Targeted Optical Biopsy for Local Rectal Scars in Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy
Use of Probe-based Confocal Laser Endomicroscopy to Perform Targeted Optical Biopsy for Local Rectal Scars in Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy
1 other identifier
interventional
68
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 4, 2021
CompletedFirst Submitted
Initial submission to the registry
March 30, 2022
CompletedFirst Posted
Study publicly available on registry
April 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
May 12, 2023
May 1, 2023
5 years
March 30, 2022
May 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
7 days
Secondary Outcomes (2)
Sensitivity,specificity,positive predictive value and negative predictive value of pCLE targeted optical biopsy
7 days
Complications of biopsy
7 days
Study Arms (1)
Endoscopic biopsy and probe-based confocal laser endomicroscopy biopsy
EXPERIMENTALIn this study , endoscopic biopsy and pCLE-targeted optical biopsy will be successively performed for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy.
Interventions
After intravenous injection of fluorescein sodium, pCLE-based targeted optical biopsy will be performed.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant or lactating women
- Acute renal insufficiency or stage II to IV chronic renal insufficiency
- Patients with allergic constitution
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510000, China
Related Publications (6)
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.
PMID: 28943178BACKGROUNDvan 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.
PMID: 31851000BACKGROUNDRyan 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.
PMID: 26260213BACKGROUNDGlynne-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.
PMID: 18043968BACKGROUNDAl-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.
PMID: 32405892BACKGROUNDSafatle-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.
PMID: 33443686BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jun Yan, M.D., Ph.D.
Nanfang Hospital, Southern Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2022
First Posted
April 7, 2022
Study Start
November 4, 2021
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
May 12, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share