Integrative Analysis of CRC Liver Metastasis

Metastasis Clinical Trial

— CRC-LM  

Official title:

Integrative Analysis of CRC Liver Metastasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02917707
• Other study ID #: Y219J11311
• Status: Recruiting
• Phase: N/A
• First received: September 26, 2016
• Last updated: September 27, 2016
• Start date: January 2016
• Est. completion date: December 2026

Study information

• Verified date: September 2016
• Source: Shanghai 10th People's Hospital
• Contact: Da Fu, Ph.D.
• Phone: 021-66301604
• Email: shsyiec[@]126.com
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Observational

Clinical Trial Summary

The investigators will perform integrative analysis of CRC liver metastasis

Description:

The investigators will analyzed proteomes of paired normal colorectal tissues and colorectal cancer (CRC) with or without liver metastasis, sequenced transcriptomes, performed whole exome sequencing, and single nucleotide polymorphism (SNP) array profiling for triplets, each comprising normal colorectal tissue, primary colorectal carcinoma, and its synchronous matched liver metastasis, as well as analyzed genomics of CRC characterized previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age = 75 years with histologically proven CRC

• No severe major organ dysfunction

• WHO performance status of 0 or 1

• No prior cancer chemotherapy

Exclusion Criteria:

• Age = 76

• Severe major organ dysfunction

• World Health Organization (WHO) performance status of >1

• Prior cancer chemotherapy

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Metastasis
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Other:
• normal colorectal tissues
The investigators will extract total protein, DNA and RNA from these groups.

Locations

Country	Name	City	State
China	Ganzhou City People's Hospital	Ganzhou	Jiangxi
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Da Fu	Ganzhou City People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5 years overall survival		5 years	Yes
Secondary	5 years disease-free survival		5 years	Yes