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OpenTrials
Completed

NCT Number: NCT06495827

Predicting Response to Chemotherapy in Colorectal Cancer Via Multi-dimensional Analyses of the Tumor Associated Neutrophils

A single biomarker is not adequate to identify patients with colorectal cancer (CRC) who have the potential to benefit from adjuvant therapy, presumably owing to the complexity of tumor-infiltrating immune cells (TIICs). The density and spatial organization of TIICs has not been definitely established to explore their predictive value. This study aimed to investigate the prognostic significance of TIICs and its biological predictive value in CRC.

Completed

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Key information

Conditions

Tumor Associated Neutrophils

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Voluntarily sign a written ICF.
  • The Eastern Cancer Collaborative Organization (ECOG) has a physical fitness score of 0 or 1.
  • The expected survival period is ≥ 3 months.
  • Subjects diagnosed with metastatic colorectal adenocarcinoma by histology or cytology.
  • Colorectal cancer patients who have not received systematic anti-tumor therapy in the past.

Exclusion criteria

  • Subjects suffered from other malignant tumors within 3 years before enrollment, except for cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, etc.).
  • Simultaneously enroll in another clinical study, unless it is an observational, non-interference clinical study or a follow-up period of an intervention study.
  • Received systematic anti-tumor therapy (chemotherapy) within 3 weeks prior to the first administration

Treatment and study plan

No different intenvention

Other

No different intenvention

Primary outcomes

  1. PFS

    Time frame: From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months

    From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Zhongshan Hospital，Fudan University

Important dates

Study start
2010
Primary completion
2020
Study completion
2023
First posted
Jul 11, 2024
Registry last updated
Jul 11, 2024

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.