definitive surgical resection.
Cohort 2 will include patients who have advanced or metastatic disease (stages IIIB-IV) and are not surgical candidates.
- Recurrence-Free Survival [ Time Frame: 2 years ]Recurrence-Free Survival as assessed by standard radiographic imaging, measured from the day of completion of definitive treatment to first radiographic recurrence or death
- Progression-Free Survival [ Time Frame: 2 years ]Progression-Free Survival as assessed by standard radiographic imaging, measured from the day of completion of definitive treatment to first radiographic progression or death
- Sensitivity [ Time Frame: 2 years ]Sensitivity defined as the proportion of participants who develop recurrence who have ctDNA detected.
- Specificity [ Time Frame: 2 years ]Specificity defined as the proportion of participants who do not develop recurrence who do not have ctDNA detected at or before the time of clinical detection of recurrence.
- Positive Predictive Value [ Time Frame: 2 years ]Positive predictive value (PPV) defined as the proportion of participants who have ctDNA detected who recur.
- Overall Survival [ Time Frame: 2 years or until the patient is reported deceased, whichever came first ]The duration of time between enrollment and death for any reason
- Lead Time [ Time Frame: 2 years ]Lead time defined as the interval between ctDNA detection and clinical detection of recurrence.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05236114
|Contact: NSCLC Surveillance Study||(833) firstname.lastname@example.org|
|United States, California|
|Fountain Valley, California, United States, 92708|
|Contact: Tuyet Collucci 562-706-1195 TCollucci@memorialcare.org|
|Principal Investigator: Amol Rao, MD|
|United States, Ohio|
|Canton, Ohio, United States, 44710|
|Contact: Carla Larch 330-363-1250 email@example.com|
|Principal Investigator: Sareena Singh, MD|
|TriHealth Cancer Institute||Recruiting|
|Cincinnati, Ohio, United States, 45220|
|Contact: Wayne Thompson 513-865-5020 Wayne_Thompson@trihealth.com|
|Principal Investigator: Leanne Budde, MD|
|United States, Wisconsin|
|ThedaCare Regional Cancer Center||Recruiting|
|Appleton, Wisconsin, United States, 54911|
|Contact: Rachel Luedtke 920-364-3616 Rachel.Luedtke@thedacare.org|
|Principal Investigator: Matthias Weiss, MD|
|Principal Investigator:||Kristiyana Kaneva, MD, MS||Tempus Labs, Inc.|