Colorectal CancerNCT05879783
Optical Biopsy for Peritoneal Nodules in Colorectal Patients
A study testing Confocal laser endomicroscopy in people with Colorectal Cancer, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
During surgery, peritoneal metastasis is typically confirmed pathologically through resection sample. However, this process can be time-consuming when utilizing intro-operative frozen section pathology. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Confocal laser endomicroscopy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2022to 15 Dec 2027
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from over 18 to under 85 years
- American Society of Anesthesiology (ASA) score class I,II,or III
- Colorectal cancer
- Patients who be about to undergo surgical treatment
- Written informed consent
Who cannot join
- Pregnant or lactating women
- Acute renal insufficiency or stage II to IV chronic renal insufficiency
- Patients with severe liver damage
- Asthma patients or patients with allergic constitution
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510000
Jun Yan, M.D.,Ph.D, 086-13825066546, yanjunfudan@163.com
About this study
Official title: Use of Probe-based Confocal Laser Endomicroscopy to Perform Optical Biopsy for Peritoneal Nodules in Colorectal Cancer Patients During Surgery
During surgery, peritoneal metastasis is typically confirmed pathologically through resection sample. However, this process can be time-consuming when utilizing intro-operative frozen section pathology. To address this issue, we propose utilizing confocal laser endomicroscopy to provide in situ, real-time, and in-vivo diagnosis of suspected peritoneal nodules as cancer metastasis during surgery.
Read the detailed description
Peritoneal metastasis is a common metastatic site in colorectal cancer patients, and those with peritoneal metastasis often have a poor prognosis. During surgery, peritoneal metastasis is confirmed pathologically through resection sample, but frozen section pathology can take up to 30 minutes, which is a significant amount of time.
To address this issue, we suggest utilizing probed-based confocal laser endoscopy (pCLE), a novel endoscopic adjunct that enables real-time in vivo histological examination of mucosal surfaces. By using intravenous fluorescent agents, pCLE highlights certain mucosal elements that facilitate an optical biopsy in real time.
By providing a promising optical biopsy, CLE has the potential to enable in situ, real-time, and in vivo diagnosis of colorectal cancer patients with peritoneal nodules during surgery.
- Conditions
- Colorectal Cancer
- Being tested
- Confocal laser endomicroscopy
- Keywords
- Colorectal cancer, Confocal laser endomicroscopy, Optical biopsy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confocal laser endomicroscopyDiagnostic test
After intravenous injection of fluorescein sodium, pCLE-based optical biopsy will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Probe-based confocal laser endomicroscopy biopsy | Experimental | In this study , pCLE-based optical biopsy will be successively performed for peritoneal nodules in colorectal cancer patients during surgical operation. Receives: Diagnostic Test: Confocal laser endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of pCLE optical biopsy
The investigators will use pCLE optical biopsy for peritoneal nodules in colorectal cancer patients and compare the pathological diagnosis between optical biopsy and surgically resected specimens.
Measured: 7 days
Secondary outcomes (2)
Sensitivity, specificity of pCLE optical biopsy
The investigators will use pCLE optical biopsy for peritoneal nodules in colorectal cancer patients and compare the pathological diagnosis between optical biopsy and surgically resected specimens.
Measured: 7 days
The positive predictive value and negative predictive value of pCLE optical biopsy
The investigators will use pCLE optical biopsy for peritoneal nodules in colorectal cancer patients and compare the pathological diagnosis between optical biopsy and surgically resected specimens.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start15 Sep 2022
- Primary completion15 Sep 2023 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Yan, M.D., Ph.D., Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879783
- Sponsor's protocol ID
- NFEC-2023-088
- Status last verified
- Aug 2023
- First submitted
- 19 May 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Mansour MR, Caycedo-Marulanda A, Davis BR, Alawashez A, Docimo S, Qureshi A, Tsuda S. SAGES TAVAC safety and efficacy analysis confocal laser endomicroscopy. Surg Endosc. 2021 May;35(5):2091-2103. doi: 10.1007/s00464-020-07607-3. Epub 2020 May 13.
PubMed 32405892Baratti D, Kusamura S, Pietrantonio F, Guaglio M, Niger M, Deraco M. Progress in treatments for colorectal cancer peritoneal metastases during the years 2010-2015. A systematic review. Crit Rev Oncol Hematol. 2016 Apr;100:209-22. doi: 10.1016/j.critrevonc.2016.01.017. Epub 2016 Jan 22.
PubMed 26867984
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Probe-based Confocal Laser Endomicroscopy to Perform Optical Biopsy for Peritoneal Nodules in Colorectal Cancer Patients During Surgery
- ClinicalTrials.gov ID
- NCT05879783
- Acronym / sponsor ID
- NFEC-2023-088
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Confocal laser endomicroscopy, Optical biopsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 15 Sep 2023 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 30 May 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.
During surgery, peritoneal metastasis is typically confirmed pathologically through resection sample. However, this process can be time-consuming when utilizing intro-operative frozen section pathology. To address this issue, we propose utilizing confocal laser endomicroscopy to provide in situ, real-time, and in-vivo diagnosis of suspected peritoneal nodules as cancer metastasis during surgery.
Detailed description
Peritoneal metastasis is a common metastatic site in colorectal cancer patients, and those with peritoneal metastasis often have a poor prognosis. During surgery, peritoneal metastasis is confirmed pathologically through resection sample, but frozen section pathology can take up to 30 minutes, which is a significant amount of time.
To address this issue, we suggest utilizing probed-based confocal laser endoscopy (pCLE), a novel endoscopic adjunct that enables real-time in vivo histological examination of mucosal surfaces. By using intravenous fluorescent agents, pCLE highlights certain mucosal elements that facilitate an optical biopsy in real time.
By providing a promising optical biopsy, CLE has the potential to enable in situ, real-time, and in vivo diagnosis of colorectal cancer patients with peritoneal nodules during surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probe-based confocal laser endomicroscopy biopsy | Experimental | Diagnostic Test: Confocal laser endomicroscopyIn this study , pCLE-based optical biopsy will be successively performed for peritoneal nodules in colorectal cancer patients during surgical operation. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age from over 18 to under 85 years
- American Society of Anesthesiology (ASA) score class I,II,or III
- Colorectal cancer
- Patients who be about to undergo surgical treatment
- Written informed consent
Key exclusion criteria (4 listed)
- Pregnant or lactating women
- Acute renal insufficiency or stage II to IV chronic renal insufficiency
- Patients with severe liver damage
- Asthma patients or patients with allergic constitution
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 |
|---|---|---|
| Confocal laser endomicroscopyAfter intravenous injection of fluorescein sodium, pCLE-based optical biopsy will be performed. | Diagnostic test | Probe-based confocal laser endomicroscopy biopsy |
Primary outcome
Accuracy of pCLE optical biopsy
Time frame: 7 days
The investigators will use pCLE optical biopsy for peritoneal nodules in colorectal cancer patients and compare the pathological diagnosis between optical biopsy and surgically resected specimens.
2 secondary outcomes
Sensitivity, specificity of pCLE optical biopsy
Time frame: 7 days
The positive predictive value and negative predictive value of pCLE optical biopsy
Time frame: 7 days
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 23 Aug 2023.
- Background: PubMed 32405892Al-Mansour MR, Caycedo-Marulanda A, Davis BR, Alawashez A, Docimo S, Qureshi A, Tsuda S. SAGES TAVAC safety and efficacy analysis confocal laser endomicroscopy. Surg Endosc. 2021 May;35(5):2091-2103. doi: 10.1007/s00464-020-07607-3. Epub 2020 May 13.
- Background: PubMed 26867984Baratti D, Kusamura S, Pietrantonio F, Guaglio M, Niger M, Deraco M. Progress in treatments for colorectal cancer peritoneal metastases during the years 2010-2015. A systematic review. Crit Rev Oncol Hematol. 2016 Apr;100:209-22. doi: 10.1016/j.critrevonc.2016.01.017. Epub 2016 Jan 22.
- 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.
Jun Yan, M.D., Ph.D. principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Confocal laser endomicroscopy in people with Colorectal Cancer, run by Nanfang Hospital, Southern Medical 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 5 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 23 Aug 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?
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 Jun Yan, M.D., Ph.D. (086-13825066546, yanjunfudan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of pCLE optical biopsy (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05879783, which also lists 2 linked publications.
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 23 Aug 2023.