Rectal CancerNCT05374044
Establishment of MRI Model for pTRG in Rectal Cancer With Establishment of
An observational study of Rectal Cancer, run by Peking University Cancer Hospital & Institute at 3 sites in China.
Trial summary
This study proposeto integrate a variety of imaging quantitative indicators to establish a new MRI-based tumor response regression(mrTRG) classification method. The accuracy of the established mrTRG classification method according pathology TRG(pTRG) will be tested. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- pelvic MRI for establishing new mrTRG method
- How many people
- 385 participants
- Where
- 3 sitesChina
- Study dates
- 18 May 2020to 31 Dec 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: biopsy-proved primary locally advanced rectal adenocarcinoma(cT3 and/or cN+)
Who may be able to join
- biopsy-proved primary rectal cancer
- baseline MRI confirmed LARC (cT3 and/or cN+)
- scheduled to take neoadjuvant therapy
- receive baseline and preoperative pelvic MRI
- receive TME surgery after NAT
- have routine follow-up after the operation
Who cannot join
- history of malignancy or multiple primary cancers
- receive surgery directly without NAT
- don't receive TME surgery
- don't complete NAT
- simultaneous distant metastasis at the baseline diagnosis
- lack of baseline or preoperative pelvic MRI
- incomplete or unavailable pathological information
- lost to follow-up within three months after surgery (lost since the first follow-up visit)
Trial locations and contacts
3 sites in 1 country.
China3 sites
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100039
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100142
About this study
Official title: Establishment of a Quantified Imaging Method for Evaluating Tumor Response Grade in Rectal Cancer Patient With Neoadjuvant Therapy: a Multi-center Study
This study proposeto integrate a variety of imaging quantitative indicators to establish a new MRI-based tumor response regression(mrTRG) classification method. The accuracy of the established mrTRG classification method according pathology TRG(pTRG) will be tested. The ability of the established mrTRG classification method to predict prognosis will also be tested.
Read the detailed description
The study included two part: one is a retrospective single-center cohort for analyzing quantitative MRI factors associated with pTRG, from which a new MRI-based tumor response regression(mrTRG) classification method will be established. The other is a prospective multi-center cohort for testing the accuracy of the established mrTRG classification according to pTRG; and also for validating the established mrTRG classification associated with survival.
- Conditions
- Rectal Cancer
- Being tested
- pelvic MRI for establishing new mrTRG method
- Keywords
- rectal cancer, neoadjuvant therapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic MRI for establishing new mrTRG methodDiagnostic test
they will received two pelvic MR examinations before and after neoadjvant therapy. The MRI before neoadjvant therapy is considered as baseline MRI, which is usually taken within 3 weeks before NAT. The MRI after neoadjvant therapy is considered as preoperative MRI, which is usually taken within 3-8 weeks before NAT.
| Study group | Role | What they receive |
|---|---|---|
| rectal cancer with NAT | The patients are planned to receive neoadjvant therapy, and then receive radical surgery. Receives: Diagnostic Test: pelvic MRI for establishing new mrTRG method |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological tumor regression grade(pTRG)
pTRG is evaluated according to the AJCC system. pTRG0-1 is defined as good response, pTRG2 as moderate response, and pTRG3 as poor response. The pTRG is judged by two experienced pathologists working together. If there are any discrepancies, then a third senior pathologist is consulted for arbitration. there were any discrepancies, then a third senior pathologist was consulted. there were any discrepancies, then a third senior pathologist was consulted.
Measured: within 2 weeks after surgery
Secondary outcomes (3)
distant metastasis
Distant metastastic lesion detected by follow-up CT which will be performed every 3 month for the first two year and every 6 month since the third year
Measured: 3 years from the data of surgery
Death
all cause death
Measured: 3 years from the data of surgery
local recurrence
Measured: 3 years from the data of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start18 May 2020
- Primary completion30 Apr 2023
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Capital's Funds for Health Improvement and Research (2020-1- 2151).
- Responsible party
- Principal investigator, Sun Ying-Shi, Peking University Cancer Hospital & Institute
- Investigators
- Ying-Shi Sun, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374044
- Sponsor's protocol ID
- SF2020-1-2151
- Status last verified
- Jun 2023
- First submitted
- 14 Dec 2021
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- 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 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Quantified Imaging Method for Evaluating Tumor Response Grade in Rectal Cancer Patient With Neoadjuvant Therapy: a Multi-center Study
- ClinicalTrials.gov ID
- NCT05374044
- Acronym / sponsor ID
- SF2020-1-2151
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, neoadjuvant therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Capital's Funds for Health Improvement and Research (2020-1- 2151).
- Study start
- 18 May 2020 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 May 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.
This study proposeto integrate a variety of imaging quantitative indicators to establish a new MRI-based tumor response regression(mrTRG) classification method. The accuracy of the established mrTRG classification method according pathology TRG(pTRG) will be tested. The ability of the established mrTRG classification method to predict prognosis will also be tested.
Detailed description
The study included two part: one is a retrospective single-center cohort for analyzing quantitative MRI factors associated with pTRG, from which a new MRI-based tumor response regression(mrTRG) classification method will be established. The other is a prospective multi-center cohort for testing the accuracy of the established mrTRG classification according to pTRG; and also for validating the established mrTRG classification associated with survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rectal cancer with NAT | – | Diagnostic Test: pelvic MRI for establishing new mrTRG methodThe patients are planned to receive neoadjvant therapy, and then receive radical surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- biopsy-proved primary locally advanced rectal adenocarcinoma(cT3 and/or cN+)
Key inclusion criteria (6 listed)
- biopsy-proved primary rectal cancer
- baseline MRI confirmed LARC (cT3 and/or cN+)
- scheduled to take neoadjuvant therapy
- receive baseline and preoperative pelvic MRI
- receive TME surgery after NAT
Key exclusion criteria (8 listed)
- history of malignancy or multiple primary cancers
- receive surgery directly without NAT
- don't receive TME surgery
- don't complete NAT
- simultaneous distant metastasis at the baseline diagnosis
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 |
|---|---|---|
| pelvic MRI for establishing new mrTRG methodthey will received two pelvic MR examinations before and after neoadjvant therapy. The MRI before neoadjvant therapy is considered as baseline MRI, which is usually taken within 3 weeks before NAT. The MRI after neoadjvant therapy is considered as preoperative MRI, which is usually taken within 3-8 weeks before NAT. | Diagnostic test | rectal cancer with NAT |
Primary outcome
pathological tumor regression grade(pTRG)
Time frame: within 2 weeks after surgery
pTRG is evaluated according to the AJCC system. pTRG0-1 is defined as good response, pTRG2 as moderate response, and pTRG3 as poor response. The pTRG is judged by two experienced pathologists working together. If there are any discrepancies, then a third senior pathologist is consulted for arbitration. there were any discrepancies, then a third senior pathologist was consulted. there were any discrepancies, then a third senior pathologist was consulted.
3 secondary outcomes
distant metastasis
Time frame: 3 years from the data of surgery
Death
Time frame: 3 years from the data of surgery
local recurrence
Time frame: 3 years from the data of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 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.
Ying-Shi Sun, MD principal investigator
Peking University Cancer Hospital & Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Peking University Cancer Hospital & Institute at 3 sites 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 8 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
pathological tumor regression grade(pTRG) (time frame: within 2 weeks after surgery). 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 22 Jun 2023.