Clinical trial NCT02222753: Immunological Markers Screening for Colorectal Cancer
Official title: Therapeutic Effect and Prognosis Predication Related Immunocyte Subgroup and Immunologic Factors Screeing for Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Lead sponsor: State Key Laboratory of Cancer Biology
Sponsor class: NETWORK
Collaborators: name: Shanghai Jiao Tong University School of Medicine
name: Air Force Military Medical University, China
name: Second Military Medical University
name: China-Japan Friendship Hospital
name: Chinese Academy of Medical Sciences
name: Peking University Cancer Hospital & Institute
name: Chinese PLA General Hospital
First posted: 2014-08-21
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Disease-specific survival
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
Other outcomes:
measure: Disease-free survival
timeFrame: 5 years
Locations:
city: Shanghai
country: China
facility: Shanghai Jiaotong University
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Long Cui, M.D.
role: STUDY_CHAIR
References: