NCT02222753

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Last Updated

August 21, 2014

Status Verified

August 1, 2014

Enrollment Period

4.9 years

First QC Date

August 20, 2014

Last Update Submit

August 20, 2014

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Overall survival

    5 years

Other Outcomes (1)

  • Disease-free survival

    5 years

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

primary care clinic

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200240, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue and blood specimens

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Long Cui, M.D.

    Shanghai Jiao Tong University School of Medicine

    STUDY CHAIR

Central Study Contacts

Long Cui, M.D.

CONTACT

longcuidr@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 20, 2014

First Posted

August 21, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2018

Last Updated

August 21, 2014

Record last verified: 2014-08

Locations

CN(1)