Tumor Associated NeutrophilsNCT06495827
Predicting Response to Chemotherapy in Colorectal Cancer Via Multi-dimensional Analyses of the Tumor Associated Neutrophils
An observational study of Tumor Associated Neutrophils, run by Fudan University.
Trial summary
A single biomarker is not adequate to identify patients with colorectal cancer (CRC) who have the potential to benefit from adjuvant therapy, presumably owing to the complexity of tumor-infiltrating immune cells (TIICs). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tumor Associated Neutrophils
- What is being tested?
- No different intenvention
- How many people
- 653 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Aug 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study enrolled multiple cohorts, consisting of 653 tumor microarray specimens of CRC patients from Zhongshan Hospital
Who may be able to join
- Voluntarily sign a written ICF.
- The Eastern Cancer Collaborative Organization (ECOG) has a physical fitness score of 0 or 1.
- The expected survival period is ≥ 3 months.
- 5. Subjects diagnosed with metastatic colorectal adenocarcinoma by histology or cytology.
- 6. Colorectal cancer patients who have not received systematic anti-tumor therapy in the past.
Who cannot join
- Subjects suffered from other malignant tumors within 3 years before enrollment, except for cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, etc.).
- Simultaneously enroll in another clinical study, unless it is an observational, non-interference clinical study or a follow-up period of an intervention study.
- Received systematic anti-tumor therapy (chemotherapy) within 3 weeks prior to the first administration
About this study
Official title: Zhongshan Hospital，Fudan University
A single biomarker is not adequate to identify patients with colorectal cancer (CRC) who have the potential to benefit from adjuvant therapy, presumably owing to the complexity of tumor-infiltrating immune cells (TIICs). The density and spatial organization of TIICs has not been definitely established to explore their predictive value. This study aimed to investigate the prognostic significance of TIICs and its biological predictive value in CRC.
- Conditions
- Tumor Associated Neutrophils
- Being tested
- No different intenvention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No different intenventionOther
No different intenvention
| Study group | Role | What they receive |
|---|---|---|
| response cohort | CRC patients with response status after chemotherapy Receives: Other: No different intenvention | |
| resistance cohort | CRC patients with resistance status after chemotherapy Receives: Other: No different intenvention |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Measured: From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study startJul 2010
- Primary completionJul 2020
- Study completionAug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor Associated NeutrophilsStudies of the same condition, open and under way.
- More trials run by Fudan 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
- 653 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianmin, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495827
- Sponsor's protocol ID
- TANs for CT response in CRC
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zhongshan Hospital，Fudan University
- ClinicalTrials.gov ID
- NCT06495827
- Acronym / sponsor ID
- TANs for CT response in CRC
- Conditions
- Tumor Associated Neutrophils
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 653 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jul 2010 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Aug 2023 (actual)
- First posted
- 11 Jul 2024 (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.
A single biomarker is not adequate to identify patients with colorectal cancer (CRC) who have the potential to benefit from adjuvant therapy, presumably owing to the complexity of tumor-infiltrating immune cells (TIICs). The density and spatial organization of TIICs has not been definitely established to explore their predictive value. This study aimed to investigate the prognostic significance of TIICs and its biological predictive value in CRC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| response cohort | – | Other: No different intenventionCRC patients with response status after chemotherapy |
| resistance cohort | – | Other: No different intenventionCRC patients with resistance status after chemotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study enrolled multiple cohorts, consisting of 653 tumor microarray specimens of CRC patients from Zhongshan Hospital
Key inclusion criteria (5 listed)
- Voluntarily sign a written ICF.
- The Eastern Cancer Collaborative Organization (ECOG) has a physical fitness score of 0 or 1.
- The expected survival period is ≥ 3 months.
- 5. Subjects diagnosed with metastatic colorectal adenocarcinoma by histology or cytology.
- 6. Colorectal cancer patients who have not received systematic anti-tumor therapy in the past.
Key exclusion criteria (3 listed)
- Subjects suffered from other malignant tumors within 3 years before enrollment, except for cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, etc.).
- Simultaneously enroll in another clinical study, unless it is an observational, non-interference clinical study or a follow-up period of an intervention study.
- Received systematic anti-tumor therapy (chemotherapy) within 3 weeks prior to the first administration
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 |
|---|---|---|
| No different intenventionNo different intenvention | Other | resistance cohort, response cohort |
Primary outcome
PFS
Time frame: From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
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 11 Jul 2024.
- Individual participant dataSharing planned: No
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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.
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 Tumor Associated Neutrophils, run by Fudan 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 5 inclusion and 3 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 11 Jul 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?
PFS (time frame: From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months). 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 11 Jul 2024.