NCT01828918

Brief Summary

Recent basic and clinical research on the circulating tumor cells (CTCs) in CRC patients takes potential diagnostics, prognostics, and applications into consideration, especially the molecular detection of CTCs in peripheral blood. Moreover, identification of therapeutic targets on CTCs and real-time monitoring of CTCs in cancer patients undergoing systemic therapy are the most important future clinical applications. CTCs measures may be useful to guide change in treatment decisions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_1

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, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 11, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 11, 2013

Status Verified

June 1, 2012

Enrollment Period

4.5 years

First QC Date

January 27, 2013

Last Update Submit

April 10, 2013

Conditions

Colorectal Cancers

Keywords

early diagnosispredictionprognosis

Outcome Measures

Primary Outcomes (1)

  • postoperative early recurrence

    within 12 months postoperation

Study Arms (1)

early recurrence

OTHER

find the postoperative early relapse out

Genetic: microRNAs

Interventions

microRNAsGENETIC
early recurrence

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 y/o
  • Histological / pathologic and image study proved colorectal cancer
  • Patients with adequate tissue for biomarkers analysis
  • Patients voluntary sign informed consent

You may not qualify if:

  • Patients who are not met with either one of items which mentioned above.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, Kaohsiung, 807, Taiwan

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsDisease

Interventions

MicroRNAs

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RNA, AntisenseAntisense Elements (Genetics)Nucleic Acids, Nucleotides, and NucleosidesRNANucleic AcidsRNA, Small UntranslatedRNA, Untranslated

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2013

First Posted

April 11, 2013

Study Start

June 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 11, 2013

Record last verified: 2012-06

Locations

TW(1)