NCT01911988

Brief Summary

The purpose of this study is to determine association between Peripheral Immune Cells(PIC) and recurrence in stage II/III colorectal cancer

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Last Updated

October 20, 2016

Status Verified

October 1, 2016

Enrollment Period

7.5 years

First QC Date

July 23, 2013

Last Update Submit

October 19, 2016

Conditions

Colorectal Cancer

Keywords

Peripheral immune cellsColorectal CancersStage II/ Stage IIIRecurrenceMetastasis

Outcome Measures

Primary Outcomes (1)

  • Disease Free Survival

    The time from resection to the time of disease recurrence(local or metastatic) or death from any cause.

    5 years

Secondary Outcomes (1)

  • 5 years overall survival

    5 years or the time of death

Study Arms (1)

Colon&Rectal Stage II /Stage III

Eligibility Criteria

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

Stage II /Stage III Colorectal Patients

You may qualify if:

  • Clinically /Pahohistologically diagnosed as stageII/III CRC
  • ECOG 0-2
  • Age 18-90
  • Gender both

You may not qualify if:

  • Distant metastases noticed before or during surgery
  • History of malignant tumor disease
  • History of autoimmune diseases or immunodeficiencies
  • History of hematological disease
  • History of hepatic cirrhosis or Splenomegaly
  • History of chronic kidney disease
  • History of organ transplant
  • History of chronic inflammatory disease
  • Use of hematological drugs within 1 year prior to surgery
  • Use of immunodulatory drugs within 1 year prior to surgery
  • Use of chemotherapeutic drugs within 1 year prior to surgery
  • Long term Use of non-steroid anti-inflammatory drugs(\>6 months)
  • Unable or Unwilling to undergo all the standard treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Center of Colon&Rectal Cancers

Shanghai, 2000092, China

Location

MeSH Terms

Conditions

Colorectal NeoplasmsRecurrenceNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplastic Processes

Study Officials

  • Long Cui, MD, PhD

    Medical Center of Colon&Rectal Cancers, Shanghai Xinhua Hospital affiliated to Shanghai Jiaotong University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 23, 2013

First Posted

July 30, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2020

Last Updated

October 20, 2016

Record last verified: 2016-10

Locations

CN(1)