Colorectal Neuroendocrine Carcinomas (CRNEC); Genomic Landscape; Genetic Landscape; Prognosis; CCL5; PAX5NCT05714722
Epiction of the Genomic and Genetic Landscape Identifies CCL5 as a Protective Factor in Colorectal Neuroendocrine Carcinoma
An observational study of Colorectal Neuroendocrine Carcinomas (CRNEC); Genomic Landscape; Genetic Landscape; Prognosis; CCL5; PAX5, run by Zhejiang University.
Trial summary
Background: Colorectal neuroendocrine carcinomas (CRNECs) are highly aggressive tumours with poor prognosis and low incidence. To date, the genomic landscape and molecular pathway alterations have not been elucidated. Methods: Tissue sections and clinical information were collected as an in-house cohort (2010-2020). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Neuroendocrine Carcinomas (CRNEC); Genomic Landscape; Genetic Landscape; Prognosis; CCL5; PAX5
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Asia
Who may be able to join
- tissues from colorectal neuroendocrine carcinomas
Who cannot join
- no
About this study
Background: Colorectal neuroendocrine carcinomas (CRNECs) are highly aggressive tumours with poor prognosis and low incidence. To date, the genomic landscape and molecular pathway alterations have not been elucidated.
Methods: Tissue sections and clinical information were collected as an in-house cohort (2010-2020). Large-scale genomic and genetic panels were applied to identify the genomic and genetic alterations of CRNEC. Through the depiction of the genomic landscape and transcriptome profile, we compared the difference between CRNEC and CR neuroendocrine tumours (CRNETs). Immunohistochemistry (IHC) staining and immunofluorescence (IF) staining were performed to confirm the genetic alterations.
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 2010-2020
Secondary outcomes (1)
Comprehensive genomic and expression panels (AmoyDx® Master Panel) for dna and rna detection
Measured: 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Jan 2011
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Neuroendocrine Carcinomas (CRNEC); Genomic Landscape; Genetic Landscape; Prognosis; CCL5; PAX5Studies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijia Fang, MD, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714722
- Sponsor's protocol ID
- WFang
- Status last verified
- Feb 2024
- First submitted
- 27 Jan 2023
- Last updated
- 12 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epiction of the Genomic and Genetic Landscape Identifies CCL5 as a Protective Factor in Colorectal Neuroendocrine Carcinoma
- ClinicalTrials.gov ID
- NCT05714722
- Acronym / sponsor ID
- WFang
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 6 Feb 2023 (actual)
- 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.
Background: Colorectal neuroendocrine carcinomas (CRNECs) are highly aggressive tumours with poor prognosis and low incidence. To date, the genomic landscape and molecular pathway alterations have not been elucidated.
Methods: Tissue sections and clinical information were collected as an in-house cohort (2010-2020). Large-scale genomic and genetic panels were applied to identify the genomic and genetic alterations of CRNEC. Through the depiction of the genomic landscape and transcriptome profile, we compared the difference between CRNEC and CR neuroendocrine tumours (CRNETs). Immunohistochemistry (IHC) staining and immunofluorescence (IF) staining were performed to confirm the genetic alterations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asia
Key inclusion criteria (1 listed)
- tissues from colorectal neuroendocrine carcinomas
Key exclusion criteria (1 listed)
- no
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
overall survival
Time frame: 2010-2020
1 secondary outcome
Comprehensive genomic and expression panels (AmoyDx® Master Panel) for dna and rna detection
Time frame: 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neuroendocrine Carcinomas (CRNEC); Genomic Landscape; Genetic Landscape; Prognosis; CCL5; PAX5, run by Zhejiang University.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 2010-2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2024.