Immunological Markers Screening for Colorectal Cancer

Therapeutic Effect and Prognosis Predication Related Immunocyte Subgroup and Immunologic Factors Screeing for Colorectal Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Long Cui, M.D.; Email: longcuidr@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200240
      • Recruiting
      • Shanghai Jiaotong University
      • Contact: Long Cui, M.D.; Email: longcuidr@126.com
      • Principal Investigator: Long Cui, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

primary care clinic

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-specific survival	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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival is defined as the time elapsed from surgery to the date of death from any cause.	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival	Disease-free survival is defined as the time elapsed from surgery to the first occurrence of any of the following events: recurrence of colorectal cancer; colorectal cancer distant metastasis; development of second non-colorectal malignancy excluding basal cell carcinomas of the skin and carcinoma in situ of the cervix; or death from any cause without documentation of a cancer-related event.	5 years

Collaborators and Investigators

• Sponsor: State Key Laboratory of Cancer Biology
• Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Chinese PLA General Hospital; Peking University Cancer Hospital & Institute; Shanghai Jiao Tong University School of Medicine; China-Japan Friendship Hospital; Air Force Military Medical University, China; Second Military Medical University
• Investigators: Study Chair: Long Cui, M.D., Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: August 20, 2014
• First Submitted That Met QC Criteria: August 20, 2014
• First Posted (Estimate): August 21, 2014

Study Record Updates

• Last Update Posted (Estimate): August 21, 2014
• Last Update Submitted That Met QC Criteria: August 20, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2014AA020801