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NCT03603002 · ClinicalTrials.gov registry record · NA

Pathologic and Immunologic Response After Ablative Radiation in Lung Cancer

A NA study of Non-small Cell Lung Cancer Stage I, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Completed
Registry status
NA
Development phase
6
Enrollment target
1
Study location

NCT03603002: Completed NA study of Non-small Cell Lung Cancer Stage I, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

NCT03603002 is a NA study of Non-small Cell Lung Cancer Stage I that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 6 participants, below the 39-participant average among 3 other Non-small Cell Lung Cancer Stage I 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.

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The verdict

NCT03603002, a NA study of Non-small Cell Lung Cancer Stage I, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

COMPLETED
Registry status
NA
Development phase
6 participants
Enrollment target
1
Study location

Study Summary

This is a pilot study to compare pre- and post-SABR core biopsies of stage I NSCLC tumors to identify SABR-induced immune-mediated tumor recognition based on a significant and specific expansion of T-cell clones using a novel T-cell receptor (TCR) sequencing assay. This will be coupled with (1) novel genomic analysis of candidate tumor antigens that may be released from the pre-SABR tumor and (2) functional validation assays to screen post-treatment peripheral blood T-cells for reactivity to these released candidate tumor antigens. In addition, cell-based analysis will be used to identify changes in key T-cell infiltrates into the post-SABR tumor.

Primary Outcome

T-cell receptor (TCR) profile changes in the tumor using TCR sequencing.

Conditions Studied

Non-small Cell Lung Cancer Stage I

Interventions

  • DIAGNOSTIC_TEST Post-SABR Biopsy

Study Locations (1)

Maryland

  • Bayview Medical Center - Baltimore

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2018-10-16
Est. Completion 2025-06-27
Phase NA
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

523 total trials

What the finished NCT03603002 record still lists

NCT03603002 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 39-participant average among 3 other Non-small Cell Lung Cancer Stage I trials with a reported enrollment target (85% lower).

The record links to 1 condition, with Non-small Cell Lung Cancer Stage I appearing as the primary indexed condition, and to 1 intervention - of which Post-SABR Biopsy is the first listed.

NCT03603002 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT03603002 about?

NCT03603002 is a clinical study titled "Pathologic and Immunologic Response After Ablative Radiation in Lung Cancer". This is a pilot study to compare pre- and post-SABR core biopsies of stage I NSCLC tumors to identify SABR-induced immune-mediated tumor recognition based on a significant and specific expansion of T-cell clones using a novel T-cell receptor (TCR) sequencing assay. This will be coupled with (1) nove...

What is the current status of trial NCT03603002?

This trial is currently completed. It is a NA study. The enrollment target is 6 participants. The study started on 2018-10-16. Estimated completion is 2025-06-27.

What conditions does trial NCT03603002 study?

This clinical trial studies the following conditions: Non-small Cell Lung Cancer Stage I.

What interventions are being tested in trial NCT03603002?

The interventions under investigation include: Post-SABR Biopsy (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT03603002?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03603002 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT03603002, the US trial registry maintained by the National Library of Medicine. NCT03603002 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.