NCT02540850

Brief Summary

The purpose of this study is to evaluate the performance of the SEPT9 gene methylation assay in Colorectal cancer (CRC) high-risk population in Chinese hospitals using the opportunistic screening method. The trial plans to evaluate a Chinese domestic SEPT9 assay kit produced by BioChain (Beijing) Science and Technology Corporation, who is a close partner of Epigenomics AG, the producer for Epi proColon 2.0 CE.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,031

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

4 active sites

Status
completed

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

February 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2015

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
3 months until next milestone

Results Posted

Study results publicly available

January 11, 2016

Completed
Last Updated

January 11, 2016

Status Verified

January 1, 2016

Enrollment Period

1.6 years

First QC Date

August 12, 2015

Results QC Date

October 13, 2015

Last Update Submit

January 7, 2016

Conditions

Colorectal CancerAdenomatous Polyp of ColonPolypsOther Disease/InjuryOther Cancers

Keywords

septin 9SEPT9colorectal cancerCRCscreeningmethylationadenomapolypsFITFOBTcolonoscopy

Outcome Measures

Primary Outcomes (1)

  • Ct Value (Ct Values From PCR Reaction)

    the number of PCR cycles where the amplification signal starts to be observed

    1 year

Secondary Outcomes (6)

  • Sensitivity (Sensitivity of mSEPT9 Assay in Detecting Colorectal Cancer)

    1 year

  • Specificity (Specificity of mSEPT9 Assay in Non-CRC Diseases and NED (no Evidence of Diseases))

    1 year

  • PPV (the Positive Predictive Value of mSEPT9 Assay in the Population)

    1 year

  • NPV (the Negative Predictive Value of mSEPT9 Assay in the Population)

    1 year

  • Positivity Rate (The Ratio of Positive mSEPT9 Results in the Population)

    1 year

  • +1 more secondary outcomes

Study Arms (3)

CRC group

stage 0-IV CRC subjects

precancerous disease group

subjects with adenoma or polyps

other disease group

subjects with other bowel diseases, other cancers, and subjects with no evidence of disease

Eligibility Criteria

Age17 Years - 88 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All eligible inpatients, outpatients, and subjects from health examination centers.

You may qualify if:

  • sample information is complete, including sample number, gender, age and clinical diagnosis;
  • CRC group: positive samples refer to samples confirmed to be CRC with colonoscopy and/or pathological examination;
  • precancerous disease group: all samples confirmed to be adenoma and polyps by colonoscopy and/or pathological examination
  • other disease group: samples confirmed to be other GI diseases, other cancers or no evidence of diseases by colonoscopy and/or pathological examination

You may not qualify if:

  • the patient information is not complete;
  • the sample information is not complete;
  • history of colorectal cancer surgery or other cancer history, or any chemotherapy;
  • women in pregnancy;
  • samples not comply with any of the above selection criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Beijing Cancer Hospital

Beijing, China

Location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

General Hospital of Beijing PLA Military Region

Beijing, China

Location

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Conditions

Colorectal NeoplasmsPolypsDiseaseWounds and InjuriesAdenoma

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPathologic ProcessesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Results Point of Contact

Title
Dr. Lele Song
Organization
BioChain (Beijing) Science and Technology, Inc.
songlele@biochainbj.com
86-10-63401580

Study Officials

  • XIAOLIANG HAN, Ph.D.

    BioChain (Beijing) Science and Technology, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2015

First Posted

September 4, 2015

Study Start

February 1, 2014

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

January 11, 2016

Results First Posted

January 11, 2016

Record last verified: 2016-01

Locations

CN(4)