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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02135679
Recruitment Status : Suspended (Covid-19)
First Posted : May 12, 2014
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Radiation: Radiotherapy

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

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Detection Of Circulating Tumor Cells (CTC) In Patients With Non-small Cell Lung Cancer (NSCLC) Undergoing Definitive Radiotherapy Or Chemoradiotherapy
Study Start Date : September 2012
Actual Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Circulating tumor cells will be detected by imaging for green fluorescent protein (GFP) which measures cells which high levels of telomerase activity after adenovirus transduction. CTCs are measured in units of number of GFP-positive cells /mL. [ Time Frame: 24 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
NSCLC patients
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135679


Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Samuel Swisher McClure, MD Abramson Cancer Center of the University of Pennsylvania
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02135679    
Other Study ID Numbers: UPCC 12512
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplastic Cells, Circulating
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes