NCT05082636

Brief Summary

This study was designed to investigate the correlation of lung cancer tissue expression of both PDL-1-mRNA ,vitamin D receptor (VDR) and level of vit.D in sera of lung cancer patients.These three biochemical markers may interact and play a role in lung cancer progression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed
Last Updated

October 25, 2021

Status Verified

October 1, 2021

Enrollment Period

2 years

First QC Date

September 24, 2021

Last Update Submit

October 18, 2021

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • measuring expression of PDL-1,VDR in cancer patients and healthy control.

    we measured PDL-1 and VDR expressions by real time q-PCR, in lung cancer tissues from patients with stage I and II LC and healthy controls who were clinically suspicious with chest masses and proven histopathologically to be negative cancer .

    through study completion, an average of 1 year.

Secondary Outcomes (1)

  • measuring serum Vit D level by EIA method

    through study completion, an average of 1 year.

Study Arms (2)

case

54 patients with early stage lung (stage I, II) cancer (Group 1) were selected from the Chest Department of Assiut University Hospital,

Other: Observational Study ( Tissue Biopsy )

control

besides 36 healthy controls; who were clinically suspicious with chest masses and proven histopathologically to be negative cancer (Group 2).

Other: Observational Study ( Tissue Biopsy )

Interventions

Observational Study ( Tissue Biopsy )OTHER

control study includes a total of 90 subjects. Of them 54 patients with early stage lung (stage I, II) cancer (Group 1) were selected from the Chest Department of Assiut University Hospital, besides 36 healthy controls; who were clinically suspicious with chest masses and proven histopathologically to be negative cancer (Group 2).obtained by fiberoptic bronchoscopy

casecontrol

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The mean age ±S.E for controls was 55.47 ± 1.5 year, while that of lung cancer cases was 56.31 ± 0.83 years. All patients were subjected to a full history taking, physical examination, routine laboratory investigations as blood picture, liver function, chest x- rays, chest ultrasonography. For patients who had been suspected clinically to have lung cancer, by examining the lung tissue obtained by fiberoptic bronchoscopic, the final diagnosis was confirmed histopathologically.

You may qualify if:

  • newly diagnosed histopathologically proven stage I and II lung cancer.

You may not qualify if:

  • : patients who have pulmonary secondaries or metastasis (usually multiple and widespread tumors), and who received treatment for lung cancer or those suffering from other malignancies elsewhere were excluded from the current study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

Related Publications (3)

  • Ceeraz S, Nowak EC, Noelle RJ. B7 family checkpoint regulators in immune regulation and disease. Trends Immunol. 2013 Nov;34(11):556-63. doi: 10.1016/j.it.2013.07.003. Epub 2013 Aug 13.

    PMID: 23954143BACKGROUND

  • Zhang Y, Jiang X, Li X, Gaman MA, Kord-Varkaneh H, Rahmani J, Salehi-Sahlabadi A, Day AS, Xu Y. Serum Vitamin D Levels and Risk of Liver Cancer: A Systematic Review and Dose-Response Meta-Analysis of Cohort Studies. Nutr Cancer. 2021;73(8):1-9. doi: 10.1080/01635581.2020.1797127. Epub 2020 Jul 24.

    PMID: 32705896BACKGROUND

  • Kim SH, Chen G, King AN, Jeon CK, Christensen PJ, Zhao L, Simpson RU, Thomas DG, Giordano TJ, Brenner DE, Hollis B, Beer DG, Ramnath N. Characterization of vitamin D receptor (VDR) in lung adenocarcinoma. Lung Cancer. 2012 Aug;77(2):265-71. doi: 10.1016/j.lungcan.2012.04.010. Epub 2012 May 6.

    PMID: 22564539BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching and Research Assistant

Study Record Dates

First Submitted

September 24, 2021

First Posted

October 19, 2021

Study Start

June 15, 2018

Primary Completion

June 20, 2020

Study Completion

March 25, 2021

Last Updated

October 25, 2021

Record last verified: 2021-10

Locations

EG(1)