Rectal CancerNCT04392609
Predicting Locally Advanced Rectal Cancer Response to NCT and NCRT With MRI
An observational study of Rectal Cancer and MRI, run by Ziqiang Wang,MD at 1 site in China.
Trial summary
This trial was designed to to study whether there is a difference in MRI image evaluation between NCRT and NCT, and try to build a model to predict the efficacy of neoadjuvant therapy by combining multiple imaging indexes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Cancer, MRI
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2020to 15 Jul 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with locally advanced rectal cancer who started neoadjuvant chemoradiotherapy and underwent radical surgery in West of China Hospital and completed the required MR examination before and after neoadjuvant treatment were included from March 2016 to December 2019.
Who may be able to join
- pathological diagnosis of rectal cancer;
- received neoadjuvant chemoradiotherapy before surgery;
- before neoadjuvant therapy and before surgery, the patients received thin and high resolution MRI examination of the rectum.
- before neoadjuvant therapy, colonoscopy, rectal contrast-enhanced ultrasound or MRI showed that the lower margin of the tumor was within 12cm from the anal margin;
- pre-neoadjuvant clinical stage II/III (AJCC 7th edition);
Who cannot join
- simultaneous distant metastatic tumor should be considered at the first diagnosis;
- patients with distant metastasis were not considered at the initial diagnosis;
- with other malignant tumors;
- before neoadjuvant therapy, patients had received other relevant treatments;
- to undergo palliative surgery or emergency surgery in the course of neoadjuvant therapy;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guoxue Road 37#,West China Hospital
Chengdu, Sichuan, 610041
Ziqiang Wang, MD, 18980602028, wangtrial@163.com
About this study
Official title: Predicting Locally Advanced Rectal Cancer Response to NCT and NCRT With MRI, and Comparison of MR Imaging Evaluation Between NCT and NCRT
This trial was designed to to study whether there is a difference in MRI image evaluation between NCRT and NCT, and try to build a model to predict the efficacy of neoadjuvant therapy by combining multiple imaging indexes.
Read the detailed description
This study was designed as a retrospective case-control study. All 116 patients with locally advanced rectal cancer who started neoadjuvant chemoradiotherapy and underwent radical surgery in West of China Hospital and completed the required MR examination before and after neoadjuvant treatment were included from March 2016 to December 2019. MRI imaging indicators of patients before and after neoadjuvant therapy, including tumor location, longitudinal diameter, circumferential Angle, DWI signal, mrTRG and texture feature data, were retrospectively collected to analyze the changes before and after treatment, and compared with patients receiving NCT in PART1. At the same time, indicators with statistical differences will be included in the construction of models predicting different pathological outcomes after NCT and NCRT, and the efficacy of the models was evaluated through c-index values and ROC analysis of bootstrap resampling 500 times.
- Conditions
- Rectal Cancer, MRI
- Medical subject headings
- Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
pTRG
pathological tumour regression grading
Measured: within 2 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start15 Jan 2020
- Primary completion15 Jun 2020 (estimated)
- Study completion15 Jul 2020 (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.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziqiang Wang,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ziqiang Wang,MD, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392609
- Sponsor's protocol ID
- MR-NT-2020
- Status last verified
- May 2020
- First submitted
- 10 May 2020
- Last updated
- 19 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Locally Advanced Rectal Cancer Response to NCT and NCRT With MRI, and Comparison of MR Imaging Evaluation Between NCT and NCRT
- ClinicalTrials.gov ID
- NCT04392609
- Acronym / sponsor ID
- MR-NT-2020
- Conditions
- Rectal Cancer, MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Ziqiang Wang,MDUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Jun 2020 (estimated)
- Study completion
- 15 Jul 2020 (estimated)
- First posted
- 19 May 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.
This trial was designed to to study whether there is a difference in MRI image evaluation between NCRT and NCT, and try to build a model to predict the efficacy of neoadjuvant therapy by combining multiple imaging indexes.
Detailed description
This study was designed as a retrospective case-control study. All 116 patients with locally advanced rectal cancer who started neoadjuvant chemoradiotherapy and underwent radical surgery in West of China Hospital and completed the required MR examination before and after neoadjuvant treatment were included from March 2016 to December 2019. MRI imaging indicators of patients before and after neoadjuvant therapy, including tumor location, longitudinal diameter, circumferential Angle, DWI signal, mrTRG and texture feature data, were retrospectively collected to analyze the changes before and after treatment, and compared with patients receiving NCT in PART1. At the same time, indicators with statistical differences will be included in the construction of models predicting different pathological outcomes after NCT and NCRT, and the efficacy of the models was evaluated through c-index values and ROC analysis of bootstrap resampling 500 times.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with locally advanced rectal cancer who started neoadjuvant chemoradiotherapy and underwent radical surgery in West of China Hospital and completed the required MR examination before and after neoadjuvant treatment were included from March 2016 to December 2019.
Key inclusion criteria (5 listed)
- pathological diagnosis of rectal cancer;
- received neoadjuvant chemoradiotherapy before surgery;
- before neoadjuvant therapy and before surgery, the patients received thin and high resolution MRI examination of the rectum.
- before neoadjuvant therapy, colonoscopy, rectal contrast-enhanced ultrasound or MRI showed that the lower margin of the tumor was within 12cm from the anal margin;
- pre-neoadjuvant clinical stage II/III (AJCC 7th edition);
Key exclusion criteria (5 listed)
- simultaneous distant metastatic tumor should be considered at the first diagnosis;
- patients with distant metastasis were not considered at the initial diagnosis;
- with other malignant tumors;
- before neoadjuvant therapy, patients had received other relevant treatments;
- to undergo palliative surgery or emergency surgery in the course of neoadjuvant therapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pTRG
Time frame: within 2 week after surgery
pathological tumour regression grading
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
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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.
1 site 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 and MRI, run by Ziqiang Wang,MD 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 5 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 19 May 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 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?
Contact Ziqiang Wang, MD (18980602028, wangtrial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pTRG (time frame: within 2 week 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 19 May 2020.