Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Immunological Markers Screening for Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02222753
Recruitment Status : Unknown
Verified August 2014 by Dake Chu, State Key Laboratory of Cancer Biology.
Recruitment status was:  Recruiting
First Posted : August 21, 2014
Last Update Posted : August 21, 2014
Sponsor:
Collaborators:
Shanghai Jiao Tong University School of Medicine
Fourth Military Medical University
Second Military Medical University
China-Japan Friendship Hospital
Chinese Academy of Medical Sciences
Beijing Cancer Hospital
Chinese PLA General Hospital
Information provided by (Responsible Party):
Dake Chu, 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.

Condition or disease
Colorectal Cancer

Layout table for study information
Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Therapeutic Effect and Prognosis Predication Related Immunocyte Subgroup and Immunologic Factors Screeing for Colorectal Cancer
Study Start Date : January 2014
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Disease-specific survival [ Time Frame: 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 :
  1. Overall survival [ Time Frame: 5 years ]
    Overall survival is defined as the time elapsed from surgery to the date of death from any cause.


Other Outcome Measures:
  1. Disease-free survival [ Time Frame: 5 years ]
    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.


Biospecimen Retention:   Samples With DNA
Tissue and blood specimens


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
primary care clinic
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02222753


Contacts
Layout table for location contacts
Contact: Long Cui, M.D. longcuidr@126.com

Locations
Layout table for location information
China, Shanghai
Shanghai Jiaotong University Recruiting
Shanghai, Shanghai, China, 200240
Contact: Long Cui, M.D.       longcuidr@126.com   
Principal Investigator: Long Cui, M.D.         
Sponsors and Collaborators
State Key Laboratory of Cancer Biology
Shanghai Jiao Tong University School of Medicine
Fourth Military Medical University
Second Military Medical University
China-Japan Friendship Hospital
Chinese Academy of Medical Sciences
Beijing Cancer Hospital
Chinese PLA General Hospital
Investigators
Layout table for investigator information
Study Chair: Long Cui, M.D. Shanghai Jiao Tong University School of Medicine

Layout table for additonal information
Responsible Party: Dake Chu, Dr., State Key Laboratory of Cancer Biology
ClinicalTrials.gov Identifier: NCT02222753     History of Changes
Other Study ID Numbers: 2014AA020801
First Posted: August 21, 2014    Key Record Dates
Last Update Posted: August 21, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Layout table for MeSH terms
Immunologic Factors
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Physiological Effects of Drugs