Rectal Cancer, AdenocarcinomaNCT07107815
A Study On The Prediction of Neoadjuvant Efficacy For Rectal Cancer Based On MR Cytometry Imaging and Deep-radiomics
An observational study of Rectal Cancer, Adenocarcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study employed MR cytometry imaging combined with deep-radiomic research methods to predict the heterogeneity of rectal cancer, and constructed a model to predict the sensitivity to neoadjuvant therapy and potential mechanisms, assisting clinicians in early identification of high-risk tumors and patients with… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Cancer, Adenocarcinoma
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2025to 31 Dec 2028
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chinese patients diagnosed with rectal cancer through pathological examination
Who may be able to join
- Newly diagnosed rectal adenocarcinoma without previous treatment
- Complete radical surgery in the institute
- Complete rectal MRI within 2 weeks before surgery
Who cannot join
- Concomitant malignancies or systemic disease
- Inadequate MR image quality for analysis
- Incomplete clinicopathological data
- Loss of follow-up
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
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
Official title: A Study On The Prediction of Neoadjuvant Efficacy And Heterogeneity For Rectal Cancer Based On MR Cytometry Imaging and Deep-radiomics
This study employed MR cytometry imaging combined with deep-radiomic research methods to predict the heterogeneity of rectal cancer, and constructed a model to predict the sensitivity to neoadjuvant therapy and potential mechanisms, assisting clinicians in early identification of high-risk tumors and patients with treatment-susceptible rectal cancer, and selecting individualized treatment plans, thereby improving patient prognosis. To this end, the investigators need to collect the clinical diagnosis and treatment data of patients, surgical and biopsy pathological information, pre-treatment rectal MRI images and colonoscopy biopsy tissue sections, and follow up on the surgical pathological results and recurrence of patients. This study is a non-interventional diagnostic study, which does not interfere with the routine diagnosis and treatment of patients, does not affect any medical rights of patients, and does not increase any medical risks.
- Conditions
- Rectal Cancer, Adenocarcinoma
- Keywords
- rectal cancer, MR cytometry imaging, deep-radiomics, neoadjuvant therapy
- Medical subject headings
- Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response
Measured: One month after surgery
Pathological tumor regression grade
Measured: One month after surgery
progression-free survival
Measured: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Secondary outcomes (1)
Pathological differentiation grade
Measured: One month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start15 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal Cancer, AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107815
- Sponsor's protocol ID
- NCC2025C-250
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao Q, Shi D, Zhong H, Jin C, Wang Z, Shi Z, Li L, Wang B, Jiang Y, Feiweier T, Xu J, Guo H, Zhang H. The predictive value of MR cytometry in histological differentiation of rectal cancer: an exploratory study. Eur Radiol. 2026 Jun;36(6):5155-5168. doi: 10.1007/s00330-026-12341-w. Epub 2026 Jan 30.
PubMed 41617831
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study On The Prediction of Neoadjuvant Efficacy And Heterogeneity For Rectal Cancer Based On MR Cytometry Imaging and Deep-radiomics
- ClinicalTrials.gov ID
- NCT07107815
- Acronym / sponsor ID
- NCC2025C-250
- Conditions
- Rectal Cancer, Adenocarcinoma
- Keywords
- rectal cancer, MR cytometry imaging, deep-radiomics, neoadjuvant therapy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Aug 2025 (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 employed MR cytometry imaging combined with deep-radiomic research methods to predict the heterogeneity of rectal cancer, and constructed a model to predict the sensitivity to neoadjuvant therapy and potential mechanisms, assisting clinicians in early identification of high-risk tumors and patients with treatment-susceptible rectal cancer, and selecting individualized treatment plans, thereby improving patient prognosis. To this end, the investigators need to collect the clinical diagnosis and treatment data of patients, surgical and biopsy pathological information, pre-treatment rectal MRI images and colonoscopy biopsy tissue sections, and follow up on the surgical pathological results and recurrence of patients. This study is a non-interventional diagnostic study, which does not interfere with the routine diagnosis and treatment of patients, does not affect any medical rights of patients, and does not increase any medical risks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chinese patients diagnosed with rectal cancer through pathological examination
Key inclusion criteria (3 listed)
- Newly diagnosed rectal adenocarcinoma without previous treatment
- Complete radical surgery in the institute
- Complete rectal MRI within 2 weeks before surgery
Key exclusion criteria (4 listed)
- Concomitant malignancies or systemic disease
- Inadequate MR image quality for analysis
- Incomplete clinicopathological data
- Loss of follow-up
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
Pathological complete response
Time frame: One month after surgery
Pathological tumor regression grade
Time frame: One month after surgery
progression-free survival
Time frame: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
1 secondary outcome
Pathological differentiation grade
Time frame: One month after surgery
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 6 Aug 2025.
- Derived from this study: PubMed 41617831Zhao Q, Shi D, Zhong H, Jin C, Wang Z, Shi Z, Li L, Wang B, Jiang Y, Feiweier T, Xu J, Guo H, Zhang H. The predictive value of MR cytometry in histological differentiation of rectal cancer: an exploratory study. Eur Radiol. 2026 Jun;36(6):5155-5168. doi: 10.1007/s00330-026-12341-w. Epub 2026 Jan 30.
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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.
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?
An observational study of Rectal Cancer, Adenocarcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 3 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 6 Aug 2025. 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?
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 complete response (time frame: One month after surgery). The study lists 3 primary outcomes in all. 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 NCT07107815, which also lists 1 linked publication.
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 6 Aug 2025.