Rectal CancerNCT06746298
A Prospective Study of Expression Profiling-based Assessment of the Efficacy of Neoadjuvant Therapy for Rectal Cancer
An observational study of Rectal Cancer and Neoadjuvant Therapy, run by Shanghai Minimally Invasive Surgery Center.
Trial summary
This is a prospective study of expression profiling-based assessment of the efficacy of neoadjuvant therapy for rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Neoadjuvant Therapy
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 May 2027
- How long will I take part?
- 60 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rectal cancer patients intended for neoadjuvant therapy
Who may be able to join
- Age ≥18 years, male or infertile female
- Patients with rectal adenocarcinoma diagnosed by colonoscopic biopsy
- Neoadjuvant therapy according to guideline recommendations
- Endoscopic biopsy with access to biopsy tissue for subsequent RNA-seq testing
- Patients who do not have a combination of primary malignant tumors elsewhere.
- Patients who understand the purpose of the trial, participate voluntarily and sign an informed consent form.
Who cannot join
- Samples are not collected, stored, or processed in accordance with specified requirements
- Sample does not meet the requirements for subsequent RNA-seq testing
- Cases enrolled with a subsequent diagnosis other than rectal adenocarcinoma.
- The patient refuses or is unable to complete the entire neoadjuvant treatment
- Lack of post-neoadjuvant imaging results and lack of routine postoperative pathology results.
- Other patients who, in the judgment of the investigator, do not meet the enrollment requirements
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This is a prospective study of expression profiling-based assessment of the efficacy of neoadjuvant therapy for rectal cancer.
- Conditions
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Rectal cancer patients receiving neoadjuvant therapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: From the start of the neoadjuvant therapy until just before surgery
Secondary outcomes (3)
Overall survival
The time from the start of treatment to death due to any cause.
Measured: 3 years
Progression free survival
The period from the date of beginning treatment until the date of disease progression or death from any cause
Measured: 3 years
Total resection rate
Surgically removed tissue without residual cancer cells
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 posted24 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2027 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Shanghai Minimally Invasive Surgery Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746298
- Sponsor's protocol ID
- RNA-seq-Neo
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Expression Profiling-based Assessment of the Efficacy of Neoadjuvant Therapy for Rectal Cancer
- ClinicalTrials.gov ID
- NCT06746298
- Acronym / sponsor ID
- RNA-seq-Neo
- Conditions
- Rectal Cancer, Neoadjuvant Therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Shanghai Minimally Invasive Surgery CenterUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 24 Dec 2024 (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 is a prospective study of expression profiling-based assessment of the efficacy of neoadjuvant therapy for rectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rectal cancer patients receiving neoadjuvant therapy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rectal cancer patients intended for neoadjuvant therapy
Key inclusion criteria (6 listed)
- Age ≥18 years, male or infertile female
- Patients with rectal adenocarcinoma diagnosed by colonoscopic biopsy
- Neoadjuvant therapy according to guideline recommendations
- Endoscopic biopsy with access to biopsy tissue for subsequent RNA-seq testing
- Patients who do not have a combination of primary malignant tumors elsewhere.
Key exclusion criteria (6 listed)
- Samples are not collected, stored, or processed in accordance with specified requirements
- Sample does not meet the requirements for subsequent RNA-seq testing
- Cases enrolled with a subsequent diagnosis other than rectal adenocarcinoma.
- The patient refuses or is unable to complete the entire neoadjuvant treatment
- Lack of post-neoadjuvant imaging results and lack of routine postoperative pathology results.
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
Objective Response Rate
Time frame: From the start of the neoadjuvant therapy until just before surgery
The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST)
3 secondary outcomes
Overall survival
Time frame: 3 years
Progression free survival
Time frame: 3 years
Total resection rate
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 24 Dec 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Neoadjuvant Therapy, run by Shanghai Minimally Invasive Surgery Center.
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 6 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: opening soon, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Jing Sun (+86-13524284622, sj117788@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: From the start of the neoadjuvant therapy until just before 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 24 Dec 2024.