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Not yet recruiting NCT07088341

Role of Programmed Death Ligand 1 in Colorectal Cancer

Observational Colo-rectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: elisa.
Who it may be relevant to
Registry conditions: Colo-rectal Cancer. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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 .

Detailed description

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.

Interventions

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

Primary outcome measures

  • Study the expression level of sPDL 1 in colorectal cancer by ELISA [Time frame: baseline]

Eligibility criteria

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

2\. Patients did not undergo colorectal surgery

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Exclusion criteria

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Shao W, Xu Y, Lin S, Gao J, Gao J, Wang H. The potential of soluble programmed death-ligand 1 (sPD-L1) as a diagnosis marker for colorectal cancer. Front Oncol. 2022 Aug 16;12:988567. doi: 10.3389/fonc.2022.988567. eCollection 2022. PMID 36052227

Identifiers

NCT: NCT07088341 · sPDL-1 in colorectal cancer

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗