Rectal CancerNCT05316103
Targeted Optical Biopsy for Local Rectal Scars in Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy
A study testing Probe-based confocal laser endomicroscopy targeted optical biopsy in people with Rectal Cancer, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Currently, low concordance (36%) is found between clinical complete response and pathologic complete response in patients with rectal cancer after neoadjuvant chemoradiotherapy. Probe-based confocal laser endoscopy (pCLE) provides a promising targeted optical biopsy to evaluate the response to neoadjuvant… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Probe-based confocal laser endomicroscopy targeted optical biopsy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2021to 1 Nov 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from over 18 to under 80 years
- American Society of Anesthesiology(ASA) score class I,II,or III
- Locally advanced rectal cancer
- Patient has completed standard neoadjuvant therapy
- Expected surgical resection
- Written informed consent
Who cannot join
- Pregnant or lactating women
- Acute renal insufficiency or stage II to IV chronic renal insufficiency
- 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 Targeted Optical Biopsy for Local Rectal Scars in Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy
Currently, low concordance (36%) is found between clinical complete response and pathologic complete response in patients with rectal cancer after neoadjuvant chemoradiotherapy. Probe-based confocal laser endoscopy (pCLE) provides a promising targeted optical biopsy to evaluate the response to neoadjuvant chemoradiotherapy. The aim of this study is to investigate whether pCLE-targeted optical biopsy can improve the accuracy of preoperative endoscopic biopsy for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy.
Read the detailed description
Patients with locally advanced rectal cancer can benefit from neoadjuvant chemoradiotherapy, and 20%-30% of patients receiving such therapy can attain a pathologic complete response, defined as the eradication of cancer cells. For those who reach pathologic complete response, a watch-and-wait strategy is supposed to be the best choice. However, low concordance (36%) was found between clinical complete response and pathologic complete response in patients with rectal cancer after neoadjuvant chemoradiotherapy. There is a compelling need to improve the consistency.
Probed-based confocal laser endoscopy (pCLE) is a novel endoscopic adjunct that allows 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. It provides a promising targeted optical biopsy for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy.
The investigators perform this study to investigate whether pCLE-targeted optical biopsy could improve the accuracy of preoperative endoscopic biopsy for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy. In this study, rectal cancer patients after neoadjuvant chemoradiotherapy will be successively arranged to accept traditional endoscopic biopsy and pCLE-based targeted optical biopsy. The consistency rate will be calculated according to the postoperative pathological results.
- Conditions
- Rectal Cancer
- Being tested
- Probe-based confocal laser endomicroscopy targeted optical biopsy
- Keywords
- rectal cancer, confocal laser endomicroscopy, optical biopsy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probe-based confocal laser endomicroscopy targeted optical biopsyDevice
After intravenous injection of fluorescein sodium, pCLE-based targeted optical biopsy will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic biopsy and probe-based confocal laser endomicroscopy biopsy | Experimental | In this study , endoscopic biopsy and pCLE-targeted optical biopsy will be successively performed for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy. Receives: Device: Probe-based confocal laser endomicroscopy targeted optical biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of pCLE-targeted optical biopsy
The investigators will use pCLE-targeted optical biopsy for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy and compare the pathological diagnosis between optical biopsy and surgically resected specimens.
Measured: 7 days
Secondary outcomes (2)
Sensitivity,specificity,positive predictive value and negative predictive value of pCLE targeted optical biopsy
The investigators will use pCLE-targeted optical biopsy for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy and compare the pathological diagnosis between optical biopsy and surgically resected specimens.
Measured: 7 days
Complications of biopsy
Complications of biopsy, such as bleeding and drug allergies.
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 posted7 Apr 2022
- Study start4 Nov 2021
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rectal 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
- 68 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
- NCT05316103
- Sponsor's protocol ID
- NFEC-2022-063
- Status last verified
- May 2023
- First submitted
- 30 Mar 2022
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gash KJ, Baser O, Kiran RP. Factors associated with degree of tumour response to neo-adjuvant radiotherapy in rectal cancer and subsequent corresponding outcomes. Eur J Surg Oncol. 2017 Nov;43(11):2052-2059. doi: 10.1016/j.ejso.2017.07.024. Epub 2017 Aug 10.
PubMed 28943178van der Sande ME, Maas M, Melenhorst J, Breukink SO, van Leerdam ME, Beets GL. Predictive Value of Endoscopic Features for a Complete Response After Chemoradiotherapy for Rectal Cancer. Ann Surg. 2021 Dec 1;274(6):e541-e547. doi: 10.1097/SLA.0000000000003718.
PubMed 31851000Ryan JE, Warrier SK, Lynch AC, Heriot AG. Assessing pathological complete response to neoadjuvant chemoradiotherapy in locally advanced rectal cancer: a systematic review. Colorectal Dis. 2015 Oct;17(10):849-61. doi: 10.1111/codi.13081.
PubMed 26260213Glynne-Jones R, Wallace M, Livingstone JI, Meyrick-Thomas J. Complete clinical response after preoperative chemoradiation in rectal cancer: is a "wait and see" policy justified? Dis Colon Rectum. 2008 Jan;51(1):10-9; discussion 19-20. doi: 10.1007/s10350-007-9080-8. Epub 2007 Nov 28.
PubMed 18043968Al-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 32405892Safatle-Ribeiro AV, Marques CFS, Pires C, Arraes L, Baba ER, Meirelles L, Kawaguti FS, da Costa Martins B, Lenz LT, de Lima MS, Gusmon-Oliveira CC, Ribeiro U Jr, Maluf-Filho F, Nahas SC. Diagnosis of Clinical Complete Response by Probe-Based Confocal Laser Endomicroscopy (pCLE) After Chemoradiation for Advanced Rectal Cancer. J Gastrointest Surg. 2021 Feb;25(2):357-368. doi: 10.1007/s11605-020-04878-y. Epub 2021 Jan 14.
PubMed 33443686
Study at a glance
From the registry record, last updated by the sponsor on 12 May 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 Targeted Optical Biopsy for Local Rectal Scars in Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT05316103
- Acronym / sponsor ID
- NFEC-2022-063
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, confocal laser endomicroscopy, optical biopsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 7 Apr 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.
Currently, low concordance (36%) is found between clinical complete response and pathologic complete response in patients with rectal cancer after neoadjuvant chemoradiotherapy. Probe-based confocal laser endoscopy (pCLE) provides a promising targeted optical biopsy to evaluate the response to neoadjuvant chemoradiotherapy. The aim of this study is to investigate whether pCLE-targeted optical biopsy can improve the accuracy of preoperative endoscopic biopsy for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy.
Detailed description
Patients with locally advanced rectal cancer can benefit from neoadjuvant chemoradiotherapy, and 20%-30% of patients receiving such therapy can attain a pathologic complete response, defined as the eradication of cancer cells. For those who reach pathologic complete response, a watch-and-wait strategy is supposed to be the best choice. However, low concordance (36%) was found between clinical complete response and pathologic complete response in patients with rectal cancer after neoadjuvant chemoradiotherapy. There is a compelling need to improve the consistency.
Probed-based confocal laser endoscopy (pCLE) is a novel endoscopic adjunct that allows 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. It provides a promising targeted optical biopsy for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy.
The investigators perform this study to investigate whether pCLE-targeted optical biopsy could improve the accuracy of preoperative endoscopic biopsy for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy. In this study, rectal cancer patients after neoadjuvant chemoradiotherapy will be successively arranged to accept traditional endoscopic biopsy and pCLE-based targeted optical biopsy. The consistency rate will be calculated according to the postoperative pathological results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic biopsy and probe-based confocal laser endomicroscopy biopsy | Experimental | Device: Probe-based confocal laser endomicroscopy targeted optical biopsyIn this study , endoscopic biopsy and pCLE-targeted optical biopsy will be successively performed for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age from over 18 to under 80 years
- American Society of Anesthesiology(ASA) score class I,II,or III
- Locally advanced rectal cancer
- Patient has completed standard neoadjuvant therapy
- Expected surgical resection
Key exclusion criteria (3 listed)
- Pregnant or lactating women
- Acute renal insufficiency or stage II to IV chronic renal insufficiency
- 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 |
|---|---|---|
| Probe-based confocal laser endomicroscopy targeted optical biopsyAfter intravenous injection of fluorescein sodium, pCLE-based targeted optical biopsy will be performed. | Device | Endoscopic biopsy and probe-based confocal laser endomicroscopy biopsy |
Primary outcome
Accuracy of pCLE-targeted optical biopsy
Time frame: 7 days
The investigators will use pCLE-targeted optical biopsy for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy and compare the pathological diagnosis between optical biopsy and surgically resected specimens.
2 secondary outcomes
Sensitivity,specificity,positive predictive value and negative predictive value of pCLE targeted optical biopsy
Time frame: 7 days
Complications of 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 12 May 2023.
- Background: PubMed 28943178Gash KJ, Baser O, Kiran RP. Factors associated with degree of tumour response to neo-adjuvant radiotherapy in rectal cancer and subsequent corresponding outcomes. Eur J Surg Oncol. 2017 Nov;43(11):2052-2059. doi: 10.1016/j.ejso.2017.07.024. Epub 2017 Aug 10.
- Background: PubMed 31851000van der Sande ME, Maas M, Melenhorst J, Breukink SO, van Leerdam ME, Beets GL. Predictive Value of Endoscopic Features for a Complete Response After Chemoradiotherapy for Rectal Cancer. Ann Surg. 2021 Dec 1;274(6):e541-e547. doi: 10.1097/SLA.0000000000003718.
- Background: PubMed 26260213Ryan JE, Warrier SK, Lynch AC, Heriot AG. Assessing pathological complete response to neoadjuvant chemoradiotherapy in locally advanced rectal cancer: a systematic review. Colorectal Dis. 2015 Oct;17(10):849-61. doi: 10.1111/codi.13081.
- Background: PubMed 18043968Glynne-Jones R, Wallace M, Livingstone JI, Meyrick-Thomas J. Complete clinical response after preoperative chemoradiation in rectal cancer: is a "wait and see" policy justified? Dis Colon Rectum. 2008 Jan;51(1):10-9; discussion 19-20. doi: 10.1007/s10350-007-9080-8. Epub 2007 Nov 28.
- 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 33443686Safatle-Ribeiro AV, Marques CFS, Pires C, Arraes L, Baba ER, Meirelles L, Kawaguti FS, da Costa Martins B, Lenz LT, de Lima MS, Gusmon-Oliveira CC, Ribeiro U Jr, Maluf-Filho F, Nahas SC. Diagnosis of Clinical Complete Response by Probe-Based Confocal Laser Endomicroscopy (pCLE) After Chemoradiation for Advanced Rectal Cancer. J Gastrointest Surg. 2021 Feb;25(2):357-368. doi: 10.1007/s11605-020-04878-y. Epub 2021 Jan 14.
- 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 Probe-based confocal laser endomicroscopy targeted optical biopsy in people with Rectal 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 6 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: looking for participants now, as of the sponsor's last update on 12 May 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-targeted 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 NCT05316103, which also lists 6 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 12 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.