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NCT06630429 · ClinicalTrials.gov registry record
A Pilot Study of Blood-based Biomarkers for Response to Immune Checkpoint Inhibitors
A clinical trial of Non-Small Cell Lung Cancer and Renal Cell Carcinoma (RCC), sponsored by Ohio State University Comprehensive Cancer Center.
- Active
- Registry status
- 100
- Enrollment target
- 1
- Study location
NCT06630429: Active study of Non-Small Cell Lung Cancer and Renal Cell Carcinoma (RCC), sponsored by Ohio State University Comprehensive Cancer Center.
NCT06630429 is a study of Non-Small Cell Lung Cancer and Renal Cell Carcinoma (RCC) that is active but no longer recruiting, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 100 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06630429, a study of Non-Small Cell Lung Cancer and Renal Cell Carcinoma (RCC), is active but no longer recruiting, sponsored by Ohio State University Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
A pilot study evaluating baseline and on-treatment changes in tumor fraction (TFx) in peripheral blood in patients with NSCLC and RCC being treated with checkpoint inhibitor therapy as part of standard of care. The primary objective of the study is to determine whether baseline TFx can be reliably predicted in patients with NSCLC and RCC and if changes can be detected during treatment that may correlate with response. Exploratory analyses will be completed to assess the potential roles of cachexia-associated inflammation, tumor-associated increases in glucocorticoid secretion, and ketosis/ketogenesis in both elevated mAb clearance and in response to ICI therapy. Measurements will include circulating IL-6 and other cytokine levels, glucocorticoid levels, ketone levels and stool analysis for assessment of gut microbiome.
Primary Outcome
The primary outcome is the percentage of patients having \>5% change (better or worse) in tumor fraction during the first two cycles. With 90 patients having detectable tumor fraction, the % of patients having \>5% change in tumor fraction can be estimated with a 95% confidence interval of ±10%. Assuming the response rate of 30%, 27 responders will provide at least 80% power to detect an effect size of 0.5 standard deviations reduction of tumor fraction from baseline to treatment by cycle 3 at s
Conditions Studied
Interventions
- OTHER Biospecimen Collection
Study Locations (1)
Ohio
- The Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-09-02 |
| Est. Completion | 2026-07-31 |
What the registry record for NCT06630429 still lists
NCT06630429 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (85% lower).
The record links to 2 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which Biospecimen Collection is the first listed.
NCT06630429 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06630429 about?
NCT06630429 is a clinical study titled "A Pilot Study of Blood-based Biomarkers for Response to Immune Checkpoint Inhibitors". A pilot study evaluating baseline and on-treatment changes in tumor fraction (TFx) in peripheral blood in patients with NSCLC and RCC being treated with checkpoint inhibitor therapy as part of standard of care. The primary objective of the study is to determine whether baseline TFx can be reliably p...
What is the current status of trial NCT06630429?
This trial is currently active not recruiting. The enrollment target is 100 participants. The study started on 2020-09-02. Estimated completion is 2026-07-31.
What conditions does trial NCT06630429 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Renal Cell Carcinoma (RCC).
What interventions are being tested in trial NCT06630429?
The interventions under investigation include: Biospecimen Collection (OTHER).
Who is sponsoring clinical trial NCT06630429?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06630429 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06630429's enrollment target sits among peer trials
100 233rd of 454 higher than 212 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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