Immunological Markers Screening for Colorectal Cancer

• Conditions: Colorectal Cancer

• Registration Number: NCT02222753
• Lead Sponsor: State Key Laboratory of Cancer Biology

Brief Summary

Colorectal cancer incidence is increasing at an alarming rate in China. Recent reports concluded aberrant immunological function was associated with colorectal cancer outcome, however, the influence of immunocyte subgroup and immunologic factors on cancer outcome in colorectal cancer survivors is largely unknown.The investigators will explore the impact of immunocyte subgroup and immunologic factors on colorectal cancer disease-specific, disease-free and overall survival. The investigators will recruit approximately 5,000 patients as a prospective study cohort. During follow up, the investigators will explore the association of these factors with outcome of patients. The investigators believe that this project will improve the understanding of the impact of immunocyte subgroup and immunologic factors on colorectal cancer outcome.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Status Verified: 2014-08
• Study First Submitted: 2014-08-20
• Study First Submitted QC: 2014-08-20
• Last Update Submitted: 2014-08-20
• Study First Posted: 2014-08-21
• Last Update Posted: 2014-08-21
• Primary Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Patient must have a histologically proven adenocarcinoma of colon or rectum cancer.

• Patients must have a performance status of 0,1, or 2 by the Southwest Oncology Group criteria.
• Patients must have recovered from any effects of surgery.
• Evaluable disease must be present outside radiation field. At least 3 weeks must have elapsed after discontinuation of radiation therapy.
• Patients must provide a signed consent to participate in the study.
• Patients must complete all questionnaires.

Exclusion Criteria

Patients with a proven history of peptic ulcer disease or gastroesophageal reflux.

• History of other malignancy, except for cancers that have been treated with a curative intent and patient is without evidence of active disease.
• Unresolved bacterial infection requiring treatment with antibiotics.
• Pregnant or lactating women may not participate in the study.
• Patients known to have HIV-1 virus infection because of the undetermined effect of this chemotherapy regimen in patients with HIV-1 and the potential for serious interaction with anti-HIV medications.
• Gilbert's disease.
• Other serious concurrent infection
• Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction within the last 12 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-specific survival	5 years	Disease-specific survival is defined as the time elapsed from surgery to death due to CRC. Concretely, the cause of death obtained in the follow up was classified according to ICD-10 conventions. Disease-specific deaths included those with an underlying cause attributed to ICD-10 codes C18.0-C20.0 or C26.0.

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years	Overall survival is defined as the time elapsed from surgery to the date of death from any cause.

Trial Locations

Locations (1)

Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China