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Not yet recruiting NCT07586293

Histidine and Immunotherapy Response in Colorectal Cancer

— Observational Colorectal 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: Immunohistochemistry or immunofluorescence, Serum metabolomic analysis or ELISA, Flow cytometry.
Who it may be relevant to
Registry conditions: Colorectal Cancer. Basic parameters: from 18 years · 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 →

Unsure about the terms? Read our patient guide →

Official title

Mechanistic Study of Histidine-mediated Regulation of Antigen Presentation in Colorectal Cancer to Enhance Sensitivity to Immunotherapy

Overview

This observational study aims to investigate the role of histidine and its transporter SLC15A3 in modulating the sensitivity of colorectal cancer to immunotherapy. By analyzing the expression of SLC15A3 in tumor/normal colonic tissues from patients with colorectal cancer and assessing serum histidine metabolic levels, the study seeks to identify potential targets associated with therapeutic resistance and explore possible intervention strategies to improve immune checkpoint blockade treatment efficacy.

Interventions

  • Other Immunohistochemistry or immunofluorescence
    Formalin-fixed paraffin-embedded (FFPE) colorectal tumor and adjacent normal tissue specimens will be analyzed for SLC15A3 expression by immunohistochemistry and/or immunofluorescence.
  • Other Serum metabolomic analysis or ELISA
    Serum specimens from patients with colorectal cancer will be analyzed for histidine and related metabolites and selected biomarkers by metabolomics and/or ELISA.
  • Other Flow cytometry
    Peripheral blood mononuclear cells (PBMCs) will be separated from whole blood samples and assessed for immune cell phenotype and functional markers by flow cytometry.

Primary outcome measures

  • SLC15A3 expression [Time frame: Baseline archival tissue specimen from surgical resection or diagnostic biopsy.]
  • Serum histidine concentration [Time frame: Baseline and after 9 weeks (one round of treatment).]
Secondary outcome measures (5)
  • Progression-free survival [Time frame: 5 years.]
  • Overall survival [Time frame: 5 years.]
  • Percentage of IFN-gamma-positive T cells [Time frame: Baseline and after 9 weeks (one round of treatment).]
  • Percentage of granzyme B-positive T cells [Time frame: Baseline and after 9 weeks (one round of treatment).]
  • Clinicopathological characteristics [Time frame: Baseline at initial diagnosis or tissue collection.]

Eligibility criteria

Inclusion criteria

  • Participants aged ≥18 years and ≤100 years.
  • Patients pathologically diagnosed with colorectal cancer based on colonoscopy or surgical specimens and biopsy examination; or patients who previously received PD-1 monoclonal antibody immunotherapy for colorectal cancer.

Exclusion criteria

  • Age <18 years.
  • Presence of poorly controlled metabolic diseases, including hypertension, diabetes mellitus, hyperlipidemia, hyperuricemia, or hyperthyroidism.
  • Presence of other severe gastrointestinal diseases, including inflammatory bowel disease, ischemic bowel disease, familial adenomatous polyposis, liver cirrhosis, MUTYH-associated polyposis (MAP), Lynch syndrome (LS), or Peutz-Jeghers syndrome (PJS).
  • History of other malignant tumors, or pathological diagnosis of colorectal inflammatory polyps, hyperplastic polyps, neuroendocrine tumors, neuroendocrine carcinoma, or mixed neuroendocrine-non-neuroendocrine neoplasms.
  • History of neurological or psychiatric disorders, such as epilepsy or depression.
  • Unqualified specimens, including hemolyzed serum samples or tissue samples that were not properly preserved in time.

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

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07586293 · KY2025-053-B

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗