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Use Peripheral Blood Proteomics to Predict the Treatment Response and Toxicities in NSCLC Immunotherapy

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ClinicalTrials.gov Identifier: NCT03951012
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
Biodesix, Inc.
Information provided by (Responsible Party):
Taher Abu Hejleh, University of Iowa

Brief Summary:
Peripheral blood contains enormous quantity of biological information that can improve our patient care. Investigators plan to use proteomics from serum to study its value in predicting the therapeutic response and toxicities of immunotherapy in non-small cell lung cancer (NSCLC).

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Procedure: Blood draw

Detailed Description:
An extra tube of blood for research will be collected from consented subjects prior to the initiation of anti-PD-1/L1 based immunotherapy, either single agent or in combination with chemotherapy. The blood will be coded, processed and sent for analysis. Results of analysis will be correlated with clinical data to see whether serum proteomics can be a good therapeutic predictor for future studies and treatments of NSCLC.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Use Peripheral Blood Proteomics to Predict the Treatment Response and Toxicities in NSCLC Immunotherapy
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Blood draw
    Participants will be approached during their regular clinic visits and asked if an extra tube of blood may be collected prior to the treatment. If consent is not obtained before this visit, a participant will be asked later in the same day. The amount of blood collected will be 2 teaspoons (10mL).


Primary Outcome Measures :
  1. Treatment response [ Time Frame: Time of study enrollment up to one year ]
    Treatment response will be measured every 2-3 months using iRECIST criteria.

  2. Treatment toxicities [ Time Frame: Time of study enrollment up to one year ]
    The treatment toxicities will be recorded using CTCAE version 5.0

  3. Correlate peripheral blood proteomics data with patients' clinical information [ Time Frame: Time of study enrollment up to one year ]
    An extra tube of peripheral blood (~10ml) will be collected prior to the treatment. This blood specimen will be spun down and the serum collected and aliquoted. ~1ml serum will be shipped to Biodesix Inc. for the analysis of blood proteomics using matrix-assisted laser/desorption ionization (MALDI) mass spectrometry. We will correlate proteomics data with patients clinical information including treatment response, toxicities, tumor mutation/PD-L1 status, etc. to determine if peripheral blood protemoics can predict therapeutic response.


Biospecimen Retention:   Samples Without DNA
Participants will be approached during their regular clinic visits and asked if an extra tube of blood may be collected prior to the treatment. If consent is not obtained before this visit, a participant will be asked later in the same day. The amount of blood collected will be 2 teaspoons (10mL).


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants are current patients at Holden Comprehensive Cancer Center undergoing immunotherapy for Non Small Cell Lung Cancer (NSLC) prior to first chemotherapy treatment.
Criteria

Inclusion Criteria:

  • Non Small Cell Lung Cancer (NSCLC) patients who were previously untreated receiving anti-PD1 or anti-PD-L1 therapies, either single agent or in combination with chemotherapy.
  • NSCLC patients who were treated with one previous line of therapy (not containing IO) and now receiving anti-PD1 or anti-PD-L1 therapies, either single agent or in combination with chemotherapy.

Exclusion Criteria:

  • Patients not capable of making medical decisions
  • Any patients who do not meet the inclusion criteria

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): NCT03951012


Contacts
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Contact: Taher Abu Hejleh, MBBS 319-384-9502 taher-hejleh@uiowa.edu

Locations
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United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Taher Abu Hejleh, MBBS    319-384-9502    taher-hejleh@uiowa.edu   
Sponsors and Collaborators
Taher Abu Hejleh
Biodesix, Inc.
Investigators
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Principal Investigator: Taher Abu Hejleh, MBBS University of Iowa

Publications:
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Responsible Party: Taher Abu Hejleh, Clinical Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03951012     History of Changes
Other Study ID Numbers: 201710764
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases