T4 Colorectal CancerNCT06958926
A Translational Study for Locoregional Recurrence of T4 Colon Cancer
An observational study of T4 Colorectal Cancer and Colorectal Cancer Stage III, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The outcome of T4 locally advanced colon cancer is poor when locoregional recurrence occurred. Previous studies had showed that the aggravation of T4 colon cancer is higher than N-positive colon cancer, contributing to staging paradox that outcomes of stage IIB/C are poorer than stage IIIA colon cancer and higher… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T4 Colorectal Cancer, Colorectal Cancer Stage III, Colorectal Cancer Stage II
- What is being tested?
- Radical surgery for colon and rectum cancer and Radical surgery for colorectal cancer
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 May 2025to 31 Dec 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected cT4 or pT4 colorectal cancer
Who may be able to join
- Age ≥ 18 years old
- Diagnosed as colorectal cancer
- Undergo radical colectomy or palliative colectomy, not limited to minimally invasive surgery or open surgery
Who cannot join
- Age<18 years old
- Pregnancy
- Patients with peritoneal dialysis
- Patients who are unwilling to undergo colorectal surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Hsin-Chu branch
Hsinchu, 308
Yu-Tso Liao, MD, PhD, +886972654554, G02386@hch.gov.tw
About this study
The outcome of T4 locally advanced colon cancer is poor when locoregional recurrence occurred. Previous studies had showed that the aggravation of T4 colon cancer is higher than N-positive colon cancer, contributing to staging paradox that outcomes of stage IIB/C are poorer than stage IIIA colon cancer and higher locoregional recurrence of stage IIB/C colon cancer. The phenomenon cannot be explained by radicality, lymph node harvested and adjuvant chemotherapy administration. To elucidate the cancerous aggravation of T4 colon cancer, the investigators should dive into the clinicopathology, metastatic mechanism and cancer biology.
The investigators hypothesize that peritoneal spreading can be one of the metastatic routes of T4 colon cancer; however, few studies have addressed the finding and deserved investigation. Previous research have found that serum epigenetic alterations and cell-free DNA can serve as a prognostic marker for stage II/III colon cancer.
Therefore, the aim of this study is (1) to explore the role of ascites cfDNA as a potential biomolecular marker for locoregional recurrence; (2) to identify the risk factors of locoregional recurrence for T4 colon cancer by correlating biomolecular markers between clinicopathology, epigenomic alterations in blood and ascites.
- Being tested
- Radical surgery for colon and rectum cancer, Radical surgery for colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical surgery for colon and rectum cancerProcedure or surgery
Radical surgery for colon and rectum cancer indicates that the surgery intends to eradicate all identifiable tumor in the human body.
Radical surgery for colorectal cancerProcedure or surgery
Radical surgery for colorectal cancer indicates that the surgery intends to eradicate all identifiable tumor in the human body.
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation the cell-free DNA level and sequencing between ascites and serum
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start14 May 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T4 Colorectal CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Tso Liao, MD, PhD, Principal investigator, National Taiwan University Hospital Hsin-Chu BranchYu-Tso Liao, Principal investigator, National Taiwan University Hospital Hsin-Chu Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958926
- Sponsor's protocol ID
- 202407175RINC
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- 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 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Translational Study for Locoregional Recurrence of T4 Colon Cancer
- ClinicalTrials.gov ID
- NCT06958926
- Acronym / sponsor ID
- 202407175RINC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 14 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 May 2025 (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 outcome of T4 locally advanced colon cancer is poor when locoregional recurrence occurred. Previous studies had showed that the aggravation of T4 colon cancer is higher than N-positive colon cancer, contributing to staging paradox that outcomes of stage IIB/C are poorer than stage IIIA colon cancer and higher locoregional recurrence of stage IIB/C colon cancer. The phenomenon cannot be explained by radicality, lymph node harvested and adjuvant chemotherapy administration. To elucidate the cancerous aggravation of T4 colon cancer, the investigators should dive into the clinicopathology, metastatic mechanism and cancer biology.
The investigators hypothesize that peritoneal spreading can be one of the metastatic routes of T4 colon cancer; however, few studies have addressed the finding and deserved investigation. Previous research have found that serum epigenetic alterations and cell-free DNA can serve as a prognostic marker for stage II/III colon cancer.
Therefore, the aim of this study is (1) to explore the role of ascites cfDNA as a potential biomolecular marker for locoregional recurrence; (2) to identify the risk factors of locoregional recurrence for T4 colon cancer by correlating biomolecular markers between clinicopathology, epigenomic alterations in blood and ascites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected cT4 or pT4 colorectal cancer
Key inclusion criteria (3 listed)
Key exclusion criteria (4 listed)
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 |
|---|---|---|
| Radical surgery for colon and rectum cancerRadical surgery for colon and rectum cancer indicates that the surgery intends to eradicate all identifiable tumor in the human body. | Procedure or surgery | – |
| Radical surgery for colorectal cancerRadical surgery for colorectal cancer indicates that the surgery intends to eradicate all identifiable tumor in the human body. | Procedure or surgery | – |
Primary outcome
The correlation the cell-free DNA level and sequencing between ascites and serum
Time frame: One year
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 25 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for T4 Colorectal Cancer
Active, not recruitingPhase 2
Neoadjuvant Immunotherapy for T4 dMMR Colon Cancer
Colon Cancer, Mismatch Repair Deficiency
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.
Yu-Tso Liao, MD, PhD principal investigator
National Taiwan University Hospital Hsin-Chu Branch
Yu-Tso Liao principal investigator
National Taiwan University Hospital Hsin-Chu Branch
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 T4 Colorectal Cancer and Colorectal Cancer Stage III, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 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 25 May 2025. 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 Taiwan. 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 Yu-Tso Liao, MD, PhD (886-3667-7600 ext. 1971, G02386@hch.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation the cell-free DNA level and sequencing between ascites and serum (time frame: One year). 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 25 May 2025.