Immunological Markers Screening for Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02222753
• Other study ID #: 2014AA020801
• Status: Recruiting
• Phase: N/A
• First received: August 20, 2014
• Last updated: August 20, 2014
• Start date: January 2014

Study information

• Verified date: August 2014
• Source: State Key Laboratory of Cancer Biology
• Contact: Long Cui, M.D.
• Email: longcuidr[@]126.com
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
China	Shanghai Jiaotong University	Shanghai	Shanghai

Sponsors (8)

Lead Sponsor	Collaborator
State Key Laboratory of Cancer Biology	Beijing Cancer Hospital, China-Japan Friendship Hospital, Chinese Academy of Medical Sciences, Chinese PLA General Hospital, Fourth Military Medical University, Second Military Medical University, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	Overall survival	Overall survival is defined as the time elapsed from surgery to the date of death from any cause.	5 years	No