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NCT Number: NCT07088341

Role of Programmed Death Ligand 1 in Colorectal Cancer

1. - Evaluation of diagnostic importance of soluble programmed death ligand-1 in patient with recently diagnosed as Colorectal cancer at different stages of disease . 2. Correlation of SPDL-1 level and clinco-pathological data of patients at presentation .

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Key information

About this study

Colorectal cancer (CRC) is a significant cause of cancer- related deaths worldwide, and its incidence and mortality are increasing each year. It accounts for approximately 10% of all annually diagnosed cancers and cancer-related deaths worldwide[1]

Most colon cancer is sporadic, and approximately 5 percent are due to an inherited genetic mutation, mostly due to Lynch syndrome (hereditary nonpolyposis colon cancer or HNPCC) and familial adenomatous polyposis (FAP). The transition from normal colon epithelium to invasive cancer takes several years and most commonly follows a sequence characterized by the accumulation of genetic mutations, adenoma formation, and subsequent carcinogenesis (adenoma-carcinoma sequence).

Programmed death-1 (PD-1) is an immunoglobulin superfamily type I transmembrane glycoprotein consisting of 288 amino acids, which is expressed on different immune cells, especially on T cells[2]. Programmed death ligand 1 (PD-L1) is one ligand of PD-1. Soluble programmed death ligand 1 (sPD-L1) is released from PD-L1-positive cells, which binds to receptor of PD-1, participates in immune regulation [2]. Furthermore, sPD-L1 was found to be involved in tumour-associated immune suppression and host immune damage, thereby promoting cancer progression and subsequent adverse clinical out- comes[3]. In addition, high level of sPD-L1 maybe also associated with the prognosis of malignancies, including colorectal cancer PD-L1, an immune-regulatory molecule, is highly expressed on tumor cells and can be present on activated T and B cell dendritic cells (4). The activation of the programmed death protein 1/programmed death ligand 1 (PD-1/PD-L1) pathway was found as one of the key mechanisms in tumor immune evasion (5). Thus, antibody- based immunotherapies blockading the PD-1/PD-L1 signaling pathways in the tumor microenvironment and stimulating the T-cell anti-tumor activity are a promising approach for developing novel tumor therapeutics in routine clinical practices.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients at South Egypt Cancer institute and Assuit University Hospital Recently diagnosed as colorectal cancer patients at different stages.

  • Patients did not undergo colorectal surgery

-

Exclusion criteria

-

Treatment and study plan

ELISA

Diagnostic Test

enzyme- linked immunesorbent assay ( ELISA ) was used to measure soluble programmed death ligand-1 level

Primary outcomes

  1. Study the expression level of sPDL 1 in colorectal cancer by ELISA

    Time frame: baseline

    Correlate the expression level of sPDL-1 and stage of disease

Study contacts

Contact information is provided by the study sponsor or research team.

marwa mamdouh mohamed abdellah, residant doctor

CONTACT

[email protected]

01153538300 ext. 01010951943

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

the Role of Programmed Death Ligand 1 in Diagnosis of Colorectal Cancer

Acronym: SPDL1

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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