Colorectal CancerNCT05482529
Integrative Omics Analysis for Colorectal Cancer and Metastasis
An observational study of Colorectal Cancer, run by fan li at 1 site in China.
Trial summary
The pathogenesis of Colorectal cancer (CRC) metastasis remains unclear.We collect clinical data from our center and use Integrative omics to analyze and predict candidate biomarkers of colorectal cancer and distant metastasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Integrative omics
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Dec 2025
- How long will I take part?
- 24 Months
- 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 years and older
- All sexes
- Adult, Older adult
Study population: All patients with colorectal cancer and metastasis will be enrolled.
Who may be able to join
- colorectal adenocarcinoma by biopsy。
- at least 1 metastasis lesion comfirmed by at least 1 kind of imaging examination (CT, MRI and PET-CT )
Who cannot join
- recent diagnosis with other malignancies
- can not tolerate the surgery
- history of serious mental illness
- pregnancy or lactating women
- the researchers believe the patients should not enrolled in
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Daping hospital
Chongqing, 400042
fan Li, PhD, 68729350, levinecq@163.com
About this study
Official title: A Prospective Study of Integrative Omics Analysis for Colorectal Cancer and Metastasis
The pathogenesis of Colorectal cancer (CRC) metastasis remains unclear.We collect clinical data from our center and use Integrative omics to analyze and predict candidate biomarkers of colorectal cancer and distant metastasis.
Read the detailed description
Colorectal cancer (CRC), one of the most common malignant cancer around the world, CRC patients with distant metastasis. However, the pathogenesis of metastasis remains unclear. Integrative omics have begun to enable personalized medicine at an extraordinarily detailed molecular level. All patients with colorectal cancer and metastasis in our center who meet the inclusion criteria and exclusion criteria will be enrolled. The specimen collected by surgery and clinical data will be collected . We use Integrative omics such as RNA-sequencing,ATAC-seq(Assay for Transposase-Accessible Chromatin using sequencing), CUT\&Tag（ Cleavage Under Targets and Tagmentation）to analyze and predict candidate biomarkers of colorectal cancer and distant metastasis. This study will contribute to understanding the molecular mechanism of CRC metastasis in depth and contribute to the discovery of new appropriate molecular diagnostic and therapeutic targets, and more accurately prognose long term outcome in patients with CRC.
- Conditions
- Colorectal Cancer
- Being tested
- Integrative omics
- Keywords
- Integrative omics, colorectal cancer, distant metastasis, prognostic analysis
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative omicsOther
Integrative omics such as RNA-sequencing,ATAC-seq(Assay for Transposase-Accessible Chromatin using sequencing), CUT\&Tag（ Cleavage Under Targets and Tagmentation）to analyze and predict candidate biomarkers of colorectal cancer and distant metastasis.
| Study group | Role | What they receive |
|---|---|---|
| colorectal cancer with metastasis | colorectal cancer patients with at least one distant metastasis(liver, lung) Receives: Other: Integrative omics |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival rate
the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
Measured: 3 years after surgery
disease free survival rate
the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
Measured: 3 years after surgery
Secondary outcomes (3)
Quality of life outcomes evaluation(QLQ-CR38)
We examine before operation, 3 months after, 6 months after, 12 months after, 24 months after operation, by questionnaires (HRQoL).The General quality of life quality of life Questionnaires of Colorectal Cancer-38(QLQ-CR38) are used to evaluate the Quality of life outcomes. Items are scored on a four-point scale from 1("not at all) to 4 ("very much"). Raw scores are aggregated and converted to a linear scale ranging from 0 to 100, with higher scores representing a higher level of functioning or a higher level of symptoms
Measured: 0- 2 years after surgery
Quality of life outcomes evaluation(QLQ-C30)
We examine before operation, 3 months after, 6 months after, 12 months after, 24 months after operation, by questionnaires (HRQoL).The General quality of life Quality of life Questionnaires of Cancer-30 (QLQ-C30) are used to evaluate the Quality of life outcomes. Items are scored on a four-point scale from 1("not at all) to 4 ("very much"). Raw scores are aggregated and converted to a linear scale ranging from 0 to 100, with higher scores representing a higher level of functioning or a higher level of symptoms
Measured: 0- 2 years after surgery
R0 resection rate
The R0 resection rate by pathology outcome of specimen
Measured: 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Aug 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- fan li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, fan li, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482529
- Sponsor's protocol ID
- IOACCM
- Status last verified
- Jul 2022
- First submitted
- 4 May 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Integrative Omics Analysis for Colorectal Cancer and Metastasis
- ClinicalTrials.gov ID
- NCT05482529
- Acronym / sponsor ID
- IOACCM
- Conditions
- Colorectal Cancer
- Keywords
- Integrative omics, colorectal cancer, distant metastasis, prognostic analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- fan liUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Aug 2022 (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.
The pathogenesis of Colorectal cancer (CRC) metastasis remains unclear.We collect clinical data from our center and use Integrative omics to analyze and predict candidate biomarkers of colorectal cancer and distant metastasis.
Detailed description
Colorectal cancer (CRC), one of the most common malignant cancer around the world, CRC patients with distant metastasis. However, the pathogenesis of metastasis remains unclear. Integrative omics have begun to enable personalized medicine at an extraordinarily detailed molecular level. All patients with colorectal cancer and metastasis in our center who meet the inclusion criteria and exclusion criteria will be enrolled. The specimen collected by surgery and clinical data will be collected . We use Integrative omics such as RNA-sequencing,ATAC-seq(Assay for Transposase-Accessible Chromatin using sequencing), CUT\&Tag（ Cleavage Under Targets and Tagmentation）to analyze and predict candidate biomarkers of colorectal cancer and distant metastasis. This study will contribute to understanding the molecular mechanism of CRC metastasis in depth and contribute to the discovery of new appropriate molecular diagnostic and therapeutic targets, and more accurately prognose long term outcome in patients with CRC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| colorectal cancer with metastasis | – | Other: Integrative omicscolorectal cancer patients with at least one distant metastasis(liver, lung) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients with colorectal cancer and metastasis will be enrolled.
Key inclusion criteria (2 listed)
- colorectal adenocarcinoma by biopsy。
- at least 1 metastasis lesion comfirmed by at least 1 kind of imaging examination (CT, MRI and PET-CT )
Key exclusion criteria (5 listed)
- recent diagnosis with other malignancies
- can not tolerate the surgery
- history of serious mental illness
- pregnancy or lactating women
- the researchers believe the patients should not enrolled in
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 |
|---|---|---|
| Integrative omicsIntegrative omics such as RNA-sequencing,ATAC-seq(Assay for Transposase-Accessible Chromatin using sequencing), CUT\&Tag（ Cleavage Under Targets and Tagmentation）to analyze and predict candidate biomarkers of colorectal cancer and distant metastasis. | Other | colorectal cancer with metastasis |
Primary outcome
overall survival rate
Time frame: 3 years after surgery
the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
disease free survival rate
Time frame: 3 years after surgery
the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
3 secondary outcomes
Quality of life outcomes evaluation(QLQ-CR38)
Time frame: 0- 2 years after surgery
Quality of life outcomes evaluation(QLQ-C30)
Time frame: 0- 2 years after surgery
R0 resection rate
Time frame: 2 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by fan li at 1 site 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact fan li, MD (86 023 68757958, levinecq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival rate (time frame: 3 years after surgery). The study lists 2 primary outcomes in all. 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 1 Aug 2022.