NCT02917707

Brief Summary

The investigators will perform integrative analysis of CRC liver metastasis

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress96%
Jan 2016Dec 2026

Study Start

First participant enrolled

January 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 28, 2016

Status Verified

September 1, 2016

Enrollment Period

10.9 years

First QC Date

September 26, 2016

Last Update Submit

September 27, 2016

Conditions

Metastasis

Keywords

CRCliver metastasis

Outcome Measures

Primary Outcomes (1)

  • 5 years overall survival

    5 years

Secondary Outcomes (1)

  • 5 years disease-free survival

    5 years

Study Arms (3)

normal colorectal tissues (PN)

normal colorectal tissues

Other: normal colorectal tissues

primary colorectal carcinoma tissues

primary colorectal carcinoma tissues

Other: normal colorectal tissues

liver metastasis tissues

liver metastasis tissues

Other: normal colorectal tissues

Interventions

normal colorectal tissuesOTHER

The investigators will extract total protein, DNA and RNA from these groups.

Also known as: primary colorectal carcinoma tissues, liver metastasis tissues
liver metastasis tissuesnormal colorectal tissues (PN)primary colorectal carcinoma tissues

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with CRC

You may qualify if:

  • Age ≤ 75 years with histologically proven CRC
  • No severe major organ dysfunction
  • WHO performance status of 0 or 1
  • No prior cancer chemotherapy

You may not qualify if:

  • Age ≥ 76
  • Severe major organ dysfunction
  • World Health Organization (WHO) performance status of \>1
  • Prior cancer chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ganzhou City People's Hospital

Ganzhou, Jiangxi, 341000, China

RECRUITING

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

Related Publications (2)

  • Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.

    PMID: 25651787RESULT

  • Ma YS, Huang T, Zhong XM, Zhang HW, Cong XL, Xu H, Lu GX, Yu F, Xue SB, Lv ZW, Fu D. Proteogenomic characterization and comprehensive integrative genomic analysis of human colorectal cancer liver metastasis. Mol Cancer. 2018 Sep 21;17(1):139. doi: 10.1186/s12943-018-0890-1.

    PMID: 30241526DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Da Fu, Ph.D.

    the Shanghai Tenth People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Da Fu, Ph.D.

CONTACT

021-66301604shsyiec@126.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 26, 2016

First Posted

September 28, 2016

Study Start

January 1, 2016

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 28, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

The investigators are willing to share data.

Locations

CN(2)