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

November 4, 2024 updated by: Abramson Cancer Center at Penn Medicine

The Detection Of Circulating Tumor Cells (CTC) In Patients With Non-small Cell Lung Cancer (NSCLC) Undergoing Definitive Radiotherapy Or Chemoradiotherapy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

204

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of The University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

NSCLC patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1
Patients with early stage NSCLC undergoing stereotactic radiotherapy
Radiation: Radiotherapy
Cohort 2
Patients with locally advanced NSCLC undergoing standard chemoradiotherapy
Radiation: Radiotherapy
Cohort 3
Patients with stage I-III NSCLC undergoing standard, fractionated radiotherapy alone
Radiation: Radiotherapy
Cohort 4
Patients with locally advanced NSCLC undergoing standard chemoradiotherapy with the novel signal transduction inhibitor, nelfianvir.
Radiation: Radiotherapy
Cohort 5
Patients with resectable stage IIIa NSCLC undergoing pre-operative chemoradiotherapy
Radiation: Radiotherapy
Cohort 6
Patients with suspected (no tissue diagnosis) early stage NSCLC undergoing stereotactic radiotherapy
Radiation: Radiotherapy
Cohort 7
Patients with locally advanced NSCLC undergoing stereotactic radiotherapy followed by concurrent mediastinal chemoradiotherapy
Radiation: Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To Describe the Pattern of CTCs Before and After Definitive Radiotherapy for Each Treatment Stratum
Time Frame: 24 months
The pattern of CTCs before and after definitive radiotherapy for each treatment stratum. CTC counts per mL before and after definitive radiotherapy.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Investigators

  • Principal Investigator: Steven Feigenberg, MD, Abramson Cancer Center at Penn Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

May 2, 2014

First Submitted That Met QC Criteria

May 8, 2014

First Posted (Estimated)

May 12, 2014

Study Record Updates

Last Update Posted (Actual)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 12512

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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