MetastasisCRC-LMNCT02917707
Integrative Analysis of CRC Liver Metastasis
An observational study of Metastasis, run by Da Fu at 2 sites in China.
Trial summary
The investigators will perform integrative analysis of CRC liver metastasis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastasis
- What is being tested?
- normal colorectal tissues
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2016to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with CRC
Who may be able to join
- Age ≤ 75 years with histologically proven CRC
- No severe major organ dysfunction
- WHO performance status of 0 or 1
- No prior cancer chemotherapy
Who cannot join
- Age ≥ 76
- Severe major organ dysfunction
- World Health Organization (WHO) performance status of >1
- Prior cancer chemotherapy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Ganzhou City People's Hospital
Ganzhou, Jiangxi, 341000
Xiaoming Zhong, MD, 00-86-797-8356156, 15979192617@163.com
Xiaoming Zhong, MD
- Recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Da Fu, Ph.D., 00-86-21-66301604, fu800da900@126.com
Yushui Ma, Ph.D.
About this study
The investigators will perform integrative analysis of CRC liver metastasis
Read the detailed 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.
- Conditions
- Metastasis
- Being tested
- normal colorectal tissues
- Keywords
- CRC, liver metastasis
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal colorectal tissuesOther
Also called primary colorectal carcinoma tissues, liver metastasis tissues
The investigators will extract total protein, DNA and RNA from these groups.
| Study group | Role | What they receive |
|---|---|---|
| normal colorectal tissues (PN) | normal colorectal tissues Receives: Other: normal colorectal tissues | |
| primary colorectal carcinoma tissues | primary colorectal carcinoma tissues Receives: Other: normal colorectal tissues | |
| liver metastasis tissues | liver metastasis tissues Receives: Other: normal colorectal tissues |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 years overall survival
Measured: 5 years
Secondary outcomes (1)
5 years disease-free survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Da Fu
- Sponsor type
- University, hospital or other
- Collaborators
- Ganzhou City People's Hospital
- Responsible party
- Sponsor-investigator, Da Fu, Shanghai 10th People's Hospital
- Investigators
- Da Fu, Ph.D., Principal investigator, the Shanghai Tenth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917707
- Sponsor's protocol ID
- Y219J11311
- Acronym
- CRC-LM
- Status last verified
- Sep 2016
- First submitted
- 26 Sep 2016
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The investigators are willing to share data.
Publications
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.
PubMed 25651787Ma 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.
PubMed 30241526
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Analysis of CRC Liver Metastasis
- ClinicalTrials.gov ID
- NCT02917707
- Acronym / sponsor ID
- CRC-LM / Y219J11311
- Conditions
- Metastasis
- Keywords
- CRC, liver metastasis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Da FuUniversity, hospital or other
- Collaborators
- Ganzhou City People's Hospital
- Study start
- Jan 2016
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will perform integrative analysis of CRC liver metastasis
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal colorectal tissues (PN) | – | Other: normal colorectal tissuesnormal colorectal tissues |
| primary colorectal carcinoma tissues | – | Other: normal colorectal tissuesprimary colorectal carcinoma tissues |
| liver metastasis tissues | – | Other: normal colorectal tissuesliver metastasis tissues |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with CRC
Key inclusion criteria (4 listed)
- Age ≤ 75 years with histologically proven CRC
- No severe major organ dysfunction
- WHO performance status of 0 or 1
- No prior cancer chemotherapy
Key exclusion criteria (4 listed)
- Age ≥ 76
- Severe major organ dysfunction
- World Health Organization (WHO) performance status of >1
- Prior cancer chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normal colorectal tissuesAlso: primary colorectal carcinoma tissues, liver metastasis tissuesThe investigators will extract total protein, DNA and RNA from these groups. | Other | liver metastasis tissues, normal colorectal tissues (PN), primary colorectal carcinoma tissues |
Primary outcome
5 years overall survival
Time frame: 5 years
1 secondary outcome
5 years disease-free survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
- Results publication: PubMed 25651787Torre 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.
- Derived from this study: PubMed 30241526Ma 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.
- Individual participant dataSharing planned: Yes. The investigators are willing to share data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Da Fu, Ph.D. principal investigator
the Shanghai Tenth People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastasis, run by Da Fu at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Da Fu, Ph.D. (021-66301604, shsyiec@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5 years overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02917707, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2016.