Modulatory Effect of Prodigiosin or Pioglitazone on TIME and the Crosstalk to Immune-Checkpoint Protein(s)

NCT06502249 | Not Yet Recruiting

• 1 other identifier: P#2
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer is one of the most common and serious types of cancer. Lung tumor cells exploit immune checkpoint proteins (ICPs) to maintain immune tolerance and thus promote tumor progression and invasion. Inhibition of ICPs using antibody therapies is one of the most common approaches for the treatment of lung cancer. Unfortunately, these antibody-based therapies can lead to severe adverse events. Moreover, a significant number of patients do not respond to immune checkpoint inhibition due to tumor heterogeneity and the immunosuppressive tumor immune microenvironment (TIME). The use of small molecule targeted approach instead of antagonizing antibodies may have the potential advantage of being able to target multiple ICPs in TIME with a single agent as well as improved tumor distribution.

Conditions

Lung Cancer; NSCLC

Keywords

Immune checkpoint proteins; pioglitazone; prodigiosin; TIME

Outcome Measures

Primary Outcomes (4)

• Gene Expression (mRNA levels)

  mRNA levels of HSP90, IL-6, STAT3,c-MYC and the novel immune checkpoint proteins by qRT-PCR from blood samples collected from NSCLC patients and cell pellets collected from lung cancer cell lines before and after pioglitazone or prodigiosin treatment

  36 months

• Gene Expression (Protein levels)

  Protein levels of HSP90, IL-6, STAT3,c-MYC and the novel immune checkpoint proteins by immunoblotting from blood samples collected from NSCLC patients and cell pellets collected from lung cancer cell lines before and after pioglitazone or prodigiosin treatment

  36 months

• cytotoxic effect

  Cytotoxic effect of prodigiosin or pioglitazone on lung cancer cell line using MTT assay

  36 months

• Anti-cancer efficiency of drug-loaded nanoparticles

  Anticancer efficiency against lung cancer in vivo model using Urethan as lung cancer inducer or in vitro lung cancer cell line

  36 months

Study Arms (2)

control

Healthy volunteers not suffering from any disease or not taking any Medications

Diseased

NSCLC patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Lung cancer patients diagnosed with non-small cell lung cancer and healthy volunteers not suffering from any disease will be enrolled in the study

You may qualify if:

• Adults over 50 years old with NSCLC.

You may not qualify if:

• Lung cancer patients with any cancer other than NSCLC
• Lung cancer patients with incomplete data or incomplete histopathology diagnosis report.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Pharmacy, Ain Shams University, Advanced Biochemistry Research Lab

Cairo, 11566, Egypt

Location

Related Publications (20)

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Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected and stored at -20°c. RNA will then be extracted followed by cDNA synthesis

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nadia Hamdy, PhD

  Faculty of pharmacy Ain Shams university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadia Hamdy, PhD

CONTACT

00201009570210; nadia_hamdy@pharma.asu.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of biochemistry and molecular biology

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: July 16, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

EG (1)