Rectal NeoplasmsNCT05109130
Change of Circulating Tumor Cells During Laparoscopic or Transanal Endoscopic Surgery for Rectal Cancer.
An observational study of Rectal Neoplasms and Neoplastic Cells, Circulating, run by Sun Yat-sen University at 1 site in China.
Trial summary
The primary purpose of this study is to compare the changes of circulating tumor cells (CTCs) at different time points in rectal cancer patients undergoing laparoscopic or transanal endoscopic radical resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms, Neoplastic Cells, Circulating, Laparoscopic Surgery
- What is being tested?
- Surgical approach
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2021to 18 Oct 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: 100 rectal cancer patients will be enrolled. Patients must be older than 18 years.
Who may be able to join
- Mid-low rectal cancer.
- Single lesion.
- No metastasis.
- Clinical Stage T2-3, N0-1.
Who cannot join
- History of malignant tumors.
- Acute bowel obstruction, bleeding or perforation.
- Received neoadjuvant treatment.
- Tumor over 6cm in diameter or in severe adhesion with surrounded tissues.
- Severe other contradictions of surgery.
- Pregnant women will be excluded.
Show all 9Show fewer
- Exit Criteria:
- The patient suffered from massive hemorrhage.
- The operation mode needs to be changed according to the patient's condition.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510655
About this study
Official title: Sixth Affiliated Hospital, Sun Yat-sen University
The primary purpose of this study is to compare the changes of circulating tumor cells (CTCs) at different time points in rectal cancer patients undergoing laparoscopic or transanal endoscopic radical resection. Our secondary purpose is to explore the effects of perioperative circulating tumor cells on tumor recurrence and metastasis.
Read the detailed description
Mid-low rectal cancer is one of the common malignant tumors and the incidence has increased significantly in recent years. At present, surgery is still the most important and effective method for the treatment of mid-low rectal cancer. Traditional laparoscopic surgery and emerging transanal total mesorectal excision (TaTME) are the main methods. More than one-third of rectal cancer patients will eventually occur local recurrence and distant metastasis, which are the most important factors affecting prognosis. Circulating tumor cells may lead to distant metastasis, so the detection of CTCs in blood has important clinical significance in predicting the recurrence and metastasis of rectal cancer and monitoring treatment response. Due to the different degrees of contact between distinct surgical methods, this may lead to an increase in the quantity of CTCs in the blood, which may affect the prognosis of patients. Therefore, the investigators conducted a randomized controlled study to compare the changes in the quantity of CTCs in the central vein before, during and after operation in rectal cancer patients undergoing transanal endoscopic or laparoscopic radical resection. To explore the effect of two surgical methods on the risk of micrometastasis, and to provide evidence for the selection and improvement of rectal cancer treatment.
- Conditions
- Rectal Neoplasms, Neoplastic Cells, Circulating, Laparoscopic Surgery, Transanal Endoscopic Surgery
- Being tested
- Surgical approach
- Keywords
- rectal cancer, CTCs
- Medical subject headings
- Rectal Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical approachProcedure or surgery
Different surgical methods for rectal cancer resection
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic surgery | Laparoscopic total mesorectal excision was performed on the enrolled patients. Receives: Procedure: Surgical approach | |
| Transanal endoscopic surgery | Transanal total mesorectal excision was performed on the enrolled patients. Receives: Procedure: Surgical approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of circulating tumor cells during laparoscopic or transanal endoscopic surgery
To determine the changes of circulating tumor cells in rectal cancer patients undergoing laparoscopic or transanal endoscopic radical resection before operation and 5 days after operation.
Measured: 1 years
Secondary outcomes (1)
Disease free survival
Determine relationship of CTC numbers and local recurrence and distant metastasis
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start18 Oct 2021
- Primary completion25 Oct 2022
- Study completion18 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
- Investigators
- Liang Huang, Principal investigator, Sun Yat-sen University Sixth Affiliated Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109130
- Sponsor's protocol ID
- GIHSYSU-20
- Status last verified
- Apr 2023
- First submitted
- 26 Oct 2021
- Last updated
- 13 Apr 2023
- 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 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sixth Affiliated Hospital, Sun Yat-sen University
- ClinicalTrials.gov ID
- NCT05109130
- Acronym / sponsor ID
- GIHSYSU-20
- Conditions
- Rectal Neoplasms, Neoplastic Cells, Circulating, Laparoscopic Surgery, Transanal Endoscopic Surgery
- Keywords
- rectal cancer, CTCs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 18 Oct 2025 (estimated)
- First posted
- 5 Nov 2021 (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 primary purpose of this study is to compare the changes of circulating tumor cells (CTCs) at different time points in rectal cancer patients undergoing laparoscopic or transanal endoscopic radical resection. Our secondary purpose is to explore the effects of perioperative circulating tumor cells on tumor recurrence and metastasis.
Detailed description
Mid-low rectal cancer is one of the common malignant tumors and the incidence has increased significantly in recent years. At present, surgery is still the most important and effective method for the treatment of mid-low rectal cancer. Traditional laparoscopic surgery and emerging transanal total mesorectal excision (TaTME) are the main methods. More than one-third of rectal cancer patients will eventually occur local recurrence and distant metastasis, which are the most important factors affecting prognosis. Circulating tumor cells may lead to distant metastasis, so the detection of CTCs in blood has important clinical significance in predicting the recurrence and metastasis of rectal cancer and monitoring treatment response. Due to the different degrees of contact between distinct surgical methods, this may lead to an increase in the quantity of CTCs in the blood, which may affect the prognosis of patients. Therefore, the investigators conducted a randomized controlled study to compare the changes in the quantity of CTCs in the central vein before, during and after operation in rectal cancer patients undergoing transanal endoscopic or laparoscopic radical resection. To explore the effect of two surgical methods on the risk of micrometastasis, and to provide evidence for the selection and improvement of rectal cancer treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic surgery | – | Procedure: Surgical approachLaparoscopic total mesorectal excision was performed on the enrolled patients. |
| Transanal endoscopic surgery | – | Procedure: Surgical approachTransanal total mesorectal excision was performed on the enrolled patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 rectal cancer patients will be enrolled. Patients must be older than 18 years.
Key inclusion criteria (4 listed)
- Mid-low rectal cancer.
- Single lesion.
- No metastasis.
- Clinical Stage T2-3, N0-1.
Key exclusion criteria (9 listed)
- History of malignant tumors.
- Acute bowel obstruction, bleeding or perforation.
- Received neoadjuvant treatment.
- Tumor over 6cm in diameter or in severe adhesion with surrounded tissues.
- Severe other contradictions of surgery.
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 |
|---|---|---|
| Surgical approachDifferent surgical methods for rectal cancer resection | Procedure or surgery | Transanal endoscopic surgery, laparoscopic surgery |
Primary outcome
Change of circulating tumor cells during laparoscopic or transanal endoscopic surgery
Time frame: 1 years
To determine the changes of circulating tumor cells in rectal cancer patients undergoing laparoscopic or transanal endoscopic radical resection before operation and 5 days after operation.
1 secondary outcome
Disease free survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- 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.
Liang Huang principal investigator
Sun Yat-sen University Sixth Affiliated Hospital
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 Rectal Neoplasms and Neoplastic Cells, Circulating, run by Sun Yat-sen University 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 4 inclusion and 9 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 13 Apr 2023. 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?
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?
Change of circulating tumor cells during laparoscopic or transanal endoscopic surgery (time frame: 1 years). 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 13 Apr 2023.