Immunological Markers Screening for Colorectal Cancer

NCT ID: NCT02222753

Last Updated: 2014-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Brief Summary

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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

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Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Air Force Military Medical University, China

OTHER

Sponsor Role collaborator

Second Military Medical University

OTHER

Sponsor Role collaborator

China-Japan Friendship Hospital

OTHER

Sponsor Role collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

State Key Laboratory of Cancer Biology

NETWORK

Sponsor Role lead

Responsible Party

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Dake Chu

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Long Cui, M.D.

Role: STUDY_CHAIR

Shanghai Jiao Tong University School of Medicine

Locations

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Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Long Cui, M.D.

Role: CONTACT

Facility Contacts

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Long Cui, M.D.

Role: primary

Other Identifiers

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2014AA020801

Identifier Type: -

Identifier Source: org_study_id

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