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

Completed

• Conditions: Tumor Associated Neutrophils
• Interventions: Other: No different intenvention

• Registration Number: NCT06495827
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2020-07
• Study Completion: 2023-08
• Status Verified: 2024-07
• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-07-10
• Last Update Submitted: 2024-07-10
• Study First Posted: 2024-07-11
• Last Update Posted: 2024-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 653

Inclusion Criteria

1. Voluntarily sign a written ICF.

2. The Eastern Cancer Collaborative Organization (ECOG) has a physical fitness score of 0 or 1.

3. The expected survival period is ≥ 3 months.

4. Subjects diagnosed with metastatic colorectal adenocarcinoma by histology or cytology.

5. Colorectal cancer patients who have not received systematic anti-tumor therapy in the past.

Exclusion Criteria

1. 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.).
2. Simultaneously enroll in another clinical study, unless it is an observational, non-interference clinical study or a follow-up period of an intervention study.
3. Received systematic anti-tumor therapy (chemotherapy) within 3 weeks prior to the first administration

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
response cohort	No different intenvention	CRC patients with response status after chemotherapy
resistance cohort	No different intenvention	CRC patients with resistance status after chemotherapy

Primary Outcome Measures

Name	Time	Method
PFS	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