The Detection Of Circulating Tumor Cells (CTC) In Patients With NSCLC Undergoing Definitive Radiotherapy Or Chemoradiotherapy

NCT ID: NCT02135679

Last Updated: 2024-11-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

204 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2021-12-31

Brief Summary

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CTC levels collected pre-surgery will be correlated with pathological samples.

Detailed Description

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Patients with NSCLC who undergo radiation as part of a definitive course of treatment will be enrolled. Blood collections will be obtained before, during, and after radiotherapy. We will collect demographic and treatment data and explore \& describe the pattern of CTC detection in all patients

Conditions

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Non-small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

Patients with early stage NSCLC undergoing stereotactic radiotherapy

Radiotherapy

Intervention Type RADIATION

Cohort 2

Patients with locally advanced NSCLC undergoing standard chemoradiotherapy

Radiotherapy

Intervention Type RADIATION

Cohort 3

Patients with stage I-III NSCLC undergoing standard, fractionated radiotherapy alone

Radiotherapy

Intervention Type RADIATION

Cohort 4

Patients with locally advanced NSCLC undergoing standard chemoradiotherapy with the novel signal transduction inhibitor, nelfianvir.

Radiotherapy

Intervention Type RADIATION

Cohort 5

Patients with resectable stage IIIa NSCLC undergoing pre-operative chemoradiotherapy

Radiotherapy

Intervention Type RADIATION

Cohort 6

Patients with suspected (no tissue diagnosis) early stage NSCLC undergoing stereotactic radiotherapy

Radiotherapy

Intervention Type RADIATION

Cohort 7

Patients with locally advanced NSCLC undergoing stereotactic radiotherapy followed by concurrent mediastinal chemoradiotherapy

Radiotherapy

Intervention Type RADIATION

Interventions

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Radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Patients with biopsy-proven NSCLC who are undergoing definitive radiotherapy as a part of their treatment regimen.
* Age 18 or older
* Signed informed consent
* Patients who are incapable of providing informed consent are excluded from participating in this study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Feigenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

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Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Evanson D, Griffin M, O'Reilly SE, Johnson T, Werner T, Kothekar E, Jahangiri P, Simone CB 2nd, Swisher-McClure S, Feigenberg SJ, Revheim ME, Zou J, Alavi A. Comparative assessment of radiation therapy-induced vasculitis using [18F]FDG-PET/CT in patients with non-small cell lung cancer treated with proton versus photon radiotherapy. Eur J Nucl Med Mol Imaging. 2024 Apr;51(5):1444-1450. doi: 10.1007/s00259-023-06535-3. Epub 2023 Dec 14.

Reference Type DERIVED
PMID: 38095673 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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UPCC 12512

Identifier Type: -

Identifier Source: org_study_id

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