Immunological Markers Screening for Colorectal Cancer | NCT02222753

Studies
Immunological Markers Screening for Colorectal Cancer

NCT02222753

Sponsor

State Key Laboratory of Cancer Biology

Status

Unknown status

Last Update Posted

Aug 21, 2014Estimated

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Colorectal Cancer

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Dec 2018Estimated

Completion Date

Not provided

First Submitted Date

Aug 20, 2014

First Submission Date that Met QC Criteria

Aug 20, 2014

First Posted Date

Aug 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2014

Last Update Posted Date

Aug 21, 2014Estimated

Name	Class
Shanghai Jiao Tong University School of Medicine	OTHER
Air Force Military Medical University, China	OTHER
Second Military Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

5,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Overall survival	Overall survival is defined as the time elapsed from surgery to the date of death from any cause.	5 years

Other Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

primary care clinic

Sampling Method

Probability Sample

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site