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A Pilot Study of Blood-based Biomarkers for Response to Immune Checkpoint Inhibitors
NCT06630429 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06630429
The ClinicalTrials.gov registry entry for NCT06630429 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University Comprehensive Cancer Center, which has 291 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06630429 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06630429?
The interventions under investigation include: Biospecimen Collection (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06630429?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 291 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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