Rectal CancerNCT04527939
Analysis of Extraperitoneal Rectal Neoplasms Between 3D Endorectal Ultrasonography and Magnification Chromoendoscopy
A study testing three-dimensional endorectal ultrasonography in people with Rectal Cancer and Rectal Cancer Stage I, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
ERUS-3D and CMI demonstrated good diagnostic accuracy in parietal staging of rectal extraperitoneal neoplasms, however with greater efficiency of the endoscopic method. The association of studies can improve diagnostic efficacy and influence the most appropriate approach. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer, Rectal Cancer Stage I
- What is being tested?
- three-dimensional endorectal ultrasonography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Aug 2020to 7 Aug 2023
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: patients with diagnosis of mid or distal rectum neoplasms stage 1 -
Exclusion Criteria: advanced rectal cancer (stage II, III or IV)
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Results of the Comparative Analysis of Invasion Depth of Extraperitoneal Rectal Neoplasms Between Three-dimensional Endorectal Ultrasonography and Magnification Chromoendoscopy
ERUS-3D and CMI demonstrated good diagnostic accuracy in parietal staging of rectal extraperitoneal neoplasms, however with greater efficiency of the endoscopic method. The association of studies can improve diagnostic efficacy and influence the most appropriate approach.
Read the detailed description
Larger lesions present less chance of deep parietal invasion. The methods show moderate agreement with each other for lesion size and distance from the anal verge and good agreement for the rectal wall percentage of involvement. Circumferential or almost circumferential lesions have a greater chance of postoperative stenosis. Patients with more advanced lesions on AP who underwent radical resections had lower overall survival.
- Conditions
- Rectal Cancer, Rectal Cancer Stage I
- Being tested
- three-dimensional endorectal ultrasonography
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
three-dimensional endorectal ultrasonographyProcedure or surgery
three-dimensional endorectal ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| three-dimensional endorectal ultrasonography | Active comparator | three-dimensional endorectal ultrasonography Receives: Procedure: three-dimensional endorectal ultrasonography |
| magnification chromoendoscopy. | Sham comparator | magnification chromoendoscopy. Receives: Procedure: three-dimensional endorectal ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of parietal invasion (T),
Patients with Stage T after procedure
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start7 Aug 2020
- Primary completion10 Aug 2020
- Study completion7 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 University of Sao PauloThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Extraperitoneal rectal cancer stage 1
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo Alfonso Bustamante, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527939
- Sponsor's protocol ID
- 9076079
- Status last verified
- Aug 2020
- First submitted
- 19 Aug 2020
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: comparative analysis of invasion depth of extraperitoneal rectal neoplasms between three-dimensional endorectal ultrasonography and magnification chromoendoscopy.
Publications
Nahas SC, Nahas CSR, Bustamante-Lopez LA, Pinto RA, Marques CFS, Cecconello I. Outcomes of surgical treatment for patients with distal rectal cancer: A retrospective review from a single university hospital. Rev Gastroenterol Mex (Engl Ed). 2020 Apr-Jun;85(2):180-189. doi: 10.1016/j.rgmx.2019.05.009. Epub 2020 Feb 11. English, Spanish.
PubMed 32057523Kawaguti FS, Franco MC, Martins BC, Segateli V, Marques CFS, Nahas CSR, Pinto RA, Safatle-Ribeiro AV, Ribeiro-Junior U, Nahas SC, Maluf-Filho F. Role of Magnification Chromoendoscopy in the Management of Colorectal Neoplastic Lesions Suspicious for Submucosal Invasion. Dis Colon Rectum. 2019 Apr;62(4):422-428. doi: 10.1097/DCR.0000000000001343.
PubMed 30730457Pinto RA, Correa Neto IJ, Nahas SC, Rizkalah Nahas CS, Sparapan Marques CF, Ribeiro Junior U, Kawaguti FS, Cecconello I. Efficacy of 3-Dimensional Endorectal Ultrasound for Staging Early Extraperitoneal Rectal Neoplasms. Dis Colon Rectum. 2017 May;60(5):488-496. doi: 10.1097/DCR.0000000000000781.
PubMed 28383448
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of the Comparative Analysis of Invasion Depth of Extraperitoneal Rectal Neoplasms Between Three-dimensional Endorectal Ultrasonography and Magnification Chromoendoscopy
- ClinicalTrials.gov ID
- NCT04527939
- Acronym / sponsor ID
- 9076079
- Conditions
- Rectal Cancer, Rectal Cancer Stage I
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- 10 Aug 2020 (actual)
- Study completion
- 7 Aug 2023 (estimated)
- First posted
- 27 Aug 2020 (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.
ERUS-3D and CMI demonstrated good diagnostic accuracy in parietal staging of rectal extraperitoneal neoplasms, however with greater efficiency of the endoscopic method. The association of studies can improve diagnostic efficacy and influence the most appropriate approach.
Detailed description
Larger lesions present less chance of deep parietal invasion. The methods show moderate agreement with each other for lesion size and distance from the anal verge and good agreement for the rectal wall percentage of involvement. Circumferential or almost circumferential lesions have a greater chance of postoperative stenosis. Patients with more advanced lesions on AP who underwent radical resections had lower overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Extraperitoneal rectal cancer stage 1
| Arm | Type | Receives |
|---|---|---|
| three-dimensional endorectal ultrasonography | Active comparator | Procedure: three-dimensional endorectal ultrasonographythree-dimensional endorectal ultrasonography |
| magnification chromoendoscopy. | Sham comparator | Procedure: three-dimensional endorectal ultrasonographymagnification chromoendoscopy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| three-dimensional endorectal ultrasonographythree-dimensional endorectal ultrasonography | Procedure or surgery | magnification chromoendoscopy., three-dimensional endorectal ultrasonography |
Primary outcome
Degree of parietal invasion (T),
Time frame: immediately after the procedure
Patients with Stage T after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
- Results publication: PubMed 32057523Nahas SC, Nahas CSR, Bustamante-Lopez LA, Pinto RA, Marques CFS, Cecconello I. Outcomes of surgical treatment for patients with distal rectal cancer: A retrospective review from a single university hospital. Rev Gastroenterol Mex (Engl Ed). 2020 Apr-Jun;85(2):180-189. doi: 10.1016/j.rgmx.2019.05.009. Epub 2020 Feb 11. English, Spanish.
- Results publication: PubMed 30730457Kawaguti FS, Franco MC, Martins BC, Segateli V, Marques CFS, Nahas CSR, Pinto RA, Safatle-Ribeiro AV, Ribeiro-Junior U, Nahas SC, Maluf-Filho F. Role of Magnification Chromoendoscopy in the Management of Colorectal Neoplastic Lesions Suspicious for Submucosal Invasion. Dis Colon Rectum. 2019 Apr;62(4):422-428. doi: 10.1097/DCR.0000000000001343.
- Results publication: PubMed 28383448Pinto RA, Correa Neto IJ, Nahas SC, Rizkalah Nahas CS, Sparapan Marques CF, Ribeiro Junior U, Kawaguti FS, Cecconello I. Efficacy of 3-Dimensional Endorectal Ultrasound for Staging Early Extraperitoneal Rectal Neoplasms. Dis Colon Rectum. 2017 May;60(5):488-496. doi: 10.1097/DCR.0000000000000781.
- Individual participant dataSharing planned: No. comparative analysis of invasion depth of extraperitoneal rectal neoplasms between three-dimensional endorectal ultrasonography and magnification chromoendoscopy.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing three-dimensional endorectal ultrasonography in people with Rectal Cancer and Rectal Cancer Stage I, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 27 Aug 2020. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Degree of parietal invasion (T), (time frame: immediately after the procedure). 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 NCT04527939, which also lists 3 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 27 Aug 2020.