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Not yet recruitingNCT07088341SPDL1Updated Jul 28, 2025

Role of Programmed Death Ligand 1 in Colorectal Cancer

An observational study in Colo-rectal Cancer, sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2025-07-28.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
90
Sex
All
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Study summary

  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 .
Read the 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.

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Conditions studied

  • Colo-rectal Cancer

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03

In context

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

This study's planned enrollment of 90 is below the median of 280 across 349 observational studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Cases and controls will be recruited from clinical pathology department at South Egypt Cancer Institute, and Assuit University Hospital

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

-

Exclusion Criteria:

-

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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
90 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • Diagnostic testelisa

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

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What researchers measure

Primary outcomes

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

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

    Time frame: baseline

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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 36052227 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07088341
Lead sponsor
Assiut University
Responsible party
Marwa Mamdouh Mohamed Abdellah (resident doctor, Assiut University) — Principal investigator
First posted
Jul 28, 2025
Start date
Aug 1, 2025 (estimated)
Primary completion
Aug 30, 2026 (estimated)
Completion
Sep 1, 2026 (estimated)
Last update
Jul 28, 2025

Study contacts

marwa mamdouh mohamed abdellah, residant doctor
Contact
marwaamamdouh26@gmail.com
01153538300 ext. 01010951943

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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