Expressiona and Diagnostic Potential of miRNAs in NSCLC

• Sponsor: Al-Azhar University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05815407
• Collaborator: National Cancer Institute, Cairo University, Egypt (Other)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 49
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

Its to explore the expression pattern, diagnostic and prognostic potentials of miRs (106b-5p, 601 and 760) in serum of NSCLC patients

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Other: No intervention

Detailed Description

A retrospective observational study on NSCLC patients, to determine the serum expression levels if some miRNAs in NSCLC patients and to find if having proper diagnostic and prognostic values in early disease detection, and/or staging.

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: The Expression Profiling of Serum miRNAs (106b-5p, 601, and 760) in Non-small Cell Lung Cancer Patients
• Actual Study Start Date: Sep 1, 2018
• Actual Primary Completion Date: Sep 30, 2022
• Actual Study Completion Date: Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
NSCLC patients Patients were diagnosed with NSCLC at any stage, then will be subdivided into Early stage, Lympho-node involvement stage and Distant metastatic stage	Other: No intervention; No intervention
Control subjects Appearantly healthy age-matched individuals	Other: No intervention; No intervention

Outcome Measures

Primary Outcome Measures

1. Determination of the expression [By the end of the study (September 2022)]

   Expression profiling of the selected miRNAs

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• First time and recently diagnosed NSCLC patient

Exclusion Criteria:

• Recurrent NSCLC

• Start of chemotherapy, radiotherapy or surgical intervention

• Previous treatment

• Cancer history

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Pharmacy, Al-Azhar University, Cairo, Egypt	Cairo		Egypt	11231

Sponsors and Collaborators

• Al-Azhar University
• National Cancer Institute, Cairo University, Egypt

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Elshafei, Professor Associate of Medical Biochemistry and Molecular Biology, Al-Azhar University
• ClinicalTrials.gov Identifier: NCT05815407
• Other Study ID Numbers: FOP AlAzharU
• First Posted: Apr 18, 2023
• Last Update Posted: Apr 18, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Apr 18, 2023