NCT03334890

Brief Summary

The surgical therapeutic effect of stage II-IV CRC patients will be assessed by the plasma mSEPT9 assay, and patients will be followed up by the same assay for recurrence monitoring.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

4 active sites

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

January 1, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

2 years

First QC Date

November 3, 2017

Last Update Submit

November 6, 2017

Conditions

Colorectal Cancer

Keywords

colorectal cancerseptin 9SEPT9methylationCEA

Outcome Measures

Primary Outcomes (1)

  • mSEPT9 level

    the Ct values representing the mSEPT9 level in plasma

    Jan 1, 2016 to Dec 31, 2017

Secondary Outcomes (3)

  • CEA level

    Jan 1, 2016 to Dec 31, 2017

  • tumor size

    Jan 1, 2016 to Dec 31, 2017

  • CR,PR,SD,PD

    Jan 1, 2016 to Dec 31, 2017

Interventions

plasma mSEPT9 levelDIAGNOSTIC_TEST

the plasma level of methylated SEPT9

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

stage II-IV CRC patients planning to performe surgery

You may qualify if:

  • stage II-IV CRC patients planning to perform surgery

You may not qualify if:

  • stage 0-I CRC patients, patients with history of CRC or other cancers, patients not suitable for surgery, pregnant women, patients younger than 30 or older than 80.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The Chinese PLA 302th hospital

Beijing, China

RECRUITING

The Chinese PLA 309th hospital

Beijing, China

RECRUITING

The Chinese PLA general hospital

Beijing, China

RECRUITING

The first affiliated hospital of the Chinese PLA general hospital

Beijing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

plasma samples from CRC patients before surgery, one day and seven days after surgery

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Lele Song, M.D.,Ph.D.

    The Chinese PLA 309th Hospital

    STUDY DIRECTOR

Central Study Contacts

Lele Song, M.D.,Ph.D.

CONTACT

86-13240149188songlele@sina.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 3, 2017

First Posted

November 7, 2017

Study Start

January 1, 2016

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

November 7, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)